Company 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.


AbbVie Inc.
Humira (Injection) (Subcutaneous) adalimumab
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.

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))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJul 2, 1998Orphan 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)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityFeb 6, 2026Orphan 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 LLC
Zevalin (Injection) (Intravenous) ibritumomab tiuxetan
Drug Classes: CD20-directed radiotherapeutic antibody
NDA Applicant: Acrotech Biopharma LLC      BLA No.: 125019  Prod. No.: 001 Rx (3.2MG/2ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityFeb 19, 2009Orphan 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)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityApr 23, 2028Orphan 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

Alexion Pharmaceuticals, Inc.
Kanuma (Injection) (Intravenous) sebelipase alfa
Drug Classes: Genetic, Enzyme, or Protein Disorder: Replacement, Modifiers, Treatment == hydrolytic lysosomal cholesteryl ester-specific enzyme == hydrolytic lysosomal triacylglycerol-specific enzyme
NDA Applicant: Alexion Pharmaceuticals, Inc.      BLA No.: 125561  Prod. No.: 001 Rx (20MG/10ML (2MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityDec 8, 2022Orphan 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
Drug Classes: Immunological Agents:Immunological Agents, Other == complement inhibitor
NDA Applicant: Alexion Pharmaceuticals, Inc.      BLA No.: 125166  Prod. No.: 001 Rx (300MG/30ML (10MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMar 16, 2014Orphan Designation: Treatment of paroxysmal nocturnal hemoglobinuria
Approved Labeled Indication: Treatment of paroxysmal nocturnal hemoglobinuria to reduce hemolysis
Exclusivity Type: Orphan Drug ExclusivitySep 23, 2018Orphan Designation: Treatment of atypical hemolytic uremic syndrome
Approved Labeled Indication: For the treatment of atypical Hemolytic Uremic Syndrome (aHUS)
Exclusivity Type: Orphan Drug ExclusivityOct 23, 2024Orphan 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 ExclusivityJun 27, 2026Orphan 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
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)

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))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityDec 21, 2025Orphan 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 ExclusivityJun 7, 2028Orphan 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
Drug Classes: Dermatological Agents:Dermatological Agents, Other
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)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJun 20, 2026Orphan 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
Drug Classes: Antineoplastics:Monoclonal Antibody/Antibody-Drug Conjugate == bispecific CD19-directed CD3 T-cell engager
NDA Applicant: Amgen, Inc.      BLA No.: 125557  Prod. No.: 001 Rx (35MCG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityDec 3, 2021Orphan 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 ExclusivityAug 30, 2023Orphan 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 ExclusivityJul 11, 2024Orphan 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 ExclusivityMar 29, 2025Orphan 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
Drug Classes: Blood Products and Modifiers:Blood Products and Modifiers, Other
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)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityDec 31, 1997Orphan 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)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityOct 27, 2022Orphan 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
Drug Classes: leukocyte growth factor
NDA Applicant: Amgen, Inc.      BLA No.: 125031  Prod. No.: 001 Rx (6MG/0.6ML); 002 Rx (6MG/0.6ML)
PatentsExpirationPatented Use
Pat. No. 9856287 Refolding proteins using a chemically controlled redox state
Claim Types: Process
Pat. Sub. Date(s): None
Jun 21, 2030 
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityNov 13, 2022Orphan 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
Drug Classes: Immunological Agents:Immunostimulants == leukocyte growth factor
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)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJun 15, 2001Orphan 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 ExclusivityDec 19, 2001Orphan 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 ExclusivityDec 28, 2002Orphan 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 ExclusivityApr 2, 2005Orphan 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 ExclusivityMar 30, 2022Orphan 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
Drug Classes: Blood Products and Modifiers:Blood Products and Modifiers, Other
NDA Applicant: Amgen, Inc.      BLA No.: 125268  Prod. No.: 001 Rx (250MCG); 002 Rx (500MCG); 003 Rx (125MCG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityAug 22, 2015Orphan 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 ExclusivityDec 14, 2025Orphan 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 ExclusivityOct 17, 2026Orphan 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 ExclusivityJan 28, 2028Orphan 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.
Repatha (Injection) (Subcutaneous) evolocumab
Drug Classes: Cardiovascular Agents:Dyslipidemics, PCSK9 Inhibitor == PCSK9 (Proprotein Convertase Subtilisin Kexin Type 9) inhibitor
NDA Applicant: Amgen, Inc.      BLA No.: 125522  Prod. No.: 001 Rx (140MG/ML); 002 Rx (140MG/ML); 003 Rx (420MG/3.5ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityAug 27, 2022Orphan 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 ExclusivitySep 24, 2028Orphan 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
Drug Classes: Metabolic Bone Disease Agents == RANK ligand (RANKL) inhibitor
NDA Applicant: Amgen, Inc.      BLA No.: 125320  Prod. No.: 003 Rx (120MG/1.7ML (70MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJun 13, 2020Orphan 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 ExclusivityDec 5, 2021Orphan 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
Drug Classes: Gastrointestinal Agents:Gastrointestinal Agents, Other == leptin analog
NDA Applicant: Amryt Pharmaceuticals DAC      BLA No.: 125390  Prod. No.: 001 Rx (11.3MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityFeb 24, 2021Orphan 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.

AstraZeneca AB
Andexxa (Injection) (Intravenous) Coagulation Factor Xa (Recombinant), Inactivated-zhzo
Drug Classes: Blood Products and Modifiers:Blood Component Deficiency/ Replacement == human blood coagulation factor ==
NDA Applicant: AstraZeneca AB      BLA No.: 125586  Prod. No.: 001 Rx (100MG); 002 Rx (200MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMay 3, 2025Orphan 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 UK Ltd
Imfinzi (Injection) (Intravenous) durvalumab
Drug Classes: Antineoplastics:Monoclonal Antibody/Antibody-Drug Conjugate == programmed death ligand-1 (PD-L1) blocking antibody
NDA Applicant: AstraZeneca UK Ltd      BLA No.: 761069  Prod. No.: 001 Rx (500MG/10ML (50MG/ML)); 002 Rx (120MG/2.4ML (50MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMar 27, 2027Orphan 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).

Auxilium Pharmaceuticals, Inc.
Xiaflex (For Injection) (Intralesional) collagenase clostridium histolyticum
Drug Classes: Dermatological Agents:Dermatological Agents, Other == collagen-specific enzyme
NDA Applicant: Auxilium Pharmaceuticals, Inc.      BLA No.: 125338  Prod. No.: 001 Rx (0.9MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityFeb 2, 2017Orphan 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 ExclusivityDec 6, 2020Orphan 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.



Last edited: 15 November 2022
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