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.
| 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. |
AbbVie Inc.
Survanta (Suspension) (Intratracheal) beractant
NDA Applicant: AbbVie Inc. BLA No.: 020032 Prod. No.: 001 Rx (100MG/4ML (25MG/ML)); 002 Rx (200MG/8ML (25MG/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Jul 2, 1998 | 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. |
Ablynx NV
Cablivi (For injection) (Intravenous, Subcutaneous ) caplacizumab-yhdp
NDA Applicant: Ablynx NV BLA No.: 761112 Prod. No.: 001 Rx (11MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Feb 6, 2026 | Orphan Designation: Treatment of thrombotic thrombocytopenic purpura Approved Labeled Indication: CABLIVI is indicated for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura (aTTP), in combination with plasma exchange and immunosuppressive therapy. Exclusivity Protected Indication: CABLIVI is indicated for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura (aTTP), in combination with plasma exchange and immunosuppressive therapy. |
Acrotech Biopharma Inc.
Zevalin (Injection) (Intravenous) ibritumomab tiuxetan
NDA Applicant: Acrotech Biopharma Inc. BLA No.: 125019 Prod. No.: 001 Rx (3.2MG/2ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Feb 19, 2009 | Orphan Designation: Treatment of B-cell non-Hodgkin's lymphoma. Approved Labeled Indication: Treatment of patients with relapsed or refractory low-grade, follicular, or transformed B-cell non-Hodgkin's lymphoma, including patients with Rituximab (Rituxan?) refractory follicular non-Hodgkin?s lymphoma |
ADC Therapeutics SA
Zynlonta (For Injection) (Intravenous) loncastuximab tesirine-lpyl
NDA Applicant: ADC Therapeutics SA BLA No.: 761196 Prod. No.: 001 Rx (10MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Apr 23, 2028 | 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, DLBCL arising from low grade lymphoma, and high-grade B-cell lymphoma Exclusivity Protected Indication: treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy |
ADMA Biologics, Inc.
Bivigam (Injection) (Intravenous) Immune Globulin Intravenous (Human)
NDA Applicant: ADMA Biologics, Inc. BLA No.: 125389 Prod. No.: 001 Rx (5GM/50ML) BLA No.: 125389 Prod. No.: 002 Disc (10GM/100ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 11548932 Anti-VEGF protein compositions and methods for producing the same Claim Types: Process Pat. Sub. Date(s): None | Aug 18, 2040 |
Alexion Pharmaceuticals, Inc.
Kanuma (Injection) (Intravenous) sebelipase alfa
NDA Applicant: Alexion Pharmaceuticals, Inc. BLA No.: 125561 Prod. No.: 001 Rx (20MG/10ML (2MG/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Dec 8, 2022 | Orphan Designation: Treatment of lysosomal acid lipase deficiency Approved Labeled Indication: Indicated for the treatment of patients with a diagnosis of Lysosomal Acid Lipase (LAL) deficiency Exclusivity Protected Indication: Indicated for the treatment of patients with a diagnosis of Lysosomal Acid Lipase (LAL) deficiency |
Alexion Pharmaceuticals, Inc.
Soliris (Injection) (Intravenous) eculizumab
NDA Applicant: Alexion Pharmaceuticals, Inc. BLA No.: 125166 Prod. No.: 001 Rx (300MG/30ML (10MG/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Mar 16, 2014 | Orphan Designation: Treatment of paroxysmal nocturnal hemoglobinuria Approved Labeled Indication: Treatment of paroxysmal nocturnal hemoglobinuria to reduce hemolysis |
| Exclusivity Type: Orphan Drug Exclusivity | Sep 23, 2018 | Orphan Designation: Treatment of atypical hemolytic uremic syndrome Approved Labeled Indication: For the treatment of atypical Hemolytic Uremic Syndrome (aHUS) |
| Exclusivity Type: Orphan Drug Exclusivity | Oct 23, 2024 | Orphan Designation: Treatment of Myasthenia Gravis Approved Labeled Indication: for the treatment of adult patients with generalized Myasthenia Gravis (gMG) who are anti-acetylcholine receptor (AchR) antibody positive Exclusivity Protected Indication: for the treatment of adult patients with generalized Myasthenia Gravis (gMG) who are anti-acetylcholine receptor (AchR) antibody positive |
| Exclusivity Type: Orphan Drug Exclusivity | Jun 27, 2026 | Orphan Designation: Treatment of neuromyelitis optica Approved Labeled Indication: Soliris is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. Exclusivity Protected Indication: For the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive |
Alexion Pharmaceuticals, Inc.
