Company names starting with "B"

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.


Baxalta US Inc.
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.

Baxalta US Inc.
Ceprotin (For Injection) (Intravenous) Protein C Concentrate (Human)
Drug Classes: Blood Products and Modifiers:Blood Component Deficiency/ Replacement == anticoagulant
NDA Applicant: Baxalta US Inc.      BLA No.: 125234  Prod. No.: 001 Rx (500IU); 002 Rx (1000IU)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMar 30, 2014Orphan Designation: For replacement therapy in congenital protein C deficiency for the prevention and treatment of thrombosis, pulmonary emboli, and purpura fulminans.
Approved Labeled Indication: Prevention and treatment of venous thrombosis and purpura fulminans

Baxalta US Inc.
Gammagard Liquid (Injection) (Intravenous, Subcutaneous) Immune Globulin Infusion (Human)
Drug Classes: Immunological Agents:Immunoglobulins == human immunoglobulin G
NDA Applicant: Baxalta US Inc.      BLA No.: 125105  Prod. No.: 001 Rx (10% MG/ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJun 22, 2019Orphan Designation: Treatment of multifocal motor neuropathy
Approved Labeled Indication: Maintenance therapy to improve muscle strength and disability in adult patients with Multifocal Motor Neuropathy (MMN).

Baxalta US Inc.
Obizur (For Injection) (Intravenous) Antihemophilic Factor (Recombinant), Porcine Sequence
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.

Baxalta US Inc.
Rixubis (For Injection) (Intravenous) Coagulation Factor IX (Recombinant)
Drug Classes: Blood Products and Modifiers:Blood Component Deficiency/ Replacement == human blood coagulation factor ==
NDA Applicant: Baxalta US Inc.      BLA No.: 125446  Prod. No.: 001 Rx (500IU); 002 Rx (1000IU); 003 Rx (250IU); 004 Rx (3000IU); 005 Rx (2000IU)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJun 26, 2020Orphan Designation: Prophylactic use to prevent or reduce the frequency of bleeding episodes in patients with hemophilia B (routine prophylaxis in patients where there is no evidence or suspicion of bleeding)
Approved Labeled Indication: Adults with Hemophilia B for (1) control and prevention of bleeding episodes, (2) perioperative management, and (3) routine prophylaxis to prevent or reduce the frequency of bleeding episodes.
Exclusivity Protected Indication: Adults with Hemophilia B for routine prophylaxis to prevent or reduce the frequency of bleeding episodes.
Exclusivity Type: Orphan Drug ExclusivitySep 12, 2021Orphan Designation: Prophylactic use to prevent or reduce the frequency of bleeding episodes in patients with hemophilia B (routine prophylaxis in patients where there is no evidence or suspicion of bleeding)
Approved Labeled Indication: Adults and children with Hemophilia B for (1) control and prevention of bleeding episodes, (2) perioperative management, and (3) routine prophylaxis
Exclusivity Protected Indication: Children with hemophilia B for routine prophylaxis.

Baxalta US Inc.
Vonvendi (For Injection) (Intravenous) von Willebrand factor (Recombinant)
Drug Classes: Blood Products and Modifiers:Blood Component Deficiency/ Replacement == human blood coagulation factor
NDA Applicant: Baxalta US Inc.      BLA No.: 125577  Prod. No.: 001 Rx (1300IU); 002 Rx (650IU)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityDec 8, 2022Orphan Designation: Treatment of von Willebrand disease
Approved Labeled Indication: Indicated for on-demand treatment and control of bleeding episodes in adults (age 18 and older) diagnosed with von Willebrand disease (VWD)
Exclusivity Protected Indication: Indicated for on-demand treatment and control of bleeding episodes in adults diagnosed with von Willebrand disease (VWD)
Exclusivity Type: Orphan Drug ExclusivityApr 13, 2025Orphan Designation: Treatment of von Willebrand disease
Approved Labeled Indication: Indicated for use in adults (age 18 and older) diagnosed with von Willebrand disease (VWD) for perioperative management of bleeding
Exclusivity Protected Indication: Indicated for use in adults (age 18 and older) diagnosed with von Willebrand disease (VWD) for perioperative management of bleeding

Bayer HealthCare LLC
Helixate Fs, Kogenate, Kogenate Fs (For Injection) (Intravenous) Antihemophilic Factor (Recombinant)
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.

