Generic names starting with "A"

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.


abobotulinumtoxinA (For Injection) (Intramuscular) Dysport
Drug Classes: Dermatological Agents:Dermatological Agents, Other
NDA Applicant: Ipsen Biopharm Limited      BLA No.: 125274  Prod. No.: 001 Rx (300UNITS); 002 Rx (500UNITS)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJul 29, 2023Orphan 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
Drug Classes: Immunological Agents:Immunosuppressants
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)
PatentsExpirationPatented 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 
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityFeb 21, 2015Orphan 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 ExclusivitySep 23, 2021Orphan 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 ExclusivitySep 30, 2021Orphan 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 ExclusivitySep 9, 2022Orphan 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 ExclusivityJun 30, 2023Orphan 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 ExclusivitySep 28, 2025Orphan 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 ExclusivityOct 16, 2025Orphan 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 ExclusivityFeb 24, 2028Orphan 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)
ExclusivityExpirationExclusivity Description
Exclusivity Type: 1st Interchangeable ExclusivityDate TBD 

aflibercept (Injection) (Intravitreal) Eylea
Drug Classes: Ophthalmic Agents:Ophthalmic Agents, Other
NDA Applicant: Regeneron Pharmaceuticals, Inc.      BLA No.: 125387  Prod. No.: 001 Rx (2MG/0.05ML); 002 Rx (2MG/0.05ML)
PatentsExpirationPatented 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. 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. 10828345 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. 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 

agalsidase beta (For Injection) (Intravenous) Fabrazyme
Drug Classes: Genetic, Enzyme, or Protein Disorder: Replacement, Modifiers, Treatment == hydrolytic lysozomal neutral glycosphingolipid-specific enzyme
NDA Applicant: Genzyme Corporation      BLA No.: 103979  Prod. No.: 001 Rx (35MG); 002 Rx (5MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityApr 24, 2010Orphan 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 ExclusivityMar 11, 2028Orphan 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
Drug Classes: Antineoplastics:Antineoplastics, Other == lymphocyte growth factor
NDA Applicant: Clinigen, Inc.      BLA No.: 103293  Prod. No.: 001 Rx (22MILLION INTERNATIONAL UNITS (1.3MG))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMay 5, 1999Orphan 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 ExclusivityJan 9, 2005Orphan Designation: Treatment of metastatic melanoma.
Approved Labeled Indication: Treatment of adults with metastatic melanoma.

alemtuzumab (Injection) (Intravenous) Campath; Lemtrada
Drug Classes: Central Nervous System Agents:Multiple Sclerosis Agents == CD52-directed cytolytic monoclonal antibody
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))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMay 7, 2008Orphan 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
Drug Classes: Genetic, Enzyme, or Protein Disorder: Replacement, Modifiers, Treatment == hydrolytic lysosomal glycogen-specific enzyme
NDA Applicant: Genzyme Corporation      BLA No.: 125141  Prod. No.: 001 Disc (50MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityApr 28, 2013Orphan 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
Drug Classes: Cardiovascular Agents:Dyslipidemics, PCSK9 Inhibitor == PCSK9 (Proprotein Convertase Subtilisin Kexin Type 9) inhibitor
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)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityApr 1, 2028Orphan 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)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJun 15, 2028Orphan 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)

allogeneic processed thymus tissue-agdc (For Suspension) (Implantation) Rethymic
NDA Applicant: Enzyvant Therapeutics GmbH      BLA No.: 125685  Prod. No.: 001 Rx (SEMI-QUANTITATIVE)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityOct 8, 2028Orphan 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 ExclusivityOct 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)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityDec 2, 1994Orphan 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.

