Patents whose numbers are in italics have been extended under 35 USC 156. Unless otherwise noted, all expiration dates include applicable Sec. 156 and pediatric (PED) extensions.
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Dec 15, 2028 | Orphan Designation: Prevention of graft versus host disease Approved Labeled Indication: prophylaxis of acute graft versus host disease (aGVHD), in combination with a calcineurin inhibitor and methotrexate, in adults and pediatric patients 2 years of age and older undergoing hematopoietic stem cell transplantation (HSCT) from a matched or 1 allele-mismatched unrelated-donor Exclusivity Protected Indication: prophylaxis of acute graft versus host disease (aGVHD) in adults and pediatric patients 2 years of age and older undergoing hematopoietic stem cell transplantation (HSCT) from a matched or 1 allele-mismatched unrelated-donor |
abobotulinumtoxinA (For Injection) (Intramuscular) Dysport
NDA Applicant: Ipsen Biopharm Limited BLA No.: 125274 Prod. No.: 001 Rx (300UNITS); 002 Rx (500UNITS)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Jul 29, 2023 | Orphan Designation: Treatment of dynamic muscle contractures in pediatric cerebral palsy patients. Approved Labeled Indication: Treatment of lower limb spasticity in pediatric patients 2 years of age and older Exclusivity Protected Indication: Treatment of lower limb spasticity in pediatric cerebral palsy patients 2 years of age and older |
adalimumab (Injection) (Subcutaneous) Humira
NDA Applicant: AbbVie Inc. BLA No.: 125057 Prod. No.: 001 Rx (40MG/0.8ML); 002 Rx (40MG/0.8ML); 004 Rx (40MG/0.8ML); 006 Rx (40MG/0.4ML); 007 Rx (40MG/0.4ML); 008 Rx (80MG/0.8ML); 009 Rx (80MG/0.8ML); 010 Rx (20MG/0.2ML); 011 Rx (10MG/0.1ML) BLA No.: 125057 Prod. No.: 003 Disc (20MG/0.4ML); 005 Disc (10MG/0.2ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6805686 Autoinjector with extendable needle protector shroud Claim Types: Device; Method of administration Pat. Sub. Date(s): None | May 6, 2023 | |
| Pat. No. 8231876 Purified antibody composition Claim Types: Product-by-process; Drug in a container Pat. Sub. Date(s): None | Apr 4, 2027 | |
| Pat. No. 8420081 Antibody formulations and methods of making same Claim Types: Formulation; Product-by-process; Device; Drug in a container; Process Pat. Sub. Date(s): None | Jan 13, 2030 | |
| Pat. No. 8663945 Methods of producing anti-TNF-alpha antibodies in mammalian cell culture Claim Types: Process Pat. Sub. Date(s): None | Sep 13, 2027 | |
| Pat. No. 8708968 Removal of needle shields from syringes and automatic injection devices Claim Types: Device Pat. Sub. Date(s): None | Jan 24, 2032 | |
| Pat. No. 8715664 Use of human TNF.alpha. antibodies for treatment of erosive polyarthritis Claim Types: Method of use Pat. Sub. Date(s): None | Jul 24, 2027 | |
| Pat. No. 8808700 Use of TNF alpha inhibitor for treatment of erosive polyarthritis Claim Types: Method of use Pat. Sub. Date(s): None | May 16, 2026 | |
| Pat. No. 8883156 Purified antibody composition Claim Types: Method of use Pat. Sub. Date(s): None | Apr 4, 2027 | |
| Pat. No. 8889136 Multiple-variable dose regimen for treating TNF.alpha.-related disorders Claim Types: Dosaage regimen Pat. Sub. Date(s): None | Oct 9, 2027 | |
| Pat. No. 8895009 Purified antibody composition Claim Types: Formulation Pat. Sub. Date(s): None | Apr 4, 2027 | |
| Pat. No. 8906372 Purified antibody composition Claim Types: Method of use Pat. Sub. Date(s): None | Apr 4, 2027 | |
| Pat. No. 8906373 Use of TNF-alpha inhibitor for treatment of psoriasis Claim Types: Method of use Pat. Sub. Date(s): None | Jul 18, 2023 | |
| Pat. No. 8906646 Fed-batch method of making human anti-TNF-alpha antibody Claim Types: Process Pat. Sub. Date(s): None | Sep 13, 2027 | |
| Pat. No. 8911737 Methods of administering anti-TNF.alpha. antibodies Claim Types: Method of use Pat. Sub. Date(s): None | Jun 5, 2022 | |
| Pat. No. 8911964 Fed-batch method of making human anti-TNF-alpha antibody Claim Types: Process Pat. Sub. Date(s): None | Sep 13, 2027 | |
| Pat. No. 8916153 Purified antibody composition Claim Types: Composition Pat. Sub. Date(s): None | Apr 4, 2027 | |
| Pat. No. 8926975 Method of treating ankylosing spondylitis Claim Types: Method of use Pat. Sub. Date(s): None | Jun 8, 2027 | |
| Pat. No. 8961973 Multiple-variable dose regimen for treating TNF.alpha.-related disorders Claim Types: Dosaage regimen Pat. Sub. Date(s): None | Apr 11, 2025 | |
| Pat. No. 8961974 Multiple-variable dose regimen for treating TNF.alpha.-related disorders Claim Types: Dosaage regimen Pat. Sub. Date(s): None | Apr 11, 2025 | |
| Pat. No. 8974790 Methods of administering anti-TNF.alpha. antibodies Claim Types: Dosaage regimen Pat. Sub. Date(s): None | Jun 5, 2022 | |
| Pat. No. 8986693 Use of TNF.alpha. inhibitor for treatment of psoriasis Claim Types: Dosaage regimen Pat. Sub. Date(s): None | Apr 11, 2025 | |
| Pat. No. 8992926 Methods of administering anti-TNF.alpha. antibodies Claim Types: Dosaage regimen Pat. Sub. Date(s): None | Jun 5, 2022 | |
| Pat. No. 8999337 Methods for treating juvenile idiopathic arthritis by inhibition of TNF.alpha. Claim Types: Method of use Pat. Sub. Date(s): None | Feb 6, 2031 | |
| Pat. No. 9061005 Multiple-variable dose regimen for treating idiopathic inflammatory bowel disease Claim Types: Dosaage regimen Pat. Sub. Date(s): None | Apr 11, 2025 | |
| Pat. No. 9062106 Methods for controlling the galactosylation profile of recombinantly-expressed proteins Claim Types: Process Pat. Sub. Date(s): None | Apr 26, 2032 | |
| Pat. No. 9067992 Use of TNF.alpha. inhibitor for treatment of psoriatic arthritis Claim Types: Method of use Pat. Sub. Date(s): None | Jul 18, 2023 | |