Strensiq (Injection) (Subcutaneous) asfotase alfa
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) |
Alexion Pharmaceuticals, Inc.
Ultomiris (Injection) (Intravenous; Subcutaneous) ravulizumab-cwvz
NDA Applicant: Alexion Pharmaceuticals, Inc. BLA No.: 761108 Prod. No.: 001 Rx (300MG/30ML (10MG/ML)); 002 Rx (300MG/3ML (100MG/ML)); 003 Rx (1,100MG/11ML (100MG/ML)); 004 Rx (245MG/3.5ML (70MG/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Dec 21, 2025 | Orphan Designation: Treatment of paroxysmal nocturnal hemoglobinuria Approved Labeled Indication: ULTOMIRIS is indicated for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH). Exclusivity Protected Indication: ULTOMIRIS is indicated for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH). |
| Exclusivity Type: Orphan Drug Exclusivity | Jun 7, 2028 | Orphan Designation: Treatment of paroxysmal nocturnal hemoglobinuria Approved Labeled Indication: Treatment of adult and pediatric patients one month of age and older with paroxysmal nocturnal hemoglobinuria (PNH) Exclusivity Protected Indication: Treatment of pediatric patients one month of age and older with paroxysmal nocturnal hemoglobinuria (PNH) |
Allergan, Inc.
Botox Cosmetic (For Injection) (Intramuscular; Injection, Intramuscular, Intradermal, Intradetrusor) onabotulinumtoxinA
NDA Applicant: Allergan, Inc. BLA No.: 103000 Prod. No.: 001 Rx (50UNITS); 002 Rx (100UNITS); 004 Rx (100UNITS); 005 Rx (200UNITS) BLA No.: 103000 Prod. No.: 003 Disc (50UNITS)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Jun 20, 2026 | 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. |
Amgen Inc.
Blincyto (For Injection) (Intravenous) blinatumomab
NDA Applicant: Amgen Inc. BLA No.: 125557 Prod. No.: 001 Rx (35MCG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Dec 3, 2021 | Orphan Designation: Treatment of acute lymphocytic leukemia Approved Labeled Indication: Treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). Exclusivity Protected Indication: Treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). |
| Exclusivity Type: Orphan Drug Exclusivity | Aug 30, 2023 | Orphan Designation: Treatment of acute lymphocytic leukemia Approved Labeled Indication: treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) Exclusivity Protected Indication: treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) in patients weighing less than 45 kg |
| Exclusivity Type: Orphan Drug Exclusivity | Jul 11, 2024 | Orphan Designation: Treatment of acute lymphocytic leukemia Approved Labeled Indication: treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) in adults and children Exclusivity Protected Indication: treatment of Philadelphia chromosome-positive relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) in adults and children |
| Exclusivity Type: Orphan Drug Exclusivity | Mar 29, 2025 | Orphan Designation: Treatment of acute lymphocytic leukemia Approved Labeled Indication: BLINCYTO is indicated for the treatment of B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1% in adults and children. Exclusivity Protected Indication: For the treatment of B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1% in adults and children |
Amgen Inc.
Epogen/Procrit (Injection) (Intravenous, Subcutaneous ) epoetin alfa
NDA Applicant: Amgen Inc. BLA No.: 103234 Prod. No.: 001 Rx (10,000UNITS/ML); 002 Rx (20,000UNITS/2ML (10,000UNITS/ML)); 003 Rx (20,000UNITS/ML); 004 Rx (2,000UNITS/ML); 005 Rx (3,000UNITS/ML); 006 Rx (40,000UNITS/ML); 007 Rx (4,000UNITS/ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Dec 31, 1997 | 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. |
Amgen Inc.
