Tradenames starting with "A"

Patents whose numbers are in italics have been extended under 35 USC 156. All expiration dates include applicable Sec. 156 and pediatric (PED) extensions.


Abecma (Injection) (Intravenous) idecabtagene vicleucel
NDA Applicant: Celgene Corporation, a Bristol-Myers Squibb Company      BLA No.: 125736  Prod. No.: 001 Rx (150 TO 540 X 10^6 CHIMERIC ANTIGEN RECEPTOR (CAR)-POSITIVE T CELLS IN ONE OR MORE INFUSION)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMar 26, 2028Orphan Designation: Treatment of multiple myeloma
Approved Labeled Indication: treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody
Exclusivity Protected Indication: treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody

Actemra (; Injection) (; Intravenous) tocilizumab
Drug Classes: Immunological Agents:Immunological Agents, Other == interleukin-6 (IL-6) receptor antagonist
NDA Applicant: Genentech, Inc.      BLA No.: 125276  Prod. No.: 002 Rx (200MG/10ML (20MG/ML)); 003 Rx (400MG/20ML (20MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityApr 29, 2020Orphan Designation: Treatment of pediatric patients (age 16 years and younger) with polyarticular-course juvenile idiopathic arthritis
Approved Labeled Indication: ACTEMRA_ (tocilizumab) for subcutaneous injection is indicated for the treatment of active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older
Exclusivity Protected Indication: Treatment of active polyarticular juvenile idiopathic arthritis in patients 2 through 16 years of age.
Exclusivity Type: Orphan Drug ExclusivityAug 30, 2024Orphan Designation: Treatment of chimeric antigen receptor (CAR) T cell-induced cytokine release syndrome
Approved Labeled Indication: Treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in adults and pediatric patients 2 years of age and older
Exclusivity Protected Indication: Treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in adults and pediatric patients 2 years of age and older
Exclusivity Type: Orphan Drug ExclusivityMar 4, 2028Orphan Designation: Treatment of systemic sclerosis
Approved Labeled Indication: slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease
Exclusivity Protected Indication: slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease

Actemra (Injection) (Subcutaneous) tocilizumab
Drug Classes: Immunological Agents:Immunological Agents, Other == interleukin-6 (IL-6) receptor antagonist
NDA Applicant: Genentech, Inc.      BLA No.: 125472  Prod. No.: 001 Rx (162MG/0.9ML); 002 Rx (162MG/0.9ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityApr 29, 2020Orphan Designation: Treatment of pediatric patients (age 16 years and younger) with polyarticular-course juvenile idiopathic arthritis
Approved Labeled Indication: ACTEMRA_ (tocilizumab) for subcutaneous injection is indicated for the treatment of active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older
Exclusivity Protected Indication: Treatment of active polyarticular juvenile idiopathic arthritis in patients 2 through 16 years of age.
Exclusivity Type: Orphan Drug ExclusivityAug 30, 2024Orphan Designation: Treatment of chimeric antigen receptor (CAR) T cell-induced cytokine release syndrome
Approved Labeled Indication: Treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in adults and pediatric patients 2 years of age and older
Exclusivity Protected Indication: Treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in adults and pediatric patients 2 years of age and older
Exclusivity Type: Orphan Drug ExclusivityMar 4, 2028Orphan Designation: Treatment of systemic sclerosis
Approved Labeled Indication: slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease
Exclusivity Protected Indication: slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease

Acthrel (For Injection) (Intravenous) corticorelin ovine triflutate
NDA Applicant: Ferring Pharmaceuticals Inc.      BLA No.: 020162  Prod. No.: 001 Disc (100MCG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMay 23, 2003Orphan Designation: For use in differentiating pituitary and ectopic production of ACTH in patients with ACTH-dependent Cushings syndrome.
Approved Labeled Indication: To differentiate between pituitary and ectopic production of ACTH in patients with ACTH-dependent Cushing's syndrome.