| Pat. No. 9085618 Low acidic species compositions and methods for producing and using the same Claim Types: Formulation; Method of use Pat. Sub. Date(s): None | Mar 14, 2033 | |
| Pat. No. 9085619 Anti-TNF antibody formulations Claim Types: Composition; Formulation Pat. Sub. Date(s): None | Nov 28, 2028 | |
| Pat. No. 9085620 Use of TNF.alpha. inhibitor for treatment of psoriatic arthritis Claim Types: Method of administration; Process Pat. Sub. Date(s): None | Jul 18, 2023 | |
| Pat. No. 9090688 Methods for controlling the galactosylation profile of recombinantly-expressed proteins Claim Types: Process Pat. Sub. Date(s): None | Apr 26, 2032 | |
| Pat. No. 9090689 Use of TNF.alpha. inhibitor for treatment of psoriasis Claim Types: Method of administration; Process Pat. Sub. Date(s): None | Jul 18, 2023 | |
| Pat. No. 9090867 Fed-batch method of making anti-TNF-alpha antibody Claim Types: Process Pat. Sub. Date(s): None | Sep 13, 2027 | |
| Pat. No. 9096666 Purified antibody composition Claim Types: Formulation Pat. Sub. Date(s): None | Apr 4, 2027 | |
| Pat. No. 9102723 Purified antibody composition Claim Types: Process; Product-by-process; Method of use Pat. Sub. Date(s): None | Apr 4, 2027 | |
| Pat. No. 9150645 Cell culture methods to reduce acidic species Claim Types: Process Pat. Sub. Date(s): None | May 13, 2033 | |
| Pat. No. 9181337 Modulated lysine variant species compositions and methods for producing and using the same Claim Types: Formulation Pat. Sub. Date(s): None | Mar 14, 2033 | |
| Pat. No. 9181572 Methods to modulate lysine variant distribution Claim Types: Process Pat. Sub. Date(s): None | Mar 14, 2033 | |
| Pat. No. 9187559 Multiple-variable dose regimen for treating idiopathic inflammatory bowel disease Claim Types: Dosaage regimen Pat. Sub. Date(s): None | Apr 11, 2025 | |
| Pat. No. 9234032 Fed-batch methods for producing adalimumab Claim Types: Process Pat. Sub. Date(s): None | Sep 13, 2027 | |
| Pat. No. 9266949 Low acidic species compositions and methods for producing and using the same Claim Types: Process Pat. Sub. Date(s): None | May 13, 2033 | |
| Pat. No. 9273132 Purified antibody composition Claim Types: Method of use Pat. Sub. Date(s): None | Apr 4, 2027 | |
| Pat. No. 9284370 Methods for treating juvenile idiopathic arthritis Claim Types: Method of use Pat. Sub. Date(s): None | Jun 10, 2028 | |
| Pat. No. 9284371 Methods of producing adalimumab Claim Types: Process Pat. Sub. Date(s): None | Sep 13, 2027 | |
| Pat. No. 9290568 Methods to control protein heterogeneity Claim Types: Process Pat. Sub. Date(s): None | Mar 14, 2033 | |
| Pat. No. 9315574 Low acidic species compositions and methods for producing and using the same Claim Types: Process Pat. Sub. Date(s): None | Apr 21, 2033 | |
| Pat. No. 9328165 Purified antibody composition Claim Types: Formulation Pat. Sub. Date(s): None | Apr 4, 2027 | |
| Pat. No. 9334319 Low acidic species compositions Claim Types: Formulation claimed by its inherent performace characteristics Pat. Sub. Date(s): None | Mar 14, 2033 | |
| Pat. No. 9339610 Removal of needle shield from syringes and automatic injection devices Claim Types: Device Pat. Sub. Date(s): None | Jan 24, 2032 | |
| Pat. No. 9346879 Protein purification methods to reduce acidic species Claim Types: Process Pat. Sub. Date(s): None | Mar 14, 2033 | |
| Pat. No. 9359434 Cell culture methods to reduce acidic species Claim Types: Process Pat. Sub. Date(s): None | Mar 14, 2033 | |
| Pat. No. 9499614 Methods for modulating protein glycosylation profiles of recombinant protein therapeutics using monosaccharides and oligosaccharides Claim Types: Process Pat. Sub. Date(s): None | Mar 14, 2034 | |
| Pat. No. 9499616 Modulated lysine variant species compositions and methods for producing and using the same Claim Types: Process Pat. Sub. Date(s): None | Mar 14, 2033 | |
| Pat. No. 9505834 Methods for controlling the galactosylation profile of recombinantly-expressed proteins Claim Types: Process Pat. Sub. Date(s): None | Apr 26, 2032 | |
| Pat. No. 9512216 Use of TNF.alpha. inhibitor Claim Types: Method of use Pat. Sub. Date(s): None | Apr 11, 2025 | |
| Pat. No. 9522953 Low acidic species compositions and methods for producing and using the same Claim Types: Drug in a container; Method of use Pat. Sub. Date(s): None | Apr 26, 2032 | |
| Pat. No. 9546212 Methods of administering anti-TNF.alpha. antibodies Claim Types: Method of use Pat. Sub. Date(s): None | Jun 5, 2022 | |
| Pat. No. 9550826 Glycoengineered binding protein compositions Claim Types: Formulation Pat. Sub. Date(s): None | Nov 14, 2034 | |
| Pat. No. 9624295 Uses and compositions for treatment of psoriatic arthritis Claim Types: Method of use Pat. Sub. Date(s): None | Mar 31, 2031 | |
| Pat. No. 9669093 Methods for treating juvenile idiopathic arthritis Claim Types: Method of use Pat. Sub. Date(s): None | Jun 10, 2028 | |
| Pat. No. 9683033 Cell culture methods to reduce acidic species Claim Types: Formulation; Method of use Pat. Sub. Date(s): None | Apr 26, 2032 | |
| Pat. No. 9708400 Methods to modulate lysine variant distribution Claim Types: Formulation Pat. Sub. Date(s): None | Mar 14, 2033 | |
| Pat. No. 9913902 Purified antibody composition Claim Types: Formulation claimed by its inherent performace characteristics Pat. Sub. Date(s): None | Apr 4, 2027 | |
| Pat. No. 9957318 Protein purification methods to reduce acidic species Claim Types: Process Pat. Sub. Date(s): None | Apr 26, 2032 | |
| Pat. No. 11083792 Purified antibody composition Claim Types: Formulation claimed by its inherent performace characteristics Pat. Sub. Date(s): None | Apr 4, 2027 | |
| Pat. No. 11167030 Protein formulations and methods of making same Claim Types: Formulation Pat. Sub. Date(s): None | Nov 28, 2028 | |