Imlygic (For Injection) (Intralesional) Talimogene laherparepvec
NDA Applicant: Amgen Inc. BLA No.: 125518 Prod. No.: 001 Rx (100 MILLION PFU/ML); 002 Rx (1 MILLION PFU/ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Oct 27, 2022 | Orphan Designation: Treatment of stage IIb-stage IV melanoma Approved Labeled Indication: Indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery Exclusivity Protected Indication: Indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery |
Amgen Inc.
Neulasta; Neulasta Onpro (Injection) (Subcutaneous) pegfilgrastim
NDA Applicant: Amgen Inc. BLA No.: 125031 Prod. No.: 001 Rx (6MG/0.6ML); 002 Rx (6MG/0.6ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9856287 Refolding proteins using a chemically controlled redox state Claim Types: Process Pat. Sub. Date(s): None | Jun 21, 2030 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Type: Orphan Drug Exclusivity | Nov 13, 2022 | Orphan Designation: Treatment of subjects at risk of developing myelosuppression after a radiological or nuclear incident Approved Labeled Indication: To increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome) Exclusivity Protected Indication: To increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome) |
Amgen Inc.
Neupogen (Injection) (Intravenous, Subcutaneous ) filgrastim
NDA Applicant: Amgen Inc. BLA No.: 103353 Prod. No.: 001 Rx (300MCG/ML); 002 Rx (480MCG/1.6ML); 003 Rx (300MCG/0.5ML); 004 Rx (480MCG/0.8ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Jun 15, 2001 | Orphan Designation: Treatment of neutropenia associated with bone marrow transplants. Approved Labeled Indication: Reduce the duration of neutropenia and neutropenia sequelae in patients with non-myeloid malignancies undergoing ablative chemotherapy followed by BMT. |
| Exclusivity Type: Orphan Drug Exclusivity | Dec 19, 2001 | Orphan Designation: Treatment of patients with severe chronic neutropenia (absolute neutrophil count less than 500/mm3). Approved Labeled Indication: Treatment of patients with severe chronic neutropenia. |
| Exclusivity Type: Orphan Drug Exclusivity | Dec 28, 2002 | Orphan Designation: For use in the mobilization of peripheral blood progenitor cells for collection in patients who will receive myeloablative or myelosuppressive chemotherapy. Approved Labeled Indication: For use in the mobilization of hematopoietic progenitor cells into the peripheral blood collection by leukapheresis. |
| Exclusivity Type: Orphan Drug Exclusivity | Apr 2, 2005 | Orphan Designation: Reduction in the duration of neutropenia, fever, antibiotic use, and hospitalization, following induction and consolidation treatment for acute myeloid leukemia. Approved Labeled Indication: Reducing the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of adults with acute myeloid leukemia. |
| Exclusivity Type: Orphan Drug Exclusivity | Mar 30, 2022 | Orphan Designation: Treatment of subjects at risk of developing myelosuppression after a radiological or nuclear incident Approved Labeled Indication: To increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome). Exclusivity Protected Indication: To increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome). |
Amgen Inc.
Nplate (For Injection) (Subcutaneous) romiplostim
NDA Applicant: Amgen Inc. BLA No.: 125268 Prod. No.: 001 Rx (250MCG); 002 Rx (500MCG); 003 Rx (125MCG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Aug 22, 2015 | Orphan Designation: Treatment of immune thrombocytopenic purpura Approved Labeled Indication: Treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy |
| Exclusivity Type: Orphan Drug Exclusivity | Dec 14, 2025 | Orphan Designation: Treatment of immune thrombocytopenic purpura Approved Labeled Indication: Nplate is indicated for the treatment of thrombocytopenia in pediatric patients 1 year of age and older with ITP for at least 6 months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Exclusivity Protected Indication: Nplate is indicated for the treatment of pediatric patients 1 year of age and older with immune thrombocytopenia (ITP) for at least 6 months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. |
| Exclusivity Type: Orphan Drug Exclusivity | Oct 17, 2026 | Orphan Designation: Treatment of immune thrombocytopenic purpura Approved Labeled Indication: Nplate is indicated for the treatment of thrombocytopenia in adult patients with immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy Exclusivity Protected Indication: For the treatment of thrombocytopenia in adult patients with non-chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. |
| Exclusivity Type: Orphan Drug Exclusivity | Jan 28, 2028 | Orphan Designation: Treatment of patients acutely exposed to myelosuppressive doses of radiation following radiological/nuclear incident Approved Labeled Indication: to increase survival in adults and pediatric patients (including term neonates) acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome [HS-ARS]) Exclusivity Protected Indication: to increase survival in adults and pediatric patients (including term neonates) acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome [HS-ARS]) |
Amgen Inc.