Bayer HealthCare Pharmaceuticals Inc.
Betaseron (For Injection) (Subcutaneous) interferon beta-1b
Drug Classes: Central Nervous System Agents:Multiple Sclerosis Agents == Immunological Agents:Immunostimulants == interferon alpha == interferon beta == interferon gamma
NDA Applicant: Bayer HealthCare Pharmaceuticals Inc.      BLA No.: 103471  Prod. No.: 001 Rx (0.3MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJul 23, 2000Orphan Designation: Treatment of multiple sclerosis.
Approved Labeled Indication: In ambulatory patients with relapsing-remitting multiple sclerosis to reduce the frequency of clinical exacerbations.

Bayer HealthCare Pharmaceuticals Inc.
Trasylol (Injection) (Intravenous) aprotinin
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

Bio Products Laboratory
Coagadex (For Injection) (Intravenous) Coagulation Factor X (Human)
Drug Classes: Blood Products and Modifiers:Blood Component Deficiency/ Replacement == human blood coagulation factor ==
NDA Applicant: Bio Products Laboratory      BLA No.: 125506  Prod. No.: 001 Rx (500IU); 002 Rx (250IU)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityOct 20, 2022Orphan Designation: Treatment of hereditary factor X deficiency
Approved Labeled Indication: Treatment of adults and adolescents (aged 12 years and above) with hereditary Factor X deficiency for on-demand treatment and control of bleeding episodes and perioperative management of bleeding in patients with mild hereditary Factor X deficiency
Exclusivity Protected Indication: Treatment of adults and adolescents (aged 12 years and above) with hereditary Factor X deficiency for on-demand treatment and control of bleeding episodes and perioperative management of bleeding in patients with mild hereditary Factor X deficiency
Exclusivity Type: Orphan Drug ExclusivitySep 21, 2025Orphan Designation: Treatment of hereditary factor X deficiency
Approved Labeled Indication: COAGADEX is indicated in adults and children with hereditary Factor X deficiency for routine prophylaxis to reduce the frequency of bleeding episodes; on-demand treatment and control of bleeding episodes; and perioperative management of bleeding in patients with mild and moderate hereditary Factor X deficiency.
Exclusivity Protected Indication: Coagadex is indicated for routine prophylaxis to reduce the frequency of bleeding episodes in adults and children with hereditary Factor X deficiency; on-demand treatment and control of bleeding episodes in children under the age of 12 years with hereditary Factor X deficiency; perioperative management of bleeding in children under the age of 12 years with mild hereditary factor X deficiency; perioperative management of bleeding in adults and children with moderate hereditary Factor X deficiency

Biogen Inc.
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.