| Pat. No. 11191834 Protein formulations and methods of making same Claim Types: Formulation Pat. Sub. Date(s): None | Nov 28, 2028 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Type: Orphan Drug Exclusivity | Feb 21, 2015 | Orphan Designation: Treatment of juvenile rheumatoid arthritis Approved Labeled Indication: Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 4 years of age and older. |
| Exclusivity Type: Orphan Drug Exclusivity | Sep 23, 2021 | Orphan Designation: Treatment of pediatric Crohn's disease Approved Labeled Indication: Reducing signs and symptoms and inducing and maintaining clinical remission in patients 6 years of age and older with moderately to severely active Crohn's disease who have had an inadequate response to corticosteroids or immunomodulators such as azathioprine, 6-mercaptopurine, or methotrexate. Exclusivity Protected Indication: Reducing signs and symptoms and inducing and maintaining clinical remission in patients 6 through 16 years of age with moderately to severely active Crohn's disease who have had an inadequate response to corticosteroids or immunomodulators such as azathioprine, 6-mercaptopurine, or methotrexate. |
| Exclusivity Type: Orphan Drug Exclusivity | Sep 30, 2021 | Orphan Designation: Treatment of juvenile rheumatoid arthritis Approved Labeled Indication: Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. Exclusivity Protected Indication: Treatment of polyarticular juvenile idiopathic arthritis in patients 2 to less than 4 years of age. |
| Exclusivity Type: Orphan Drug Exclusivity | Sep 9, 2022 | Orphan Designation: Treatment of moderate to severe hidradenitis suppurativa (Hurley stage 2 and Hurley stage 3 disease) Approved Labeled Indication: Treatment of moderate to severe hidradenitis suppurativa Exclusivity Protected Indication: Treatment of moderate to severe hidradenitis suppurativa |
| Exclusivity Type: Orphan Drug Exclusivity | Jun 30, 2023 | Orphan Designation: Treatment of non-infectious intermediate, posterior, or panuveitis, or chronic non-infectious anterior uveitis Approved Labeled Indication: Indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients Exclusivity Protected Indication: Indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients |
| Exclusivity Type: Orphan Drug Exclusivity | Sep 28, 2025 | Orphan Designation: Treatment of non-infectious intermediate, posterior, or panuveitis, or chronic non-infectious anterior uveitis Approved Labeled Indication: Treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older Exclusivity Protected Indication: Treatment of non-infectious intermediate, posterior, and panuveitis in pediatric patients 2 years of age and older |
| Exclusivity Type: Orphan Drug Exclusivity | Oct 16, 2025 | Orphan Designation: Treatment of moderate to severe hidradenitis suppurativa (Hurley stage 2 and Hurley stage 3 disease) Approved Labeled Indication: Treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. Exclusivity Protected Indication: Treatment of moderate to severe hidradenitis suppurativa (HS) in adolescent patients 12 years of age and older. |
| Exclusivity Type: Orphan Drug Exclusivity | Feb 24, 2028 | Orphan Designation: Treatment of pediatric patients with ulcerative colitis Approved Labeled Indication: treatment of moderately to severely active ulcerative colitis in pediatric patients 5 years of age and older. Limitations of Use: The effectiveness of HUMIRA has not been established in patients who have lost response to or were intolerant to TNF blockers. Exclusivity Protected Indication: treatment of moderately to severely active ulcerative colitis in pediatric patients 5 years of age and older. Limitations of Use: The effectiveness of HUMIRA has not been established in patients who have lost response to or were intolerant to TNF blockers. |
adalimumab-adbm (Injection) (Subcutaneous) Cyltezo
NDA Applicant: Boehringer Ingelheim Pharmaceuticals, Inc. BLA No.: 761058 Prod. No.: 001 Rx (40MG/0.8ML); 002 Rx (20MG/0.4ML); 003 Rx (10MG/0.2ML); 004 Rx (40MG/0.8ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: 1st Interchangeable Exclusivity | Date TBD |
aflibercept (Injection) (Intravitreal) Eylea
NDA Applicant: Regeneron Pharmaceuticals, Inc. BLA No.: 125387 Prod. No.: 001 Rx (2MG/0.05ML); 002 Rx (2MG/0.05ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. D858754 Syringe cap Claim Types: Ornamental appearance of device or tablet Pat. Sub. Date(s): None | Sep 3, 2034 | |
| Pat. No. D906102 Packaging Claim Types: Ornamental appearance of device or tablet Pat. Sub. Date(s): None | Dec 29, 2035 | |
| Pat. No. D934069 Packaging Claim Types: Ornamental appearance of device or tablet Pat. Sub. Date(s): None | Oct 26, 2036 | |
| Pat. No. D961376 Packaging Claim Types: Ornamental appearance of device or tablet Pat. Sub. Date(s): None | Aug 23, 2037 | |
| Pat. No. D961377 Packaging Claim Types: Ornamental appearance of device or tablet Pat. Sub. Date(s): None | Aug 23, 2037 | |
| Pat. No. 7070959 [Extended 1119 days (3.1 years)] Modified chimeric polypeptides with improved pharmacokinetic properties Claim Types: Nucleic Acid; Expression Vector; Process Pat. Sub. Date(s): None | Jun 16, 2023 | |
| Pat. No. 9222106 Enhanced expression and stability regions Claim Types: Cell; Process Pat. Sub. Date(s): None | Jun 4, 2028 | |
| Pat. No. 9254338 Use of a VEGF antagonist to treat angiogenic eye disorders Claim Types: Method of use Pat. Sub. Date(s): None | May 22, 2032 | |
| Pat. No. 9669069 Use of a VEGF antagonist to treat angiogenic eye disorders Claim Types: Method of use Pat. Sub. Date(s): None | Jan 11, 2032 | |
| Pat. No. 9816110 CHO integration sites and uses thereof Claim Types: Cell; Process Pat. Sub. Date(s): None | Oct 21, 2035 | |