Prolia (Injection) (Subcutaneous) denosumab
NDA Applicant: Amgen Inc. BLA No.: 125320 Prod. No.: 001 Rx (60MG/ML) BLA No.: 125320 Prod. No.: 002 Disc (60MG/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7364736 Antibodies to OPGL Claim Types: Compound; Composition Pat. Sub. Date(s): None | Feb 19, 2025 | |
| Pat. No. 7427659 Process for purifying proteins in a hydrophobic interaction chromatography flow-through fraction Claim Types: Process Pat. Sub. Date(s): None | Mar 15, 2025 | |
| Pat. No. 7928205 Methods for refolding of recombinant antibodies Claim Types: Process Pat. Sub. Date(s): None | Feb 12, 2027 | |
| Pat. No. 8058418 Polynucleotides encoding heavy and light chains of antibodies to OPGL Claim Types: Formulation Pat. Sub. Date(s): None | Nov 30, 2023 | |
| Pat. No. 9012178 Dipeptides to enhance yield and viability from cell cultures Claim Types: Process; Cell culture Pat. Sub. Date(s): None | Aug 5, 2031 | |
| Pat. No. 9133493 Method for culturing mammalian cells to improve recombinant protein production Claim Types: Process Pat. Sub. Date(s): None | Apr 20, 2032 | |
| Pat. No. 9228168 Feed media Claim Types: Process; Cell culture medium Pat. Sub. Date(s): None | Jan 19, 2030 | |
| Pat. No. 9320816 Methods of treating cell culture media for use in a bioreactor Claim Types: Process Pat. Sub. Date(s): None | Nov 14, 2030 | |
| Pat. No. 9328134 Carbohydrate phosphonate derivatives as modulators of glycosylation Claim Types: Compound; Process Pat. Sub. Date(s): None | Feb 20, 2034 | |
| Pat. No. 9359435 Methods for modulating mannose content of recombinant proteins Claim Types: Process Pat. Sub. Date(s): None | May 22, 2027 | |
| Pat. No. 9388447 Method for culturing mammalian cells to improve recombinant protein production Claim Types: Process Pat. Sub. Date(s): None | Apr 20, 2032 | |
| Pat. No. 9481901 Methods for increasing mannose content of recombinant proteins Claim Types: Process Pat. Sub. Date(s): None | May 29, 2034 | |
| Pat. No. 10167492 Process for manipulating the level of glycan content of a glycoprotein Claim Types: Process Pat. Sub. Date(s): None | Dec 1, 2035 | |
| Pat. No. 10513723 Decreasing ornithine production to decrease high mannose glycoform content of recombinant proteins Claim Types: Process Pat. Sub. Date(s): None | Dec 9, 2034 | |
| Pat. No. 10583397 Process control systems and methods for use with filters and filtration processes Claim Types: Device Pat. Sub. Date(s): None | Jul 28, 2035 | |
| Pat. No. 10822630 Process for manipulating the level of glycan content of a glycoprotein Claim Types: Process Pat. Sub. Date(s): None | Dec 1, 2035 | |
| Pat. No. 10894972 Methods for increasing mannose content of recombinant proteins Claim Types: Cell culture medium; Process Pat. Sub. Date(s): None | May 29, 2034 | |
| Pat. No. 11077404 Process control systems and methods for use with filters and filtration processes Claim Types: Device; Process Pat. Sub. Date(s): None | May 13, 2035 | |
| Pat. No. 11098079 Charged depth filtration of antigen-binding proteins Claim Types: Process Pat. Sub. Date(s): None | Jul 21, 2037 | |
| Pat. No. 11130980 Use of monensin to regulate glycosylation of recombinant proteins Claim Types: Process Pat. Sub. Date(s): None | Apr 5, 2035 | |
| Pat. No. 11254963 Increasing ornithine accumulation to increase high mannose glycoform content of recombinant proteins Claim Types: Process Pat. Sub. Date(s): None | Dec 9, 2034 | |
| Pat. No. 11299760 Use of monensin to regulate glycosylation of recombinant proteins Claim Types: Process Pat. Sub. Date(s): None | Oct 30, 2034 | |
| Pat. No. 11434514 Methods for increasing mannose content of recombinant proteins Claim Types: Process Pat. Sub. Date(s): None | May 29, 2034 |
Amgen Inc.
