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.
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Feb 25, 2000 | Orphan Designation: This Orphan Designation could not be obtained via our automated process due to a trademark mismatch between the Purple Book and the FDA's "Orphan Drug Designations and Approvals" search engine. Please use the FDA's search engine to manually look up the orphan designation. |
Bayer HealthCare Pharmaceuticals Inc.
Betaseron (For Injection) (Subcutaneous) interferon beta-1b
NDA Applicant: Bayer HealthCare Pharmaceuticals Inc. BLA No.: 103471 Prod. No.: 001 Rx (0.3MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Jul 23, 2000 | Orphan 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
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))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Dec 29, 2000 | Orphan 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)
NDA Applicant: Bio Products Laboratory BLA No.: 125506 Prod. No.: 001 Rx (500IU); 002 Rx (250IU)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Oct 20, 2022 | Orphan 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 Exclusivity | Sep 21, 2025 | Orphan 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 |
| Exclusivity Type: Orphan Drug Exclusivity | Apr 14, 2030 | Orphan Designation: Treatment of hereditary factor X deficiency Approved Labeled Indication: 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, moderate, and severe hereditary Factor X deficiency Exclusivity Protected Indication: perioperative management of bleeding in adults and children with severe hereditary Factor X deficiency |
Biogen Inc.
Avonex (For Injection) (Intramuscular) interferon beta-1a
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)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | May 17, 2003 | Orphan 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
NDA Applicant: Biogen Inc. BLA No.: 125104 Prod. No.: 001 Rx (300MG/15ML (20MG/ML))
| Patents | Expiration | Patented 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, 2031 | |
| 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 | Jun 1, 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
NDA Applicant: BioMarin Pharmaceutical Inc. BLA No.: 125058 Prod. No.: 001 Rx (2.9MG/5ML (0.58MG/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Apr 30, 2010 | Orphan 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
NDA Applicant: BioMarin Pharmaceutical Inc. BLA No.: 761052 Prod. No.: 001 Rx (150MG/5ML (30MG/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Apr 27, 2024 | Orphan 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
NDA Applicant: BioMarin Pharmaceutical Inc. BLA No.: 125117 Prod. No.: 001 Rx (5MG/5ML (1MG/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | May 31, 2012 | Orphan Designation: This Orphan Designation could not be obtained via our automated process due to a trademark mismatch between the Purple Book and the FDA's "Orphan Drug Designations and Approvals" search engine. Please use the FDA's search engine to manually look up the orphan designation. |
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)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | May 24, 2025 | Orphan 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.
Roctavian (Injection) (Intravenous) valoctocogene roxaparvovec-rvox
NDA Applicant: Biomarin Pharmaceutical Inc. BLA No.: 125720 Prod. No.: 001 Rx (16X 10E13GENOMES PER ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Jun 29, 2030 | Orphan Designation: Treatment of Hemophilia A. Approved Labeled Indication: treatment of adults with severe hemophilia A (congenital factor VIII deficiency with factor VIII activity less than 1 IU/dL) without antibodies to adeno-associated virus serotype 5 (AAV5) detected by an FDA-approved test Exclusivity Protected Indication: treatment of adults with severe hemophilia A (congenital factor VIII deficiency with factor VIII activity less than 1 IU/dL) without antibodies to adeno-associated virus serotype 5 (AAV5) detected by an FDA-approved test |
BioMarin Pharmaceutical Inc.
Vimizim (Injection) (Intravenous) elosulfase alfa
NDA Applicant: BioMarin Pharmaceutical Inc. BLA No.: 125460 Prod. No.: 001 Rx (5MG/5ML (1MG/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Feb 14, 2021 | Orphan 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
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)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Mar 28, 2021 | Orphan 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.