| Pat. No. 10130681 Use of a VEGF antagonist to treat angiogenic eye disorders Claim Types: Method of use Pat. Sub. Date(s): None | Jan 11, 2032 | |
| Pat. No. 10406226 Method of manufacturing VEGF antagonist fusion proteins Claim Types: Process Pat. Sub. Date(s): None | Mar 22, 2026 | |
| Pat. No. 10415055 Enhanced expression and stability regions Claim Types: Cell; Process Pat. Sub. Date(s): None | Jun 4, 2028 | |
| Pat. No. 10464992 VEGF antagonist formulations suitable for intravitreal administration Claim Types: Drug in a container; Formulation Pat. Sub. Date(s): None | Jun 14, 2027 | |
| Pat. No. 10669594 Compositions and methods for detecting a biological contaminant Claim Types: Analytical Method Pat. Sub. Date(s): None | Feb 12, 2037 | |
| Pat. No. 10828354 Laser-assisted intradermal administration of active substances Claim Types: Method of use; Method of improving a treatment Pat. Sub. Date(s): None | Jan 11, 2032 | |
| Pat. No. 10857205 Use of a VEGF antagonist to treat angiogenic eye disorders Claim Types: Method of use Pat. Sub. Date(s): None | Jan 11, 2032 | |
| Pat. No. 10857231 Formulations of VEG antagonist fusion proteins and method of manufacturing them Claim Types: Formulation; Formulation claimed by its inherent performace characteristics; Process Pat. Sub. Date(s): None | Disclaimer filed on March 14, 2022 | |
| Pat. No. 10888601 Use of a VEGF antagonist to treat angiogenic eye disorders Claim Types: Dosaage regimen Pat. Sub. Date(s): None | Jan 11, 2032 | |
| Pat. No. 10905786 Sterilisation method Claim Types: Process Pat. Sub. Date(s): None | Mar 6, 2038 | |
| Pat. No. 10918754 Sterilisation method Claim Types: Process Pat. Sub. Date(s): None | Mar 6, 2038 | |
| Pat. No. 10927342 Taurine supplemented cell culture medium and methods of use Claim Types: Process Pat. Sub. Date(s): None | Aug 3, 2036 | |
| Pat. No. 10973879 Use of a VEGF antagonist to treat angiogenic eye disorders Claim Types: Method of use Pat. Sub. Date(s): None | May 17, 2039 | |
| Pat. No. 11053280 Anti-VEGF protein compositions and methods for producing the same Claim Types: Process Pat. Sub. Date(s): None | Aug 18, 2040 | |
| Pat. No. 11066458 VEGF antagonist formulations suitable for intravitreal administration Claim Types: Drug in a container; Formulation Pat. Sub. Date(s): None | Jun 14, 2027 | |
| Pat. No. 11084865 VEGF antagonist formulations suitable for intravitreal administration Claim Types: Drug in a container; Formulation Pat. Sub. Date(s): None | Jun 14, 2027 | |
| Pat. No. 11104715 Methods for producing aflibercept in chemically defined media having reduced aflibercept variants Claim Types: Process Pat. Sub. Date(s): None | Aug 18, 2040 | |
| Pat. No. 11160918 Medical device packaging and related methods Claim Types: Kit Pat. Sub. Date(s): None | Jul 29, 2039 | |
| Pat. No. 11174283 Anti-VEGF protein compositions and methods for producing the same Claim Types: Process Pat. Sub. Date(s): None | Aug 18, 2040 | |
| Pat. No. 11186625 Anti-VEGF protein compositions and methods for producing the same Claim Types: Composition; Product-by-process Pat. Sub. Date(s): None | Aug 18, 2040 | |
| Pat. No. 11253572 Use of a VEGF antagonist to treat angiogenic eye disorders Claim Types: Method of use Pat. Sub. Date(s): None | Jan 11, 2032 | |
| Pat. No. 11299532 Anti-VEGF protein compositions and methods for producing the same Claim Types: Process Pat. Sub. Date(s): None | Aug 18, 2040 | |
| Pat. No. 11306135 Anti-VEGF protein compositions and methods for producing the same Claim Types: Composition; Product-by-process Pat. Sub. Date(s): None | Aug 18, 2040 | |
| Pat. No. 11332771 Serum-free cell culture medium Claim Types: Process Pat. Sub. Date(s): None | Mar 14, 2034 | |
| Pat. No. 11433186 Devices and methods for precision dose delivery Claim Types: Device; Process Pat. Sub. Date(s): None | Dec 12, 2038 | |
| Pat. No. 11439758 Devices and methods for precision dose delivery Claim Types: Device Pat. Sub. Date(s): None | Jun 4, 2040 | |
| Pat. No. 11459373 Anti-VEGF protein compositions and methods for producing the same Claim Types: Process Pat. Sub. Date(s): None | Aug 18, 2040 | |
| Pat. No. 11459374 Anti-VEGF protein compositions and methods for producing the same Claim Types: Process Pat. Sub. Date(s): None | Aug 18, 2040 | |
| Pat. No. 11472861 Methods for producing aflibercept in chemically defined media having reduced aflibercept variants Claim Types: Process Pat. Sub. Date(s): None | Aug 18, 2040 | |
| Pat. No. 11478588 Needle shield grip devices and related methods Claim Types: Device Pat. Sub. Date(s): None | Jul 25, 2040 | |
| Pat. No. 11485770 Anti-VEGF protein compositions and methods for producing the same Claim Types: Cell culture medium Pat. Sub. Date(s): None | Aug 18, 2040 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Type: Orphan Drug Exclusivity | Feb 8, 2030 | Orphan Designation: Treatment of Retinopathy of Prematurity Approved Labeled Indication: treatment of retinopathy of prematurity (ROP) Exclusivity Protected Indication: treatment of retinopathy of prematurity (ROP) |
agalsidase beta (For Injection) (Intravenous) Fabrazyme
NDA Applicant: Genzyme Corporation BLA No.: 103979 Prod. No.: 001 Rx (35MG); 002 Rx (5MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Apr 24, 2010 | Orphan Designation: Treatment of Fabry's disease. Approved Labeled Indication: For use in patients with Fabry disease to reduce globotriaosylceramide (GL-3) deposition in capillary endothelium of the kidney and certain other cell types |
| Exclusivity Type: Orphan Drug Exclusivity | Mar 11, 2028 | Orphan Designation: Treatment of Fabry's disease. Approved Labeled Indication: treatment of adult and pediatric patients 2 years of age and older with confirmed Fabry disease Exclusivity Protected Indication: treatment of pediatric patients 2 years of age up to patients 8 years of age with confirmed Fabry disease |