Actimmune (Injection) (Subcutaneous) interferon gamma-1b
Drug Classes: Central Nervous System Agents:Multiple Sclerosis Agents == Immunological Agents:Immunostimulants == interferon alpha == interferon beta == interferon gamma
NDA Applicant: Horizon Therapeutics Ireland DAC      BLA No.: 103836  Prod. No.: 001 Rx (100MCG(2MILLION INTERNATIONAL UNITS)/0.5ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityDec 20, 1997Orphan Designation: Treatment of chronic granulomatous disease.
Exclusivity Type: Orphan Drug ExclusivityFeb 10, 2007Orphan Designation: Delaying time to disease progression in patients with severe, malignant osteopetrosis.
Approved Labeled Indication: Delaying time to disease progression in patients with severe, malignant osteopetrosis.

Adagen (Injection) (Intramuscular) pegademase bovine
Drug Classes: bovine intestinal adenosine deaminase
NDA Applicant: Leadiant Biosciences, Inc      BLA No.: 019818  Prod. No.: 001 Disc (375UNITS/1.5ML (250UNITS/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMar 21, 1997Orphan Designation: For enzyme replacement therapy for ADA deficiency in patients with severe combined immunodeficiency.

Adakveo (Injection) (Intravenous) crizanlizumab-tmca
NDA Applicant: Novartis Pharmaceuticals Corporation      BLA No.: 761128  Prod. No.: 001 Rx (100MG/10ML (10MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityNov 15, 2026Orphan Designation: Treatment of sickle cell disease
Approved Labeled Indication: ADAKVEO_ is indicated to reduce the frequency of vasoocclusive crises (VOCs) in adults and pediatric patients aged 16 years and older with sickle cell disease.
Exclusivity Protected Indication: Indicated to reduce the frequency of vasoocclusive crises (VOCs) in adults and pediatric patients aged 16 years and older with sickle cell disease.

Adcetris (For Injection) (Intravenous) brentuximab vedotin
Drug Classes: Antineoplastics:Monoclonal Antibody/Antibody-Drug Conjugate == CD30-directed antibody-drug conjugate
NDA Applicant: Seagen Inc.      BLA No.: 125388  Prod. No.: 001 Rx (50MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityAug 19, 2018Orphan Designation: Treatment of peripheral T-cell lymphoma, including anaplastic large cell lymphoma, peripheral T-cell lymphoma not otherwise specified, angioimmunoblastic T-cell lymphoma, adult T-cell leukemia/lymphoma, enteropathy-associated T-cell lymphoma, and extranod
Approved Labeled Indication: The treatment of patients with systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen
Exclusivity Type: Orphan Drug ExclusivityAug 19, 2018Orphan Designation: Treatment of Hodgkin's lymphoma
Approved Labeled Indication: The treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant (ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates
Exclusivity Type: Orphan Drug ExclusivityAug 17, 2022Orphan Designation: Treatment of Hodgkin's lymphoma
Approved Labeled Indication: Treatment of patients with classical Hodgkin lymphoma at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation.
Exclusivity Protected Indication: Treatment of patients with classical Hodgkin lymphoma at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation.
Exclusivity Type: Orphan Drug ExclusivityNov 9, 2024Orphan Designation: Treatment of mycosis fungoides
Approved Labeled Indication: Treatment for adult patients with CD30-expressing mycosis fungoides who have received prior systemic therapy
Exclusivity Protected Indication: Treatment for adult patients with CD30-expressing mycosis fungoides who have received prior systemic therapy
Exclusivity Type: Orphan Drug ExclusivityNov 9, 2024Orphan Designation: Treatment of primary cutaneous CD30-positive T-cell lymphoproliferative disorders
Approved Labeled Indication: For adult patients with primary cutaneous anaplastic large cell lymphoma who have received prior systemic therapy
Exclusivity Protected Indication: For adult patients with primary cutaneous anaplastic large cell lymphoma who have received prior systemic therapy
Exclusivity Type: Orphan Drug ExclusivityMar 20, 2025Orphan Designation: Treatment of Hodgkin's lymphoma
Approved Labeled Indication: ADCETRIS_ is indicated for the treatment of adult patients with previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with chemotherapy.
Exclusivity Protected Indication: ADCETRIS_ is indicated for the treatment of adult patients with previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with chemotherapy.
Exclusivity Type: Orphan Drug ExclusivityNov 16, 2025Orphan Designation: Treatment of peripheral T-cell lymphoma, including anaplastic large cell lymphoma, peripheral T-cell lymphoma not otherwise specified, angioimmunoblastic T-cell lymphoma, adult T-cell leukemia/lymphoma, enteropathy-associated T-cell lymphoma, and extranod
Approved Labeled Indication: ADCETRIS is indicated for the treatment of adult patients with previously untreated sALCL or other CD30-expressing PTCL, including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone
Exclusivity Protected Indication: ADCETRIS is indicated for the treatment of adult patients with previously untreated sALCL or other CD30-expressing PTCL, including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone

Aldurazyme (Injection) (Intravenous) laronidase
Drug Classes: Genetic, Enzyme, or Protein Disorder: Replacement, Modifiers, Treatment == hydrolytic lysozomal glycosaminoglycan (GAG)-specific enzyme
NDA Applicant: BioMarin Pharmaceutical Inc.      BLA No.: 125058  Prod. No.: 001 Rx (2.9MG/5ML (0.58MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityApr 30, 2010Orphan Designation: Treatment of patients with mucopolysaccharidosis-I.
Approved Labeled Indication: Treatment for patients with Hurler and Hurler-Scheie forms of Mucopolysaccharidosis I (MPS I) and for patients with the Scheie form who have moderate to severe symptoms

Alphanate (For Injection) (Intravenous) Antihemophilic Factor/von Willebrand Factor Complex (Human)
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

Alphanine, Alphanine Hp, Alphanine Sd (Injection) (Intravenous) Coagulation Factor IX (Human)
Drug Classes: Blood Products and Modifiers:Blood Component Deficiency/ Replacement == human blood coagulation factor ==
NDA Applicant: Grifols Biologicals LLC      BLA No.: 103249  Prod. No.: 001 Rx (500IU); 002 Rx (1000IU); 004 Rx (1500IU) BLA No.: 103249  Prod. No.: 003 Disc (250IU)
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.

Alprolix (For Injection) (Intravenous) Coagulation Factor IX (Recombinant), Fc Fusion Protein
Drug Classes: Blood Products and Modifiers:Blood Component Deficiency/ Replacement == human blood coagulation factor ==
NDA Applicant: Bioverativ Therapeutics, Inc.      BLA No.: 125444  Prod. No.: 001 Rx (500IU); 002 Rx (2000IU); 003 Rx (1000IU); 004 Rx (3000IU); 005 Rx (250IU); 006 Rx (4000IU)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMar 28, 2021Orphan Designation: Control and prevention of hemorrhagic episodes in patients with hemophilia B (congenital factor IX deficiency or Christmas disease)
Approved Labeled Indication: Adults and children with Hemophilia B for control and prevention of bleeding episodes, perioperative management, and routine prophylaxis to prevent or reduce the frequency of bleeding episodes.
Exclusivity Protected Indication: Adults and children with Hemophilia B for control and prevention of bleeding episodes, perioperative management, and routine prophylaxis to prevent or reduce the frequency of bleeding episodes.