ALTUVIIIO (For Injection) (Intravenous) antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl
NDA Applicant: Bioverativ Therapeutics, Inc. BLA No.: 125771 Prod. No.: 001 Rx (250IU); 002 Rx (500IU); 003 Rx (750IU); 004 Rx (1000IU); 005 Rx (2000IU); 006 Rx (3000IU); 007 Rx (4000IU)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Feb 22, 2030 | Orphan Designation: Treatment of hemophilia A Approved Labeled Indication: in adults and children with hemophilia A (congenital factor VIII deficiency) for routine prophylaxis to reduce the frequency of bleeding episodes; on-demand treatment and control of bleeding episodes; and perioperative management of bleeding Exclusivity Protected Indication: in adults and children with hemophilia A (congenital factor VIII deficiency) for routine prophylaxis to reduce the frequency of bleeding episodes; on-demand treatment and control of bleeding episodes; and perioperative management of bleeding |
Bioverativ Therapeutics, Inc.
Eloctate (For Injection) (Intravenous) Antihemophilic Factor (Recombinant), Fc Fusion protein
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)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Jun 6, 2021 | Orphan 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. |
Bioverativ Therapeutics, Inc.
Enjaymo (Injection) (Intravenous) sutimlimab-jome
NDA Applicant: Bioverativ Therapeutics, Inc. BLA No.: 761164 Prod. No.: 001 Rx (1,100MG/22ML (50MG/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Feb 4, 2029 | Orphan Designation: Treatment of autoimmune hemolytic anemia Approved Labeled Indication: To decrease the need for red blood cell (RBC) transfusion due to hemolysis in adults with cold agglutinin disease (CAD) Exclusivity Protected Indication: To decrease the need for red blood cell (RBC) transfusion due to hemolysis in adults with cold agglutinin disease (CAD) |
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)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Sep 16, 2029 | Orphan Designation: Treatment of andrenoleukodystrophy Approved Labeled Indication: To slow the progression of neurologic dysfunction in boys 4-17 years of age with early, active cerebral adrenoleukodystrophy (CALD) Exclusivity Protected Indication: To slow the progression of neurologic dysfunction in boys 4-17 years of age with early, active cerebral adrenoleukodystrophy (CALD) |
| Exclusivity Type: Ref. Product Exclusivity | Sep 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)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Aug 17, 2029 | Orphan Designation: Treatment of B-thalassemia major and intermedia Approved Labeled Indication: Treatment of adult and pediatric patients with beta-thalassemia who require regular red blood cell (RBC) transfusions Exclusivity Protected Indication: Treatment of adult and pediatric patients with beta-thalassemia who require regular red blood cell (RBC) transfusions |
| Exclusivity Type: Ref. Product Exclusivity | Aug 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); 004 Rx (40MG/0.8ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: 1st Interchangeable Exclusivity | Date TBD |
Boehringer Ingelheim Pharmaceuticals, Inc.
Praxbind (Injection) (Intravenous) idarucizumab
NDA Applicant: Boehringer Ingelheim Pharmaceuticals, Inc. BLA No.: 761025 Prod. No.: 001 Rx (2.5G/50ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Oct 16, 2022 | Orphan 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 |
Boehringer Ingelheim Pharmaceuticals, Inc.
Spevigo (Injection) (Intravenous) spesolimab-sbzo
NDA Applicant: Boehringer Ingelheim Pharmaceuticals, Inc. BLA No.: 761244 Prod. No.: 001 Rx (450MG/7.5ML (60MG/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Sep 1, 2029 | Orphan Designation: Treatment of generalized pustular psoriasis Approved Labeled Indication: Treatment of generalized pustular psoriasis (GPP) flares in adults Exclusivity Protected Indication: Treatment of generalized pustular psoriasis (GPP) flares in adults |
Bristol-Myers Squibb Company
Empliciti (For Injection) (Intravenous) elotuzumab
NDA Applicant: Bristol-Myers Squibb Company BLA No.: 761035 Prod. No.: 001 Rx (300MG); 002 Rx (400MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Nov 30, 2022 | Orphan 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 Exclusivity | Nov 6, 2025 | Orphan 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 Emplicitis previously approved indication for multiple myeloma. |
Bristol-Myers Squibb Company
Nulojix (For Injection) (Intravenous) belatacept
NDA Applicant: Bristol-Myers Squibb Company BLA No.: 125288 Prod. No.: 001 Rx (250MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Jun 15, 2018 | Orphan 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