aldesleukin (For Injection) (Intravenous) Proleukin
NDA Applicant: Clinigen, Inc. BLA No.: 103293 Prod. No.: 001 Rx (22MILLION INTERNATIONAL UNITS (1.3MG))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | May 5, 1999 | Orphan Designation: Treatment of metastatic renal cell carcinoma. Approved Labeled Indication: Treatment of adults (>18 years old) with metastatic renal cell carcinoma. |
| Exclusivity Type: Orphan Drug Exclusivity | Jan 9, 2005 | Orphan Designation: Treatment of metastatic melanoma. Approved Labeled Indication: Treatment of adults with metastatic melanoma. |
alemtuzumab (Injection) (Intravenous) Campath; Lemtrada
NDA Applicant: Genzyme Corporation BLA No.: 103948 Prod. No.: 002 Rx (12MG/1.2ML (10MG/ML)); 003 Rx (30MG/1ML) BLA No.: 103948 Prod. No.: 001 Disc (30MG (10MG/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | May 7, 2008 | Orphan Designation: Treatment of chronic lymphocytic leukemia. Approved Labeled Indication: The treatment of patients with B-cell chronic lymphocytic leukemia who have been treated with alkylating agents and who have failed fludarabine therapy. |
alglucosidase alfa (For Injection) (Intravenous) Myozyme
NDA Applicant: Genzyme Corporation BLA No.: 125141 Prod. No.: 001 Disc (50MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Apr 28, 2013 | Orphan Designation: This Orphan Designation could not be obtained via our automated process due to a trademark mismatch between the Purple Book and the FDA's "Orphan Drug Designations and Approvals" search engine. Please use the FDA's search engine to manually look up the orphan designation. |
alirocumab (Injection) (Subcutaneous) Praluent
NDA Applicant: Regeneron Pharmaceuticals, Inc. BLA No.: 125559 Prod. No.: 001 Rx (75MG/ML); 002 Rx (150MG/ML) BLA No.: 125559 Prod. No.: 003 Disc (75MG/ML); 004 Disc (150MG/ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Apr 1, 2028 | Orphan Designation: Treatment of homozygous familial hypercholesterolemia Approved Labeled Indication: as an adjunct to other LDL-C-lowering therapies in adult patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C Exclusivity Protected Indication: as an adjunct to other LDL-C-lowering therapies in adult patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C |
Allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen-dsat (Cell Sheets) (Topical) StrataGraft
NDA Applicant: Stratatech Corporation BLA No.: 125730 Prod. No.: 001 Rx (100CM SQUARED)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Jun 15, 2028 | Orphan Designation: Treatment of hospitalized patients with complex skin defects resulting from partial and full thickness skin burns requiring excision and grafting Approved Labeled Indication: Treatment of adults with thermal burns containing intact dermal elements for which surgical intervention is clinically indicated (deep partial-thickness burns) Exclusivity Protected Indication: Treatment of adults with thermal burns containing intact dermal elements for which surgical intervention is clinically indicated (deep partial-thickness burns) |
| Exclusivity Type: Ref. Product Exclusivity | Jun 15, 2033 |
allogeneic processed thymus tissue-agdc (For Suspension) (Implantation) Rethymic
NDA Applicant: Enzyvant Therapeutics GmbH BLA No.: 125685 Prod. No.: 001 Rx (SEMI-QUANTITATIVE)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Oct 8, 2028 | Orphan Designation: Treatment of congenital athymia Approved Labeled Indication: immune reconstitution in pediatric patients with congenital athymia Exclusivity Protected Indication: immune reconstitution in pediatric patients with congenital athymia |
| Exclusivity Type: Ref. Product Exclusivity | Oct 8, 2033 |
Alpha-1-Proteinase Inhibitor (Human) (For Injection) (Intravenous) Prolastin, Prolastin-C
NDA Applicant: Grifols Therapeutics LLC BLA No.: 103174 Prod. No.: 001 Rx (1000MG); 003 Rx (1000MG/20ML); 004 Rx (4000MG/80ML); 005 Rx (500MG/10ML) BLA No.: 103174 Prod. No.: 002 Disc (500MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Dec 2, 1994 | Orphan Designation: For replacement therapy in the alpha-1-proteinase inhibitor congenital deficiency state. Approved Labeled Indication: For chronic replacement therapy of individuals having congenital deficiency of alpha1- proteinase inhibitor with clinically demonstrable panacinar emphysema. |
anacaulase-bcdb (For Topical Gel) (Topical) Nexobrid
NDA Applicant: MediWound, Ltd. BLA No.: 761192 Prod. No.: 001 Disc (8.8% (1.94GM)); 002 Disc (8.8% (4.85GM))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Dec 28, 2029 | Orphan Designation: Debridement of acute, deep dermal burns in hospitalized patients Approved Labeled Indication: eschar removal in adults with deep partial thickness (DPT) and/or full thickness (FT) thermal burns Exclusivity Protected Indication: eschar removal in hospitalized adults with deep partial thickness (DPT) and/or full thickness (FT) thermal burns |
anakinra (Injection) (Subcutaneous) Kineret
NDA Applicant: Swedish Orphan Biovitrum AB (publ) BLA No.: 103950 Prod. No.: 001 Rx (100MG/0.67ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Dec 21, 2019 | Orphan Designation: Treatment of cryopyrin-associated periodic syndromes Approved Labeled Indication: Treatment of neonatal-onset multisystem inflammatory disease (NOMID) |
| Exclusivity Type: Orphan Drug Exclusivity | Dec 18, 2027 | Orphan Designation: Treatment of Deficiency of IL-1 Receptor Antagonist Approved Labeled Indication: treatment of Deficiency of Interleukin-1 Receptor Antagonist (DIRA) Exclusivity Protected Indication: treatment of Deficiency of Interleukin-1 Receptor Antagonist (DIRA) |