Repatha (Injection) (Subcutaneous) evolocumab
NDA Applicant: Amgen Inc. BLA No.: 125522 Prod. No.: 001 Rx (140MG/ML); 002 Rx (140MG/ML); 003 Rx (420MG/3.5ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Aug 27, 2022 | Orphan Designation: Treatment of homozygous familial hypercholesterolemia Approved Labeled Indication: As an adjunct to diet and other LDL-lowering therapies (e.g., statins, ezetimibe, LDL apheresis) in patients with HoFH who require additional lowering of LDL-C. Exclusivity Protected Indication: As an adjunct to diet and other LDL-lowering therapies (e.g., statins, ezetimibe, LDL apheresis) in patients with HoFH who require additional lowering of LDL-C. |
| Exclusivity Type: Orphan Drug Exclusivity | Sep 24, 2028 | Orphan Designation: Treatment of homozygous familial hypercholesterolemia Approved Labeled Indication: As an adjunct to other low-density lipoprotein cholesterol (LDL-C)-lowering therapies in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH), to reduce LDL-C Exclusivity Protected Indication: to reduce LDL-C in pediatric patients aged 10 to less than 13 years with homozygous familial hypercholesterolemia (HoFH) |
Amgen Inc.
Xgeva (Injection) (Subcutaneous) denosumab
NDA Applicant: Amgen Inc. BLA No.: 125320 Prod. No.: 003 Rx (120MG/1.7ML (70MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7364736 Antibodies to OPGL Claim Types: Compound; Composition Pat. Sub. Date(s): None | Feb 19, 2025 | |
| Pat. No. 7427659 Process for purifying proteins in a hydrophobic interaction chromatography flow-through fraction Claim Types: Process Pat. Sub. Date(s): None | Mar 15, 2025 | |
| Pat. No. 7928205 Methods for refolding of recombinant antibodies Claim Types: Process Pat. Sub. Date(s): None | Feb 12, 2027 | |
| Pat. No. 8058418 Polynucleotides encoding heavy and light chains of antibodies to OPGL Claim Types: Formulation Pat. Sub. Date(s): None | Nov 30, 2023 | |
| Pat. No. 9012178 Dipeptides to enhance yield and viability from cell cultures Claim Types: Process; Cell culture Pat. Sub. Date(s): None | Aug 5, 2031 | |
| Pat. No. 9133493 Method for culturing mammalian cells to improve recombinant protein production Claim Types: Process Pat. Sub. Date(s): None | Apr 20, 2032 | |
| Pat. No. 9228168 Feed media Claim Types: Process; Cell culture medium Pat. Sub. Date(s): None | Jan 19, 2030 | |
| Pat. No. 9320816 Methods of treating cell culture media for use in a bioreactor Claim Types: Process Pat. Sub. Date(s): None | Nov 14, 2030 | |
| Pat. No. 9328134 Carbohydrate phosphonate derivatives as modulators of glycosylation Claim Types: Compound; Process Pat. Sub. Date(s): None | Feb 20, 2034 | |
| Pat. No. 9359435 Methods for modulating mannose content of recombinant proteins Claim Types: Process Pat. Sub. Date(s): None | May 22, 2027 | |
| Pat. No. 9388447 Method for culturing mammalian cells to improve recombinant protein production Claim Types: Process Pat. Sub. Date(s): None | Apr 20, 2032 | |
| Pat. No. 9481901 Methods for increasing mannose content of recombinant proteins Claim Types: Process Pat. Sub. Date(s): None | May 29, 2034 | |
| Pat. No. 10167492 Process for manipulating the level of glycan content of a glycoprotein Claim Types: Process Pat. Sub. Date(s): None | Dec 1, 2035 | |
| Pat. No. 10513723 Decreasing ornithine production to decrease high mannose glycoform content of recombinant proteins Claim Types: Process Pat. Sub. Date(s): None | Dec 9, 2034 | |
| Pat. No. 10583397 Process control systems and methods for use with filters and filtration processes Claim Types: Device Pat. Sub. Date(s): None | Jul 28, 2035 | |