Anascorp (For Injection) (Intravenous) Centruroides (Scorpion) Immune F(ab')2 (Equine) Injection
Drug Classes: antivenin
NDA Applicant: Rare Disease Therapeutics, Inc. (RDT)      BLA No.: 125335  Prod. No.: 001 Rx (>/=150 LD50 NEUTRALIZING UNITS)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityAug 4, 2018Orphan Designation: Treatment of scorpion envenomations requiring medical attention.
Approved Labeled Indication: Treatment of clinical signs of scorpion envenomation

Anavip (For Injection) (Intravenous) Crotalidae Immune F(ab')2 (Equine)
NDA Applicant: Rare Disease Therapeutics, Inc. (RDT)      BLA No.: 125488  Prod. No.: 001 Rx (MINIMUM 780 BOTHROPS ASPER, 790 C.SIMUS, 244 C.ADAMANTEUS, 147 C.ATROX, 185 C.SCUTULATUS, 28 AGKISTRODON CONTORTRIX, 61 A.PISCIVORUS LD50 NEUTRALIZING UNITS/VIAL)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMay 6, 2022Orphan Designation: Treatment of envenomation by Crotaline snakes
Approved Labeled Indication: Management of adult and pediatric patients with North American rattlesnake envenomation
Exclusivity Protected Indication: Management of adult and pediatric patients with North American rattlesnake envenomation

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

Anthim (Injection) (Intravenous) obiltoxaximab
Drug Classes: monoclonal antibody directed against the protective antigen of Bacillus anthracis
NDA Applicant: Elusys Therapeutics, Inc.      BLA No.: 125509  Prod. No.: 001 Rx (600MG/6ML (100MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMar 18, 2023Orphan Designation: Treatment of exposure to B. anthracis spores
Approved Labeled Indication: Treatment of adult and pediatric patients with inhalational anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs and for prophylaxis of inhalational anthrax due to B. anthracis when alternative therapies are not available or are not appropriate.
Exclusivity Protected Indication: 1) Treatment of adult and pediatric patients with inhalational anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs, and (2) for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate.

Anthrasil (Injection) (Intravenous) Anthrax Immune Globulin Intravenous (Human)
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

Arcalyst (For Injection) (Subcutaneous) rilonacept
Drug Classes: Immunological Agents:Immunological Agents, Other
NDA Applicant: Kiniksa Pharmaceuticals (UK), Ltd.      BLA No.: 125249  Prod. No.: 001 Rx (220MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityFeb 27, 2015Orphan Designation: Treatment of CIAS1-Associated Periodic Syndromes
Approved Labeled Indication: Treatment of Cryopyrin-Assisted Periodic Syndromes (CAPS)
Exclusivity Type: Orphan Drug ExclusivityMar 18, 2028Orphan Designation: Treatment of pericarditis
Approved Labeled Indication: Treatment of recurrent pericarditis (RP) and reduction in risk of recurrence in adults and pediatric patients 12 years and older
Exclusivity Protected Indication: Treatment of recurrent pericarditis (RP) and reduction in risk of recurrence in adults and pediatric patients 12 years and older

Arzerra (Injection) (Intravenous) ofatumumab
Drug Classes: Antineoplastics:Monoclonal Antibody/Antibody-Drug Conjugate == CD20-directed cytolytic antibody
NDA Applicant: Novartis Pharmaceuticals Corporation      BLA No.: 125326  Prod. No.: 001 Rx (100MG/5ML); 002 Rx (1,000MG/50ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityOct 26, 2016Orphan Designation: Treatment of chronic lymphocytic leukemia
Approved Labeled Indication: Treatment of chronic lymphocytic leukemia (CLL) refractory to alemtuzumab and fludarabine
Exclusivity Type: Orphan Drug ExclusivityApr 17, 2021Orphan Designation: Treatment of chronic lymphocytic leukemia
Approved Labeled Indication: ARZERRA (ofatumumab) is indicated, in combination with chlorambucil, for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL) for whom fludarabine-based therapy is considered inappropriate.
Exclusivity Protected Indication: Ofatumumab in combination with chlorambucil, for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL) for whom fludarabine-based therapy is considered inappropriate.
Exclusivity Type: Orphan Drug ExclusivityJan 19, 2023Orphan Designation: Treatment of chronic lymphocytic leukemia
Approved Labeled Indication: For extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive CLL.
Exclusivity Protected Indication: For extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive CLL.