ansuvimab-zykl (For Injection) (Intravenous) Ebanga
NDA Applicant: Emergent Manufacturing Operations Baltimore LLC BLA No.: 761172 Prod. No.: 001 Rx (400MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Dec 21, 2027 | Orphan Designation: Treatment of Ebola Virus Disease Approved Labeled Indication: treatment of infection caused by Zaire ebolavirus in adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Zaire ebolavirus infection Exclusivity Protected Indication: treatment of infection caused by Zaire ebolavirus in adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Zaire ebolavirus infection |
Anthrax Immune Globulin Intravenous (Human) (Injection) (Intravenous) Anthrasil
NDA Applicant: Emergent BioSolutions Canada Inc. BLA No.: 125562 Prod. No.: 001 Rx (>=60 U)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Mar 24, 2022 | Orphan Designation: Treatment of inhalational anthrax Approved Labeled Indication: Treatment of inhalational anthrax in adult and pediatric patients in combination with appropriate antibacterial drugs Exclusivity Protected Indication: Treatment of inhalational anthrax in adult and pediatric patients in combination with appropriate antibacterial drugs |
Anthrax Vaccine Adsorbed (Injection) (Intramuscular; Subcutaneous) Biothrax
NDA Applicant: Emergent BioDefense Operations Lansing LLC BLA No.: 103821 Prod. No.: 001 Rx (0.5ML); 002 Rx (0.5ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Nov 23, 2022 | Orphan Designation: For post-exposure prophylaxis of anthrax disease resulting from suspected or confirmed Bacillus anthracis exposure Approved Labeled Indication: For post-exposure prophylaxis of disease following suspected or confirmed Bacillus anthracis exposure, when administered in conjunction with recommended antibacterial drugs. Exclusivity Protected Indication: For post-exposure prophylaxis of disease following suspected or confirmed Bacillus anthracis exposure, when administered in conjunction with recommended antibacterial drugs. |
Anti-Inhibitor Coagulant Complex (For Injection) (Intravenous) Autoplex, Feiba Nf, Feiba Vh
NDA Applicant: Takeda Pharmaceuticals U.S.A., Inc. BLA No.: 101447 Prod. No.: 003 Rx (1000U); 004 Rx (500U); 005 Rx (2500U) BLA No.: 101447 Prod. No.: 001 Disc (1000IU); 002 Disc (500IU)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Dec 16, 2020 | Orphan Designation: This Orphan Designation could not be obtained via our automated process due to a trademark mismatch between the Purple Book and the FDA's "Orphan Drug Designations and Approvals" search engine. Please use the FDA's search engine to manually look up the orphan designation. |
Antihemophilic Factor (Recombinant) (For Injection) (Intravenous) Helixate Fs, Kogenate, Kogenate Fs
NDA Applicant: Bayer HealthCare LLC BLA No.: 103332 Prod. No.: 001 Rx (250IU); 002 Rx (500IU); 003 Rx (1000IU); 004 Rx (2000IU); 005 Rx (3000IU)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Feb 25, 2000 | Orphan Designation: This Orphan Designation could not be obtained via our automated process due to a trademark mismatch between the Purple Book and the FDA's "Orphan Drug Designations and Approvals" search engine. Please use the FDA's search engine to manually look up the orphan designation. |
Antihemophilic Factor (Recombinant), Fc Fusion protein (For Injection) (Intravenous) Eloctate
NDA Applicant: Bioverativ Therapeutics, Inc. BLA No.: 125487 Prod. No.: 001 Rx (1500IU); 002 Rx (1000IU); 003 Rx (2000IU); 004 Rx (3000IU); 005 Rx (750IU); 006 Rx (500IU); 007 Rx (250IU); 008 Rx (5000IU); 009 Rx (6000IU); 010 Rx (4000IU)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Jun 6, 2021 | Orphan Designation: Treatment of hemophilia A Approved Labeled Indication: Indicated in adults and children with Hemophilia A (congenital Factor VIII deficiency) for on-demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes. Exclusivity Protected Indication: Treatment of adults and children with Hemophilia A (congenital Factor VIII deficiency) for control and prevention of bleeding episodes, perioperative management, and routine prophylaxis to prevent or reduce the frequency of bleeding episodes. |
antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl (For Injection) (Intravenous) ALTUVIIIO
NDA Applicant: Bioverativ Therapeutics, Inc. BLA No.: 125771 Prod. No.: 001 Rx (250IU); 002 Rx (500IU); 003 Rx (750IU); 004 Rx (1000IU); 005 Rx (2000IU); 006 Rx (3000IU); 007 Rx (4000IU)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Feb 22, 2030 | Orphan Designation: Treatment of hemophilia A Approved Labeled Indication: in adults and children with hemophilia A (congenital factor VIII deficiency) for routine prophylaxis to reduce the frequency of bleeding episodes; on-demand treatment and control of bleeding episodes; and perioperative management of bleeding Exclusivity Protected Indication: in adults and children with hemophilia A (congenital factor VIII deficiency) for routine prophylaxis to reduce the frequency of bleeding episodes; on-demand treatment and control of bleeding episodes; and perioperative management of bleeding |
Antihemophilic Factor (Recombinant), Porcine Sequence (For Injection) (Intravenous) Obizur
NDA Applicant: Takeda Pharmaceuticals U.S.A., Inc. BLA No.: 125512 Prod. No.: 001 Rx (500U)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Oct 23, 2021 | Orphan Designation: Treatment and prevention of episodic bleeding in patients with inhibitor antibodies to human coagulation factor VIII Approved Labeled Indication: Treatment of bleeding episodes in adults with acquired hemophilia A. Exclusivity Protected Indication: Treatment of bleeding episodes in adults with acquired hemophilia A. |