Biogen Inc.
Tysabri (Injection) (Intravenous) natalizumab
Drug Classes: Central Nervous System Agents:Multiple Sclerosis Agents == Immunological Agents:Immunological Agents, Other == integrin receptor antagonist
NDA Applicant: Biogen Inc.      BLA No.: 125104  Prod. No.: 001 Rx (300MG/15ML (20MG/ML))
PatentsExpirationPatented Use
Pat. No. 7157276 Use of depth filtration in series with continuous centrifugation to clarify mammalian cell cultures
Claim Types: Process
Pat. Sub. Date(s): None
Jun 21, 2024 
Pat. No. 7759117 Use of depth filtration in series with continuous centrifugation to clarify mammalian cell cultures
Claim Types: Process
Pat. Sub. Date(s): None
Jun 21, 2024 
Pat. No. 8124350 Methods and products for evaluating an immune response to a therapeutic protein
Claim Types: Diagnostic or surgical method
Pat. Sub. Date(s): None
Aug 2, 2027 
Pat. No. 8318416 Nutrient monitoring and feedback control for increased bioproduct production
Claim Types: Process
Pat. Sub. Date(s): None
Jan 20, 2031 
Pat. No. 8809049 Methods for producing mammalian cells
Claim Types: Process
Pat. Sub. Date(s): None
May 22, 2031 
Pat. No. 8871449 Methods and products for evaluating an immune response to a therapeutic protein
Claim Types: Diagnostic or surgical method
Pat. Sub. Date(s): None
Apr 12, 2026 
Pat. No. 9005926 Methods of preventing and removing trisulfide bonds
Claim Types: Process
Pat. Sub. Date(s): None
Oct 1, 2030 
Pat. No. 9096879 Method of supplementing culture media to prevent undesirable amino acid substitutions
Claim Types: Process
Pat. Sub. Date(s): None
Jan 7, 2031 
Pat. No. 9109015 Method of isolating biomacromolecules using low pH and divalent cations
Claim Types: Process
Pat. Sub. Date(s): None
Aug 13, 2031 
Pat. No. 9212379 Nutrient monitoring and feedback control for increased bioproduct production
Claim Types: Process
Pat. Sub. Date(s): None
Nov 28, 2030 
Pat. No. 9316641 Assay for JC virus antibodies
Claim Types: Diagnostic or surgical method
Pat. Sub. Date(s): None
Jan 9, 2032 
Pat. No. 9493567 Methods of treating inflammatory and autoimmune diseases with natalizumab
Claim Types: Method of use
Pat. Sub. Date(s): None
Mar 5, 2027 
Pat. No. 9562252 Methods of preventing and removing trisulfide bonds
Claim Types: Process
Pat. Sub. Date(s): None
May 11, 2033 
Pat. No. 9696307 Methods for the detection of JC polyoma virus
Claim Types: Diagnostic or surgical method
Pat. Sub. Date(s): None
Feb 5, 2030 
Pat. No. 9709575 Methods and products for evaluating an immune response to a therapeutic protein
Claim Types: Diagnostic or surgical method
Pat. Sub. Date(s): None
Apr 4, 2026 
Pat. No. 9790533 Methods of preventing and removing trisulfide bonds
Claim Types: Cell culture
Pat. Sub. Date(s): None
May 11, 2032 
Pat. No. 9994968 Electrochemical etching apparatus
Claim Types: Process
Pat. Sub. Date(s): None
Aug 19, 2034 
Pat. No. 10023831 Gas delivery devices and associated systems and methods
Claim Types: Device
Pat. Sub. Date(s): None
Mar 17, 2035 
Pat. No. 10119976 Method of assessing risk of PML
Claim Types: Diagnostic or surgical method; Method of use
Pat. Sub. Date(s): None
May 27, 2034 
Pat. No. 10233245 Methods of treating inflammatory and autoimmune diseases with natalizumab
Claim Types: Method of use
Pat. Sub. Date(s): None
Feb 28, 2027 
Pat. No. 10308706 Methods of preventing and removing trisulfide bonds
Claim Types: Process
Pat. Sub. Date(s): None
Feb 5, 2032 
Pat. No. 10444234 Assay for JC virus antibodies
Claim Types: Diagnostic or surgical method; Device
Pat. Sub. Date(s): None
Jan 11, 2031 
Pat. No. 10590454 Methods of preventing and removing trisulfide bonds
Claim Types: Process
Pat. Sub. Date(s): None
May 11, 2032 
Pat. No. 10676772 Control of protein glycosylation by culture medium supplementation and cell culture process parameters
Claim Types: Process
Pat. Sub. Date(s): None
Aug 19, 2034 
Pat. No. 10677803 Method of assessing risk of PML
Claim Types: Method of use
Pat. Sub. Date(s): None
May 27, 2034 
Pat. No. 10705095 Methods and products for evaluating an immune response to a therapeutic protein
Claim Types: Diagnostic or surgical method
Pat. Sub. Date(s): None
Apr 4, 2026 
Pat. No. 10844416 Manganese supplementation for control of glycosylation in mammalian cell culture process
Claim Types: Process
Pat. Sub. Date(s): None
Jan 6, 2036 
Pat. No. 11124760 Methods for overcoming glutamine deprivation during mammalian cell culture
Claim Types: Process
Pat. Sub. Date(s): None
Aug 27, 2035 
Pat. No. 11268119 Copper supplementation for control of glycosylation in mammalian cell culture process
Claim Types: Process
Pat. Sub. Date(s): None
Feb 21, 2036 
Pat. No. 11280794 Method of assessing risk of PML
Claim Types: Method of use
Pat. Sub. Date(s): None
May 27, 2034 
Pat. No. 11287423 Assay for JC virus antibodies
Claim Types: Formulation; Process
Pat. Sub. Date(s): None
Jan 11, 2031 
Pat. No. 11292845 Methods of treating inflammatory and autoimmune diseases with natalizumab
Claim Types: Method of use
Pat. Sub. Date(s): None
Feb 28, 2027 