anakinra (Injection) (Subcutaneous) Kineret
Drug Classes: Immunological Agents:Immunological Agents, Other == interleukin-1 (IL-1) receptor antagonist
NDA Applicant: Swedish Orphan Biovitrum AB (publ)      BLA No.: 103950  Prod. No.: 001 Rx (100MG/0.67ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityDec 21, 2019Orphan Designation: Treatment of cryopyrin-associated periodic syndromes
Approved Labeled Indication: Treatment of neonatal-onset multisystem inflammatory disease (NOMID)
Exclusivity Type: Orphan Drug ExclusivityDec 18, 2027Orphan 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: Ridgeback Biotherapeutics      BLA No.: 761172  Prod. No.: 001 Rx (400MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityDec 21, 2027Orphan 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)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMar 24, 2022Orphan 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)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityNov 23, 2022Orphan 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
Drug Classes: Blood Products and Modifiers:Blood Component Deficiency/ Replacement == anti-inhibitory coagulant complex
NDA Applicant: Baxalta US 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)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityDec 16, 2020Orphan 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
Drug Classes: Blood Products and Modifiers:Blood Component Deficiency/ Replacement == human antihemophilic factor
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)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityFeb 25, 2000Orphan 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
Drug Classes: Blood Products and Modifiers:Blood Component Deficiency/ Replacement == human antihemophilic factor
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)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJun 6, 2021Orphan 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), Porcine Sequence (For Injection) (Intravenous) Obizur
Drug Classes: Blood Products and Modifiers:Blood Component Deficiency/ Replacement == human antihemophilic factor
NDA Applicant: Baxalta US Inc.      BLA No.: 125512  Prod. No.: 001 Rx (500U)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityOct 23, 2021Orphan 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
Drug Classes: Blood Products and Modifiers:Blood Component Deficiency/ Replacement == human antihemophilic factor
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)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJan 31, 2014Orphan 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
Drug Classes: Blood Products and Modifiers:Blood Component Deficiency/ Replacement == human antihemophilic factor
NDA Applicant: CSL Behring GmbH      BLA No.: 103960  Prod. No.: 001 Rx (1000IU); 002 Rx (250IU); 003 Rx (500IU)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityApr 1, 2006Orphan 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
Drug Classes: Blood Products and Modifiers:Blood Component Deficiency/ Replacement == recombinant antithrombin
NDA Applicant: rEVO Biologics, Inc.      BLA No.: 125284  Prod. No.: 001 Rx (1750IU); 002 Rx (525IU)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityFeb 6, 2016Orphan 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
Drug Classes: Blood Products and Modifiers:Blood Component Deficiency/ Replacement == recombinant antithrombin
NDA Applicant: Grifols Therapeutics LLC      BLA No.: 103196  Prod. No.: 001 Rx (500IU)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityDec 30, 1998Orphan Designation: For replacement therapy in congenital deficiency of AT-III for prevention and treatment of thrombosis and pulmonary emboli.

aprotinin (Injection) (Intravenous) Trasylol
Drug Classes: antifibrinolytic
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))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityDec 29, 2000Orphan 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
Drug Classes: Genetic, Enzyme, or Protein Disorder: Replacement, Modifiers, Treatment
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)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityOct 23, 2022Orphan 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
Drug Classes: Antineoplastics:Monoclonal Antibody/Antibody-Drug Conjugate == human programmed death receptor-1 (PD-1)-blocking antibody
NDA Applicant: Genentech, Inc.      BLA No.: 761034  Prod. No.: 001 Rx (1200MG/20ML (60MG/ML)); 002 Rx (840MG/14ML (60MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMar 18, 2026Orphan 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 ExclusivityJul 30, 2027Orphan 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

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))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityOct 14, 2027Orphan 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
Drug Classes: Antineoplastics:Monoclonal Antibody/Antibody-Drug Conjugate == programmed death ligand-1 (PD-L1) blocking antibody
NDA Applicant: EMD Serono, Inc.      BLA No.: 761049  Prod. No.: 001 Rx (200MG/10ML (20MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMar 23, 2024Orphan 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
Drug Classes: CD19-directed genetically modified autologous T-cells
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)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityOct 18, 2024Orphan 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 ExclusivityOct 18, 2024Orphan 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 ExclusivityOct 18, 2024Orphan 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 ExclusivityMar 5, 2028Orphan 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.



Last edited: 15 November 2022
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