Asparlas (Injection) (Intravenous) calaspargase pegol-mknl
Drug Classes: Antineoplastics:Antineoplastics, Other == asparagine specific enzyme
NDA Applicant: Servier Pharmaceuticals LLC      BLA No.: 761102  Prod. No.: 001 Rx (3,750UNITS/5ML (750UNITS/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityFeb 1, 2001Orphan 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.

Atryn (For Injection) (Intravenous) Antithrombin (Recombinant)
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.

Autoplex, Feiba Nf, Feiba Vh (For Injection) (Intravenous) Anti-Inhibitor Coagulant Complex
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.

Avastin (Injection) (Intravenous) bevacizumab
Drug Classes: Antineoplastics:Monoclonal Antibody/Antibody-Drug Conjugate == Ophthalmic Agents:Ophthalmic Agents, Other
NDA Applicant: Genentech, Inc.      BLA No.: 125085  Prod. No.: 001 Rx (100MG/4ML (25MG/ML)); 002 Rx (400MG/16ML (25MG/ML))
PatentsExpirationPatented Use
Pat. No. 7485704 Reducing protein A leaching during protein A affinity chromatography
Claim Types: Process
Pat. Sub. Date(s): None
Mar 7, 2025 
Pat. No. 8460895 Method for producing recombinant proteins with a constant content of pCO.sub.2 in the medium
Claim Types: Process
Pat. Sub. Date(s): None
Mar 10, 2029 
Pat. No. 8512983 Production of proteins in glutamine-free cell culture media
Claim Types: Process; Cell culture medium
Pat. Sub. Date(s): None
Jan 3, 2031 
Pat. No. 8574869 Prevention of disulfide bond reduction during recombinant production of polypeptides
Claim Types: Process
Pat. Sub. Date(s): None
Jul 7, 2028 
Pat. No. 9441035 Cell culture media and methods of antibody production
Claim Types: Process
Pat. Sub. Date(s): None
Apr 22, 2034 
Pat. No. 9487809 Decreasing lactate level and increasing polypeptide production by downregulating the expression of lactate dehydrogenase and pyruvate dehydrogenase kinase
Claim Types: Process
Pat. Sub. Date(s): None
Jan 13, 2032 
Pat. No. 9714293 Production of proteins in glutamine-free cell culture media
Claim Types: Process
Pat. Sub. Date(s): None
Aug 5, 2030 
Pat. No. 9795672 Treatment with anti-VEGF antibodies
Claim Types: Method of use
Pat. Sub. Date(s): None
May 27, 2024 
Pat. No. 10011856 Decreasing lactate level and increasing polypeptide production by downregulating the expression of lactate dehydrogenase and pyruvate dehydrogenase kinase
Claim Types: Cell culture
Pat. Sub. Date(s): None
May 25, 2031 
Pat. No. 10017732 Cell culture compositions with antioxidants and methods for polypeptide production
Claim Types: Process
Pat. Sub. Date(s): None
Mar 13, 2034 
Pat. No. 10208355 Method of treatment for glioblastoma by administering a VEGF antagonist
Claim Types: Method of use
Pat. Sub. Date(s): None
Jul 13, 2035 
Pat. No. 10274466 Elucidation of ion exchange chromatography input optimization
Claim Types: Analytical procedure
Pat. Sub. Date(s): None
Jul 10, 2035 
Pat. No. 10336983 Method for increasing the specific production rate of eukaryotic cells
Claim Types: Process
Pat. Sub. Date(s): None
Jul 30, 2035 
Pat. No. 10513697 CO.sub.2 profile cultivation
Claim Types: Process
Pat. Sub. Date(s): None
Sep 16, 2032 
Pat. No. 10662237 Method to improve virus filtration capacity
Claim Types: Process
Pat. Sub. Date(s): None
May 25, 2031 
Pat. No. 10676710 Cell culture compositions with antioxidants and methods for polypeptide production
Claim Types: Process
Pat. Sub. Date(s): None
Mar 13, 2034 
Pat. No. 10704071 Decreasing lactate level and increasing polypeptide production by down regulating the expression of lactate dehydrogenase and pyruvate dehydrogenase kinase
Claim Types: Vector
Pat. Sub. Date(s): None
Aug 17, 2031 
Pat. No. 10829732 Cell culture compositions with antioxidants and methods for polypeptide production
Claim Types: Process
Pat. Sub. Date(s): None
Mar 13, 2034 
Pat. No. 10906934 Protein purification methods
Claim Types: Process
Pat. Sub. Date(s): None
Oct 11, 2033 
Pat. No. 10906986 Prevention of disulfide bond reduction during recombinant production of polypeptides
Claim Types: Process
Pat. Sub. Date(s): None
Jul 7, 2028 
Pat. No. 10982003 Production of proteins in glutamine-free cell culture media
Claim Types: Process
Pat. Sub. Date(s): None
Aug 6, 2030 
Pat. No. 11078294 Prevention of disulfide bond reduction during recombinant production of polypeptides
Claim Types: Process
Pat. Sub. Date(s): None
Jul 8, 2028 