BioMarin Pharmaceutical Inc.
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

BioMarin Pharmaceutical Inc.
Brineura (Injection) (Intraventricular) cerliponase alfa
Drug Classes: Genetic, Enzyme, or Protein Disorder: Replacement, Modifiers, Treatment == hydrolytic lysosomal N-terminal tripeptidyl peptidase
NDA Applicant: BioMarin Pharmaceutical Inc.      BLA No.: 761052  Prod. No.: 001 Rx (150MG/5ML (30MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityApr 27, 2024Orphan Designation: Treatment of neuronal ceroid lipofuscinosis type 2
Approved Labeled Indication: To slow the loss of ambulation in symptomatic pediatric patients 3 years of age and older with late infantile neuronal ceroid lipofuscinosis type 2 (CLN2), also known as tripeptidyl peptidase 1 (TPP1) deficiency.
Exclusivity Protected Indication: To slow the loss of ambulation in symptomatic pediatric patients 3 years of age and older with late infantile neuronal ceroid lipofuscinosis type 2 (CLN2), also known as tripeptidyl peptidase 1 (TPP1) deficiency.

BioMarin Pharmaceutical Inc.
Naglazyme (Injection) (Intravenous) galsulfase
Drug Classes: Genetic, Enzyme, or Protein Disorder: Replacement, Modifiers, Treatment == hydrolytic lysozomal glycosaminoglycan (GAG)-specific enzyme
NDA Applicant: BioMarin Pharmaceutical Inc.      BLA No.: 125117  Prod. No.: 001 Rx (5MG/5ML (1MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMay 31, 2012Orphan 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.

BioMarin Pharmaceutical Inc.
Palynziq (Injection) (Subcutaneous) pegvaliase-pqpz
NDA Applicant: BioMarin Pharmaceutical Inc.      BLA No.: 761079  Prod. No.: 001 Rx (2.5MG/0.5ML); 002 Rx (10MG/0.5ML); 003 Rx (20MG/ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMay 24, 2025Orphan Designation: Treatment of hyperphenylalaninemia
Approved Labeled Indication: Palynziq is indicated to reduce blood phenylalanine concentrations in adult patients with phenylketonuria (PKU) who have uncontrolled blood phenylalanine concentrations greater than 600 micromol/L on existing management
Exclusivity Protected Indication: Palynziq is indicated to reduce blood phenylalanine concentrations in adult patients with phenylketonuria (PKU) who have uncontrolled blood phenylalanine concentrations greater than 600 micromol/L on existing management

BioMarin Pharmaceutical Inc.
Vimizim (Injection) (Intravenous) elosulfase alfa
Drug Classes: Genetic, Enzyme, or Protein Disorder: Replacement, Modifiers, Treatment == hydrolytic lysozomal glycosaminoglycan (GAG)-specific enzyme
NDA Applicant: BioMarin Pharmaceutical Inc.      BLA No.: 125460  Prod. No.: 001 Rx (5MG/5ML (1MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityFeb 14, 2021Orphan Designation: Use in the treatment of mucopolysaccharidosis (MPS) Type IV A (Morquio A syndrome)
Approved Labeled Indication: Patients with Mucopolysaccharidosis type IVA (MPS IVA; Morquio A syndrome)
Exclusivity Protected Indication: Patients with Mucopolysaccharidosis type IVA (MPS IVA; Morquio A syndrome)

Bioverativ Therapeutics, Inc.
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.

Bioverativ Therapeutics, Inc.
Eloctate (For Injection) (Intravenous) Antihemophilic Factor (Recombinant), Fc Fusion protein
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.

Bluebird Bio Inc.
Skysona (Injection) (Intravenous) elivaldogene autotemcel
NDA Applicant: Bluebird Bio Inc.      BLA No.: 125755  Prod. No.: 001 Rx (2-30 × 10^6 CELL/ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Ref. Product ExclusivitySep 16, 2034 

Bluebird Bio Inc.
Zynteglo (For Injection) (Intravenous) betibeglogene autotemcel
NDA Applicant: Bluebird Bio Inc.      BLA No.: 125717  Prod. No.: 001 Rx (1.7-20 X 10^6CELL/ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Ref. Product ExclusivityAug 17, 2034 