| Pat. No. 10822630 Process for manipulating the level of glycan content of a glycoprotein Claim Types: Process Pat. Sub. Date(s): None | Dec 1, 2035 | |
| Pat. No. 10894972 Methods for increasing mannose content of recombinant proteins Claim Types: Cell culture medium; Process Pat. Sub. Date(s): None | May 29, 2034 | |
| Pat. No. 11077404 Process control systems and methods for use with filters and filtration processes Claim Types: Device; Process Pat. Sub. Date(s): None | May 13, 2035 | |
| Pat. No. 11098079 Charged depth filtration of antigen-binding proteins Claim Types: Process Pat. Sub. Date(s): None | Jul 21, 2037 | |
| Pat. No. 11130980 Use of monensin to regulate glycosylation of recombinant proteins Claim Types: Process Pat. Sub. Date(s): None | Apr 5, 2035 | |
| Pat. No. 11254963 Increasing ornithine accumulation to increase high mannose glycoform content of recombinant proteins Claim Types: Process Pat. Sub. Date(s): None | Dec 9, 2034 | |
| Pat. No. 11299760 Use of monensin to regulate glycosylation of recombinant proteins Claim Types: Process Pat. Sub. Date(s): None | Oct 30, 2034 | |
| Pat. No. 11434514 Methods for increasing mannose content of recombinant proteins Claim Types: Process Pat. Sub. Date(s): None | May 29, 2034 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Type: Orphan Drug Exclusivity | Jun 13, 2020 | Orphan Designation: Treatment of patients with giant cell tumor of bone Approved Labeled Indication: Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity. Exclusivity Protected Indication: Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity. |
| Exclusivity Type: Orphan Drug Exclusivity | Dec 5, 2021 | Orphan Designation: Treatment of hypercalcemia in malignancy Approved Labeled Indication: To treat hypercalcemia of malignancy refractory to biphosphonate therapy. Exclusivity Protected Indication: To treat hypercalcemia of malignancy refractory to biphosphonate therapy. |
Amryt Pharmaceuticals DAC
Myalept (For Injection) (Subcutaneous) metreleptin
NDA Applicant: Amryt Pharmaceuticals DAC BLA No.: 125390 Prod. No.: 001 Rx (11.3MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 11555176 Cell culture medium for eukaryotic cells Claim Types: Process Pat. Sub. Date(s): None | Jan 27, 2040 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Type: Orphan Drug Exclusivity | Feb 24, 2021 | Orphan Designation: Treatment of metabolic disorders secondary to lipodystrophy Approved Labeled Indication: Adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy. Exclusivity Protected Indication: Adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy. |
Argenx BV
Vyvgart (Injection) (Intravenous) efgartigimod alfa-fcab
NDA Applicant: Argenx BV BLA No.: 761195 Prod. No.: 001 Rx (400MG/20ML (20MG/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Dec 17, 2028 | Orphan Designation: Treatment of myasthenia gravis Approved Labeled Indication: treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive Exclusivity Protected Indication: treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive |
Argenx BV
Vyvgart Hytrulo (Injection) (Subcutaneous) efgartigimod alfa and hyaluronidase-qvfc
NDA Applicant: Argenx BV BLA No.: 761304 Prod. No.: 001 Rx (1,008MG/5.6ML; 11,200UNITS/5.6ML (180MG/2,000UNITS/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Jun 20, 2030 | Orphan Designation: Treatment of myasthenia gravis Approved Labeled Indication: treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive Exclusivity Protected Indication: treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive |
AstraZeneca AB