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))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Dec 22, 2021 | Orphan 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 Exclusivity | May 17, 2023 | Orphan 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 Exclusivity | Apr 25, 2024 | Orphan 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 Exclusivity | Dec 20, 2024 | Orphan 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 Exclusivity | Jun 10, 2027 | Orphan 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 Exclusivity | Apr 16, 2028 | Orphan 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 Exclusivity | Apr 16, 2028 | Orphan 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 Exclusivity | May 20, 2028 | Orphan 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) |
| Exclusivity Type: Orphan Drug Exclusivity | May 20, 2028 | Orphan 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 Exclusivity | May 27, 2029 | Orphan Designation: Treatment of esophageal cancer Approved Labeled Indication: In combination with ipilimumab, for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) Exclusivity Protected Indication: First-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) |
| Exclusivity Type: Orphan Drug Exclusivity | May 27, 2029 | Orphan Designation: Treatment of esophageal cancer Approved Labeled Indication: In combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) Exclusivity Protected Indication: First-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) |
| Exclusivity Type: Orphan Drug Exclusivity | Feb 15, 2030 | Orphan Designation: Treatment of Stage IIb to IV melanoma Approved Labeled Indication: As a single agent or in combination with ipilimumab, for the treatment of adult and pediatric patients 12 years and older with unresectable or metastatic melanoma Exclusivity Protected Indication: Treatment of pediatric patients 12 years and older with unresectable or metastatic melanoma |
| Exclusivity Type: Orphan Drug Exclusivity | Feb 15, 2030 | Orphan Designation: Treatment of Stage IIb to IV melanoma Approved Labeled Indication: adjuvant treatment of adult and pediatric patients 12 years and older with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection Exclusivity Protected Indication: adjuvant treatment of pediatric patients 12 years and older with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection |
Bristol-Myers Squibb Company
Opdualag (Injection) (Intravenous) nivolumab and relatlimab-rmbw
NDA Applicant: Bristol-Myers Squibb Company BLA No.: 761234 Prod. No.: 001 Rx (240MG, 80MG/20ML (12MG, 4MG/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Mar 18, 2029 | Orphan Designation: Treatment of stage IIb to IV melanoma Approved Labeled Indication: Treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma Exclusivity Protected Indication: Treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma |
Bristol-Myers Squibb Company
Orencia (For Injection) (Intravenous; Subcutaneous) abatacept
NDA Applicant: Bristol-Myers Squibb Company BLA No.: 125118 Prod. No.: 001 Rx (250MG); 002 Rx (125MG/ML); 003 Rx (125MG/ML); 004 Rx (50MG/0.4ML); 005 Rx (87.5MG/0.7ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Dec 15, 2028 | Orphan Designation: Prevention of graft versus host disease Approved Labeled Indication: prophylaxis of acute graft versus host disease (aGVHD), in combination with a calcineurin inhibitor and methotrexate, in adults and pediatric patients 2 years of age and older undergoing hematopoietic stem cell transplantation (HSCT) from a matched or 1 allele-mismatched unrelated-donor Exclusivity Protected Indication: prophylaxis of acute graft versus host disease (aGVHD) in adults and pediatric patients 2 years of age and older undergoing hematopoietic stem cell transplantation (HSCT) from a matched or 1 allele-mismatched unrelated-donor |
Bristol-Myers Squibb Company
Yervoy (Injection) (Intravenous) ipilimumab
NDA Applicant: Bristol-Myers Squibb Company BLA No.: 125377 Prod. No.: 001 Rx (50MG/10ML (5MG/ML)); 002 Rx (200MG/40ML (5MG/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Mar 25, 2018 | Orphan 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 Exclusivity | Oct 28, 2022 | Orphan 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 Exclusivity | Jul 21, 2024 | Orphan 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 Exclusivity | Oct 2, 2027 | Orphan Designation: This Orphan Designation could not be obtained via our automated process due to a trademark mismatch between the Purple Book and the FDA's "Orphan Drug Designations and Approvals" search engine. Please use the FDA's search engine to manually look up the orphan designation. |
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)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Oct 2, 2007 | Orphan 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
NDA Applicant: BTG International Inc. BLA No.: 125327 Prod. No.: 001 Rx (1,000UNITS)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Jan 17, 2019 | Orphan 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. |