Antihemophilic Factor/von Willebrand Factor Complex (Human) (For Injection) (Intravenous) Alphanate
NDA Applicant: Grifols Biologicals LLC BLA No.: 102475 Prod. No.: 001 Rx (250IU); 002 Rx (1000IU); 003 Rx (1500IU); 004 Rx (500IU); 005 Rx (2000IU)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Jan 31, 2014 | Orphan Designation: Treatment of von Willebrand's disease Approved Labeled Indication: For surgical and/or invasive procedures in patients with von Willebrand Disease (VWD) in whom desmopressin is either ineffective or contraindicated. It is not indicated for patients with severe VWD (Type 3) undergoing major surgery |
Antihemophilic Factor/von Willebrand Factor Complex (Human) (For Injection) (Intravenous) Humate-P
NDA Applicant: CSL Behring GmbH BLA No.: 103960 Prod. No.: 001 Rx (1000IU); 002 Rx (250IU); 003 Rx (500IU)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Apr 1, 2006 | Orphan Designation: Treatment of patients with von Willebrand's disease Approved Labeled Indication: (1) In adult patients for treatment and prevention of bleeding in hemophilia A (classic hemophilia) and (2) in adult and pediatric patients for treatment of spontaneous and trauma-induced bleeding episodes in severe von Willebrand disease, and in mild and moderate von Willebrand disease where use of desmopressin is known or suspected to be inadequate. |
Antithrombin (Recombinant) (For Injection) (Intravenous) Atryn
NDA Applicant: rEVO Biologics, Inc. BLA No.: 125284 Prod. No.: 001 Disc (1750IU); 002 Disc (525IU)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Feb 6, 2016 | Orphan Designation: Treatment of congenital antithrombin deficiency to prevent the occurrence of serious, potentially life-threatening venous thromboembolisms which may develop as a result of surgical or obstetrical procedures Approved Labeled Indication: Prevention of peri-operative and peri-partum thromboembolic events, in hereditary antithrombin deficient patients. |
Antithrombin III (Human) (For Injection) (Intravenous) Thrombate Iii
NDA Applicant: Grifols Therapeutics LLC BLA No.: 103196 Prod. No.: 001 Rx (500IU)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Dec 30, 1998 | Orphan Designation: For replacement therapy in congenital deficiency of AT-III for prevention and treatment of thrombosis and pulmonary emboli. |
aprotinin (Injection) (Intravenous) Trasylol
NDA Applicant: Bayer HealthCare Pharmaceuticals Inc. BLA No.: 020304 Prod. No.: 001 Disc (1,000,000KIU/100ML (10,000KIU/ML)); 002 Disc (2,000,000KIU/200ML (10,000KIU/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Dec 29, 2000 | Orphan Designation: For prophylactic use to reduce perioperative blood loss and the homologous blood transfusion requirement in patients undergoing cardiopulmonary bypass surgery in the course of repeat coronary artery bypass graft surgery, and in selected cases of primary c |
asfotase alfa (Injection) (Subcutaneous) Strensiq
NDA Applicant: Alexion Pharmaceuticals, Inc. BLA No.: 125513 Prod. No.: 001 Rx (18MG/0.45ML); 002 Rx (28MG/0.7ML); 003 Rx (40MG/ML); 004 Rx (80MG/0.8ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Oct 23, 2022 | Orphan Designation: Treatment of hypophosphatasia Approved Labeled Indication: For the treatment of patients with perinatal/infantile-and juvenile-onset hypophosphatasia (HPP) Exclusivity Protected Indication: For the treatment of patients with perinatal/infantile-and juvenile-onset hypophosphatasia (HPP) |
atezolizumab (Injection) (Intravenous) Tecentriq
NDA Applicant: Genentech, Inc. BLA No.: 761034 Prod. No.: 001 Rx (1200MG/20ML (60MG/ML)); 002 Rx (840MG/14ML (60MG/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Mar 18, 2026 | Orphan Designation: Treatment of small cell lung cancer (SCLC) Approved Labeled Indication: TECENTRIQ, in combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) Exclusivity Protected Indication: TECENTRIQ, in combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) |
| Exclusivity Type: Orphan Drug Exclusivity | Jul 30, 2027 | Orphan Designation: Treatment of Stage llb, llc, lll and IV melanoma Approved Labeled Indication: indicated in combination with cobimetinib and vemurafenib for the treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma Exclusivity Protected Indication: indicated in combination with cobimetinib and vemurafenib for the treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma |
| Exclusivity Type: Orphan Drug Exclusivity | Dec 9, 2029 | Orphan Designation: treatment of soft tissue sarcoma Approved Labeled Indication: as a single agent for the treatment of adult and pediatric patients 2 years of age and older with unresectable or metastatic alveolar soft part sarcoma (ASPS) Exclusivity Protected Indication: treatment of adult and pediatric patients 2 years of age and older with unresectable or metastatic alveolar soft part sarcoma (ASPS) |
atoltivimab, maftivimab, and odesivimab-ebgn (Injection) (Intravenous) Inmazeb
NDA Applicant: Regeneron Pharmaceuticals, Inc. BLA No.: 761169 Prod. No.: 001 Rx (241.7MG, 241.7MG, 241.7MG/14.5ML (16.67MG, 16.67MG, 16.67MG/ML)); 002 Rx (483.3MG, 483.3MG, 483.3MG/14.5ML (33.33MG, 33.33MG, 33.33MG/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Oct 14, 2027 | Orphan Designation: Treatment of ebola virus infection Approved Labeled Indication: treatment of infection caused by Zaire ebolavirus in adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Zaire ebolavirus infection Exclusivity Protected Indication: treatment of infection caused by Zaire ebolavirus in adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Zaire ebolavirus infection |
avelumab (Injection) (Intravenous) Bavencio