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMay 5, 2016Orphan Designation: Treatment of malignant glioma
Approved Labeled Indication: Treatment of glioblastoma with progressive disease following prior therapy
Exclusivity Type: Orphan Drug ExclusivityJul 31, 2016Orphan Designation: Treatment of renal cell carcinoma
Approved Labeled Indication: Treatment of renal cell carcinoma in combination with interferon alfa
Exclusivity Type: Orphan Drug ExclusivityNov 14, 2021Orphan Designation: Treatment of primary peritoneal carcinoma.
Approved Labeled Indication: In combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for treatment of patients with platinum-resistant, recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than 2 prior chemotherapy regimens
Exclusivity Protected Indication: In combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for treatment of patients with platinum-resistant, recurrent primary peritoneal cancer who received no more than 2 prior chemotherapy regimens
Exclusivity Type: Orphan Drug ExclusivityNov 14, 2021Orphan Designation: Treatment of fallopian tube carcinoma
Approved Labeled Indication: In combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for treatment of patients with platinum-resistant, recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received no more than 2 prior chemotherapy regimens.
Exclusivity Protected Indication: In combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for treatment of patients with platinum-resistant, recurrent fallopian tube cancer who have received no more than 2 prior chemotherapy regimens.
Exclusivity Type: Orphan Drug ExclusivityNov 14, 2021Orphan Designation: Therapeutic treatment of patients with ovarian cancer
Approved Labeled Indication: In combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for treatment of patients with platinum-resistant, recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than 2 prior chemotherapy regimens
Exclusivity Protected Indication: In combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for treatment of patients with platinum-resistant, recurrent epithelial ovarian cancer who have received no more than 2 prior chemotherapy regimens.
Exclusivity Type: Orphan Drug ExclusivityDec 6, 2023Orphan Designation: Treatment of primary peritoneal carcinoma.
Approved Labeled Indication: Avastin in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan is indicated for the treatment of patients with platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who received no more than 2 prior chemotherapy regimens. Avastin, either in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine, followed by Avastin as a single agent, is indicated for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Exclusivity Protected Indication: Either in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine, followed by Avastin as a single agent, is indicated for the treatment of patients with platinum-sensitive recurrent primary peritoneal cancer.
Exclusivity Type: Orphan Drug ExclusivityDec 6, 2023Orphan Designation: Treatment of fallopian tube carcinoma
Approved Labeled Indication: Avastin in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan is indicated for the treatment of patients with platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who received no more than 2 prior chemotherapy regimens. Avastin, either in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine, followed by Avastin as a single agent, is indicated for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Exclusivity Protected Indication: Either in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine, followed by Avastin as a single agent, is indicated for the treatment of patients with platinum-sensitive recurrent fallopian tube cancer.
Exclusivity Type: Orphan Drug ExclusivityDec 6, 2023Orphan Designation: Therapeutic treatment of patients with ovarian cancer
Approved Labeled Indication: Avastin in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan is indicated for the treatment of patients with platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who received no more than 2 prior chemotherapy regimens. Avastin, either in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine, followed by Avastin as a single agent, is indicated for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Exclusivity Protected Indication: Either in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine, followed by Avastin as a single agent, is indicated for the treatment of patients with platinum-sensitive recurrent epithelial ovarian cancer.