Boehringer Ingelheim Pharmaceuticals, Inc.
Cyltezo (Injection) (Subcutaneous) adalimumab-adbm
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 

Boehringer Ingelheim Pharmaceuticals, Inc.
Praxbind (Injection) (Intravenous) idarucizumab
Drug Classes: humanized monoclonal antibody fragment (Fab)
NDA Applicant: Boehringer Ingelheim Pharmaceuticals, Inc.      BLA No.: 761025  Prod. No.: 001 Rx (2.5G/50ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityOct 16, 2022Orphan Designation: To reverse the anticoagulant effect of dabigatran due to uncontrolled life-threatening bleeding requiring urgent intervention or a need to undergo an emergency surgery/urgent invasive procedure
Approved Labeled Indication: For use in patients treated with Pradaxa_ when reversal of the anticoagulant effects of dabigatran is needed for emergency surgery/urgent procedures and in life-threatening or uncontrolled bleeding
Exclusivity Protected Indication: For use in patients treated with Pradaxa_ when reversal of the anticoagulant effects of dabigatran is needed for emergency surgery/urgent procedures and in life-threatening or uncontrolled bleeding

Bristol-Myers Squibb Company
Empliciti (For Injection) (Intravenous) elotuzumab
Drug Classes: Antineoplastics:Monoclonal Antibody/Antibody-Drug Conjugate == SLAMF7-directed immunostimulatory antibody
NDA Applicant: Bristol-Myers Squibb Company      BLA No.: 761035  Prod. No.: 001 Rx (300MG); 002 Rx (400MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityNov 30, 2022Orphan Designation: Treatment of multiple myeloma
Approved Labeled Indication: Indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received one to three prior therapies
Exclusivity Protected Indication: Indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received one to three prior therapies
Exclusivity Type: Orphan Drug ExclusivityNov 6, 2025Orphan Designation: Treatment of multiple myeloma
Approved Labeled Indication: EMPLICITI is indicated in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.
Exclusivity Protected Indication: Indicated in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor, excluding adult patients covered by Empliciti_s previously approved indication for multiple myeloma.

Bristol-Myers Squibb Company
Nulojix (For Injection) (Intravenous) belatacept
Drug Classes: Immunological Agents:Immunological Agents, Other == selective T-cell costimulation blocker
NDA Applicant: Bristol-Myers Squibb Company      BLA No.: 125288  Prod. No.: 001 Rx (250MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJun 15, 2018Orphan Designation: Prophylaxis of organ rejection in renal allograft recipients
Approved Labeled Indication: Prophylaxis of organ rejection in adult patients receiving kidney transplants