NDA Applicant: EMD Serono, Inc. BLA No.: 761049 Prod. No.: 001 Rx (200MG/10ML (20MG/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Mar 23, 2024 | Orphan Designation: Treatment of merkel cell carcinoma. Approved Labeled Indication: Treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma Exclusivity Protected Indication: Treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma |
axicabtagene ciloleucel (Injection) (Intravenous) Yescarta
NDA Applicant: Kite Pharma Inc. BLA No.: 125643 Prod. No.: 001 Rx (2 _ 10^6 CAR-POSITIVE VIABLE T CELLS PER KG OF BODY WEIGHT)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Oct 18, 2024 | Orphan Designation: Treatment of primary mediastinal B-cell lymphoma. Approved Labeled Indication: Treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma Exclusivity Protected Indication: Treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy, treatment of adult patients with relapsed or refractory DLBCL arising from follicular lymphoma after two or more lines of systemic therapy, and treatment of adult patients with relapsed or refractory primary mediastinal B-cell lymphoma after two or more lines of systemic therapy (not including treatment of patients with primary central nervous system lymphoma) |
| Exclusivity Type: Orphan Drug Exclusivity | Oct 18, 2024 | Orphan Designation: Treatment of diffuse large B-cell lymphoma Approved Labeled Indication: Treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma Exclusivity Protected Indication: Treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy, treatment of adult patients with relapsed or refractory DLBCL arising from follicular lymphoma after two or more lines of systemic therapy, and treatment of adult patients with relapsed or refractory primary mediastinal B-cell lymphoma after two or more lines of systemic therapy (not including treatment of patients with primary central nervous system lymphoma) |
| Exclusivity Type: Orphan Drug Exclusivity | Oct 18, 2024 | Orphan Designation: Treatment of follicular lymphoma. Approved Labeled Indication: Treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma Exclusivity Protected Indication: Treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy, treatment of adult patients with relapsed or refractory DLBCL arising from follicular lymphoma after two or more lines of systemic therapy, and treatment of adult patients with relapsed or refractory primary mediastinal B-cell lymphoma after two or more lines of systemic therapy (not including treatment of patients with primary central nervous system lymphoma) |
| Exclusivity Type: Orphan Drug Exclusivity | Mar 5, 2028 | Orphan Designation: Treatment of follicular lymphoma. Approved Labeled Indication: Treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy Exclusivity Protected Indication: Treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy, excluding patients with diffuse large B-cell lymphoma arising from follicular lymphoma. |
| Exclusivity Type: Orphan Drug Exclusivity | Apr 1, 2029 | Orphan Designation: Treatment of follicular lymphoma. Approved Labeled Indication: Treatment of adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. Limitations of Use: Yescarta is not indicated for the treatment of patients with primary central nervous system lymphoma. Exclusivity Protected Indication: treatment of adult patients with diffuse large B-cell lymphoma (DLBCL) that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy, treatment of adult patients with DLBCL arising from follicular lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy, and treatment of adult patients with primary mediastinal B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy (not including treatment of patients with primary central nervous system lymphoma and excluding patients covered by the indication that received marketing approval on October 18, 2017 for Yescarta) |
| Exclusivity Type: Orphan Drug Exclusivity | Apr 1, 2029 | Orphan Designation: Treatment of diffuse large B-cell lymphoma Approved Labeled Indication: Treatment of adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. Limitations of Use: Yescarta is not indicated for the treatment of patients with primary central nervous system lymphoma. Exclusivity Protected Indication: treatment of adult patients with diffuse large B-cell lymphoma (DLBCL) that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy, treatment of adult patients with DLBCL arising from follicular lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy, and treatment of adult patients with primary mediastinal B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy (not including treatment of patients with primary central nervous system lymphoma and excluding patients covered by the indication that received marketing approval on October 18, 2017 for Yescarta) |
| Exclusivity Type: Orphan Drug Exclusivity | Apr 1, 2029 | Orphan Designation: Treatment of primary mediastinal B-cell lymphoma. Approved Labeled Indication: Treatment of adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. Limitations of Use: Yescarta is not indicated for the treatment of patients with primary central nervous system lymphoma. Exclusivity Protected Indication: treatment of adult patients with diffuse large B-cell lymphoma (DLBCL) that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy, treatment of adult patients with DLBCL arising from follicular lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy, and treatment of adult patients with primary mediastinal B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy (not including treatment of patients with primary central nervous system lymphoma and excluding patients covered by the indication that received marketing approval on October 18, 2017 for Yescarta) |