Exclusivity Type: Orphan Drug ExclusivityJun 13, 2025Orphan Designation: Treatment of fallopian tube carcinoma
Approved Labeled Indication: Avastin, in combination with carboplatin and paclitaxel, followed by Avastin as a single agent, is indicated for the treatment of patients with stage III or IV epithelial ovarian, fallopian tube, orprimary peritoneal cancer following initial surgical resection. Avastin, in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan, is indicated for the treatment of patients with platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who received no more than 2 prior chemotherapy regimens. Avastin, in combination with carboplatin and paclitaxel, or with carboplatin and gemcitabine, followed by Avastin as a single agent, is indicated for the treatment of patients with platinum-sensitiverecurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Exclusivity Protected Indication: In combination with carboplatin and paclitaxel, followed by Avastin as a single agent, is indicated for the treatment of patients with stage III or IV fallopian tube cancer following initial surgical resection.
Exclusivity Type: Orphan Drug ExclusivityJun 13, 2025Orphan Designation: Treatment of primary peritoneal carcinoma.
Approved Labeled Indication: Avastin, in combination with carboplatin and paclitaxel, followed by Avastin as a single agent, is indicated for the treatment of patients with stage III or IV epithelial ovarian, fallopian tube, orprimary peritoneal cancer following initial surgical resection. Avastin, in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan, is indicated for the treatment of patients with platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who received no more than 2 prior chemotherapy regimens. Avastin, in combination with carboplatin and paclitaxel, or with carboplatin and gemcitabine, followed by Avastin as a single agent, is indicated for the treatment of patients with platinum-sensitiverecurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Exclusivity Protected Indication: In combination with carboplatin and paclitaxel, followed by Avastin as a single agent, is indicated for the treatment of patients with stage III or IV primary peritoneal cancer following initial surgical resection.
Exclusivity Type: Orphan Drug ExclusivityJun 13, 2025Orphan Designation: Therapeutic treatment of patients with ovarian cancer
Approved Labeled Indication: Avastin, in combination with carboplatin and paclitaxel, followed by Avastin as a single agent, is indicated for the treatment of patients with stage III or IV epithelial ovarian, fallopian tube, orprimary peritoneal cancer following initial surgical resection. Avastin, in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan, is indicated for the treatment of patients with platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who received no more than 2 prior chemotherapy regimens. Avastin, in combination with carboplatin and paclitaxel, or with carboplatin and gemcitabine, followed by Avastin as a single agent, is indicated for the treatment of patients with platinum-sensitiverecurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Exclusivity Protected Indication: In combination with carboplatin and paclitaxel, followed by Avastin as a single agent, is indicated for the treatment of patients with stage III or IV epithelial ovarian cancer following initial surgical resection.
Exclusivity Type: Orphan Drug ExclusivityMay 29, 2027Orphan 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.

Avonex (For Injection) (Intramuscular) interferon beta-1a
Drug Classes: Central Nervous System Agents:Multiple Sclerosis Agents == Immunological Agents:Immunostimulants == interferon alpha == interferon beta == interferon gamma
NDA Applicant: Biogen Inc.      BLA No.: 103628  Prod. No.: 002 Rx (30MCG/0.5ML); 003 Rx (30MCG/0.5ML) BLA No.: 103628  Prod. No.: 001 Disc (30MCG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMay 17, 2003Orphan Designation: Treatment of multiple sclerosis.
Approved Labeled Indication: Treatment of relapsing forms of multiple sclerosis to slow the accumulation of physical disability and decrease the frequency of clinical exacerbations.



Last edited: 15 November 2022
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