Andexxa (Injection) (Intravenous) Coagulation Factor Xa (Recombinant), Inactivated-zhzo
NDA Applicant: AstraZeneca AB BLA No.: 125586 Prod. No.: 001 Rx (100MG); 002 Rx (200MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | May 3, 2025 | Orphan Designation: For reversing the anticoagulant effect of direct or indirect factor Xa inhibitors in patients experiencing a serious uncontrolled bleeding event or who require urgent or emergent surgery Approved Labeled Indication: Coagulation factor Xa (recombinant), inactivated-zhzo is indicated for patients treated with rivaroxaban and apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding Exclusivity Protected Indication: Coagulation factor Xa (recombinant), inactivated-zhzo is indicated for patients treated with rivaroxaban and apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding |
AstraZeneca AB
Imjudo (Injection) (Intravenous) tremelimumab-actl
NDA Applicant: AstraZeneca AB BLA No.: 761289 Prod. No.: 001 Rx (25MG/1.25ML (20MG/ML)); 002 Rx (300MG/15ML (20MG/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Oct 21, 2029 | Orphan Designation: Treatment of hepatocellular carcinoma Approved Labeled Indication: In combination with durvalumab for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC) Exclusivity Protected Indication: treatment of adult patients with unresectable hepatocellular carcinoma (uHCC) |
AstraZeneca UK Ltd
Imfinzi (Injection) (Intravenous) durvalumab
NDA Applicant: AstraZeneca UK Ltd BLA No.: 761069 Prod. No.: 001 Rx (500MG/10ML (50MG/ML)); 002 Rx (120MG/2.4ML (50MG/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Mar 27, 2027 | Orphan Designation: Treatment of small cell lung cancer Approved Labeled Indication: IMFINZI is indicated for use, in combination with etoposide and either carboplatin or cisplatin, for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). Exclusivity Protected Indication: Indicated in combination with etoposide and either carboplatin or cisplatin, for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). |
| Exclusivity Type: Orphan Drug Exclusivity | Sep 2, 2029 | Orphan Designation: Treatment of biliary tract cancer Approved Labeled Indication: In combination with gemcitabine and cisplatin, for the treatment of adult patients with locally advanced or metastatic biliary tract cancer (BTC) Exclusivity Protected Indication: treatment of adult patients with locally advanced or metastatic biliary tract cancer (BTC) |
| Exclusivity Type: Orphan Drug Exclusivity | Oct 21, 2029 | Orphan Designation: Treatment of hepatocellular carcinoma Approved Labeled Indication: In combination with tremelimumab-actl for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC) Exclusivity Protected Indication: treatment of adult patients with unresectable hepatocellular carcinoma (uHCC) |
Auxilium Pharmaceuticals, Inc.
Xiaflex (For Injection) (Intralesional) collagenase clostridium histolyticum
NDA Applicant: Auxilium Pharmaceuticals, Inc. BLA No.: 125338 Prod. No.: 001 Rx (0.9MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Feb 2, 2017 | Orphan Designation: Treatment of advanced (involutional or residual stage) Dupuytren's disease Approved Labeled Indication: Treatment of adult patients with Dupuytren's contracture with a palpable cord |
| Exclusivity Type: Orphan Drug Exclusivity | Dec 6, 2020 | Orphan Designation: Treatment of Peyronie's disease. Approved Labeled Indication: Treatment of adult men with Peyronie's disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy. Exclusivity Protected Indication: Treatment of adult men with Peyronie's disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy. |