Bristol-Myers Squibb Company
Opdivo (Injection) (Intravenous) nivolumab
Drug Classes: Antineoplastics:Monoclonal Antibody/Antibody-Drug Conjugate == human programmed death receptor-1 (PD-1)-blocking antibody
NDA Applicant: Bristol-Myers Squibb Company      BLA No.: 125554  Prod. No.: 001 Rx (40MG/4ML (10MG/ML)); 002 Rx (100MG/10ML (10MG/ML)); 003 Rx (240MG/24ML (10MG/ML)); 004 Rx (120MG/12ML (10MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityDec 22, 2021Orphan Designation: Treatment of Stage IIb to IV melanoma
Approved Labeled Indication: Treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor
Exclusivity Protected Indication: Treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor
Exclusivity Type: Orphan Drug ExclusivityMay 17, 2023Orphan Designation: Treatment of Hodgkin lymphoma
Approved Labeled Indication: Treatment of adult patients with Classical Hodgkin lymphoma that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin
Exclusivity Protected Indication: Treatment of adult patients with Classical Hodgkin lymphoma that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin
Exclusivity Type: Orphan Drug ExclusivityApr 25, 2024Orphan Designation: Treatment of Hodgkin lymphoma
Approved Labeled Indication: Treatment of adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin; or 3 or more lines of systemic therapy that includes autologous HSCT.
Exclusivity Protected Indication: Treatment of adult patients with Classical Hodgkin lymphoma that has relapsed or progressed after 3 or more lines of systemic therapy that includes autologous HSCT, not including any overlap with the orphan exclusivity awarded for the 2016 marketing approval of nivolumab for the treatment of adult patients with classical Hodgkin lymphoma that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin.
Exclusivity Type: Orphan Drug ExclusivityDec 20, 2024Orphan Designation: Treatment of Stage IIb to IV melanoma
Approved Labeled Indication: Adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection
Exclusivity Protected Indication: Adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection
Exclusivity Type: Orphan Drug ExclusivityJun 10, 2027Orphan Designation: Treatment of esophageal cancer
Approved Labeled Indication: Opdivo (nivolumab) indicated for the treatment of patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy.
Exclusivity Protected Indication: For the treatment of patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy.
Exclusivity Type: Orphan Drug ExclusivityApr 16, 2028Orphan Designation: Treatment of esophageal cancer
Approved Labeled Indication: in combination with fluoropyrimidine- and platinum-containing chemotherapy for the treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma
Exclusivity Protected Indication: treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma
Exclusivity Type: Orphan Drug ExclusivityApr 16, 2028Orphan Designation: Treatment of gastric cancer and gastro-esophageal junction cancer
Approved Labeled Indication: in combination with fluoropyrimidine- and platinum-containing chemotherapy for the treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma
Exclusivity Protected Indication: treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma
Exclusivity Type: Orphan Drug ExclusivityMay 20, 2028Orphan Designation: Treatment of esophageal cancer
Approved Labeled Indication: adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in patients who have received neoadjuvant chemoradiotherapy (CRT)
Exclusivity Protected Indication: adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in patients who have received neoadjuvant chemoradiotherapy (CRT)
Exclusivity Type: Orphan Drug ExclusivityMay 20, 2028Orphan Designation: Treatment of gastric cancer and gastro-esophageal junction cancer
Approved Labeled Indication: adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in patients who have received neoadjuvant chemoradiotherapy (CRT)
Exclusivity Protected Indication: adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in patients who have received neoadjuvant chemoradiotherapy (CRT)

Bristol-Myers Squibb Company
Yervoy (Injection) (Intravenous) ipilimumab
Drug Classes: Antineoplastics:Monoclonal Antibody/Antibody-Drug Conjugate == human cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody
NDA Applicant: Bristol-Myers Squibb Company      BLA No.: 125377  Prod. No.: 001 Rx (50MG/10ML (5MG/ML)); 002 Rx (200MG/40ML (5MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMar 25, 2018Orphan Designation: Treatment of high risk Stage II, Stage III, and Stage IV melanoma
Approved Labeled Indication: Treatment of unresectable or metastatic melanoma
Exclusivity Type: Orphan Drug ExclusivityOct 28, 2022Orphan Designation: Treatment of high risk Stage II, Stage III, and Stage IV melanoma
Approved Labeled Indication: For the adjuvant treatment of patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm, who have undergone complete resection including total lymphadenectomy.
Exclusivity Protected Indication: For the adjuvant treatment of patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm, who have undergone complete resection including total lymphadenectomy.
Exclusivity Type: Orphan Drug ExclusivityJul 21, 2024Orphan Designation: Treatment of high risk Stage II, Stage III, and Stage IV melanoma
Approved Labeled Indication: treatment of unresectable or metastatic melanoma in adults and pediatric patients (12 years and older)
Exclusivity Protected Indication: treatment of unresectable or metastatic melanoma in pediatric patients (12 years and older).
Exclusivity Type: Orphan Drug ExclusivityOct 2, 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.

BTG International Inc.
Crofab (For Injection) (Intravenous) Crotalidae Polyvalent Immune Fab (Ovine)
NDA Applicant: BTG International Inc.      BLA No.: 103788  Prod. No.: 001 Rx (1G)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityOct 2, 2007Orphan Designation: Treatment of envenomations inflicted by North American crotalid snakes.
Approved Labeled Indication: Treatment of minimal and moderate North American Crotalidae envenomation

BTG International Inc.
Voraxaze (For Injection) (Intravenous) glucarpidase
Drug Classes: carboxypeptidase
NDA Applicant: BTG International Inc.      BLA No.: 125327  Prod. No.: 001 Rx (1,000UNITS)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJan 17, 2019Orphan Designation: Treatment of patients at risk of methotrexate toxicity
Approved Labeled Indication: Treatment of toxic (>1 micromole/liter) plasma methotrexate concentrations in patients with delayed methotrexate clearance due to impaired renal function.



Last edited: 15 November 2022
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