Generic names starting with "C"

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.

C1 Esterase Inhibitor (Human) (For Injection) (Intravenous) Cinryze
NDA Applicant: Takeda Pharmaceuticals U.S.A., Inc. BLA No.: 125267 Prod. No.: 001 Rx (500U)

Exclusivity	Expiration	Exclusivity Description
Exclusivity Type: Orphan Drug Exclusivity	Oct 10, 2015	Orphan Designation: Treatment of angioedema Approved Labeled Indication: Routine prophylaxis against angioedema attacks in patients with Hereditary Angioedema (HAE)
Exclusivity Type: Orphan Drug Exclusivity	Jun 20, 2025	Orphan Designation: Treatment of angioedema Approved Labeled Indication: CINRYZE is a C1 esterase inhibitor indicated for routine prophylaxis against angioedema attacks in adults, adolescents and pediatric patients (6 years old and above) with Hereditary Angioedema (HAE). Exclusivity Protected Indication: CINRYZE (C1 esterase inhibitor [human]) is indicated for routine prophylaxis against angioedema attacks in pediatric patients ages 6-11 with Hereditary Angioedema (HAE).

C1 Esterase Inhibitor (Human) (For Injection) (Intravenous) Berinert
NDA Applicant: CSL Behring GmbH BLA No.: 125287 Prod. No.: 001 Rx (500U)

Exclusivity Expiration Exclusivity Description

Exclusivity Type: Orphan Drug Exclusivity Oct 8, 2016 Orphan Designation: Prevention and/or treatment of acute attacks of hereditary angioedema.
Approved Labeled Indication: Treatment of acute attacks of hereditary angioedema.

Exclusivity	Expiration	Exclusivity Description
Exclusivity Type: Orphan Drug Exclusivity	Oct 8, 2016	Orphan Designation: Prevention and/or treatment of acute attacks of hereditary angioedema. Approved Labeled Indication: Treatment of acute attacks of hereditary angioedema.

C1 Esterase Inhibitor (Recombinant) (For Injection) (Intravenous) Ruconest
NDA Applicant: Pharming Americas BV BLA No.: 125495 Prod. No.: 001 Rx (2100IU)

Exclusivity Expiration Exclusivity Description

Exclusivity Type: Orphan Drug Exclusivity Jul 16, 2021 Orphan Designation: Treatment of (acute attacks of) angioedema caused by hereditary or acquired C1-esterase inhibitor deficiency.
Approved Labeled Indication: Treatment of acute attacks of hereditary angioedema (HAE) in adult and adolescent patients.
Exclusivity Protected Indication: Treatment of acute attacks of hereditary angioedema (HAE) in adult and adolescent patients.

Exclusivity Type: Ref. Product Exclusivity Jul 16, 2026

Exclusivity	Expiration	Exclusivity Description
Exclusivity Type: Orphan Drug Exclusivity	Jul 16, 2021	Orphan Designation: Treatment of (acute attacks of) angioedema caused by hereditary or acquired C1-esterase inhibitor deficiency. Approved Labeled Indication: Treatment of acute attacks of hereditary angioedema (HAE) in adult and adolescent patients. Exclusivity Protected Indication: Treatment of acute attacks of hereditary angioedema (HAE) in adult and adolescent patients.
Exclusivity Type: Ref. Product Exclusivity	Jul 16, 2026

C1 Esterase Inhibitor Subcutaneous (Human) (For Injection) (Subcutaneous) Haegarda
NDA Applicant: CSL Behring GmbH BLA No.: 125606 Prod. No.: 001 Rx (2000IU); 002 Rx (3000IU)

Exclusivity Expiration Exclusivity Description

Exclusivity Type: Orphan Drug Exclusivity Jun 22, 2024 Orphan Designation: Prevention and/or treatment of acute attacks of hereditary angioedema.
Approved Labeled Indication: For routine prophylaxis to prevent Hereditary Angioedema (HAE) attacks in adolescent and adult patients.
Exclusivity Protected Indication: For routine prophylaxis to prevent Hereditary Angioedema (HAE) attacks in adolescent and adult patients.

Exclusivity	Expiration	Exclusivity Description
Exclusivity Type: Orphan Drug Exclusivity	Jun 22, 2024	Orphan Designation: Prevention and/or treatment of acute attacks of hereditary angioedema. Approved Labeled Indication: For routine prophylaxis to prevent Hereditary Angioedema (HAE) attacks in adolescent and adult patients. Exclusivity Protected Indication: For routine prophylaxis to prevent Hereditary Angioedema (HAE) attacks in adolescent and adult patients.

calaspargase pegol-mknl (Injection) (Intravenous) Asparlas
NDA Applicant: Servier Pharmaceuticals LLC BLA No.: 761102 Prod. No.: 001 Rx (3,750UNITS/5ML (750UNITS/ML))

Exclusivity Expiration Exclusivity Description

Exclusivity Type: Orphan Drug Exclusivity Feb 1, 2001 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.

Exclusivity	Expiration	Exclusivity Description
Exclusivity Type: Orphan Drug Exclusivity	Feb 1, 2001	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.

canakinumab (For Injection) (Subcutaneous) Ilaris
NDA Applicant: Novartis Pharmaceuticals Corporation BLA No.: 125319 Prod. No.: 001 Rx (150MG); 002 Rx (150MG/ML)

Exclusivity Expiration Exclusivity Description

Exclusivity Type: Orphan Drug Exclusivity Jun 17, 2016 Orphan Designation: Treatment of cryopyrin-associated periodic syndromes
Approved Labeled Indication: Treatment of cryopyrin-associated periodic syndromes (CAPS), in adults and children 4 years of age and older.

Exclusivity Type: Orphan Drug Exclusivity May 9, 2020 Orphan Designation: Treatment of pediatric (age 16 and under) juvenile rheumatoid arthritis.
Approved Labeled Indication: Treatment of active Systemic Juvenile Idiopathic Arthritis (SJIA) in patients aged 2 years and older.
Exclusivity Protected Indication: Treatment of active Systemic Juvenile Idiopathic Arthritis (SJIA) in patients aged 2 through 16 years.

Exclusivity Type: Orphan Drug Exclusivity Sep 23, 2023 Orphan Designation: Treatment of familial mediterranean fever
Approved Labeled Indication: Indicated for treatment of Familial Mediterranean Fever (FMF) in adult and pediatric patients
Exclusivity Protected Indication: Indicated for treatment of Familial Mediterranean Fever (FMF) in adult and pediatric patients

Exclusivity Type: Orphan Drug Exclusivity Sep 23, 2023 Orphan Designation: Treatment of TNF-receptor associated periodic syndrome (TRAPS)
Approved Labeled Indication: Indicated for the treatment of Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS) in adult and pediatric patients
Exclusivity Protected Indication: Indicated for treatment of Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS) in adult and pediatric patients

Exclusivity Type: Orphan Drug Exclusivity Sep 23, 2023 Orphan Designation: Treatment of hyperimmunoglobulinemia D and periodic fever syndrome
Approved Labeled Indication: Indicated for Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD) in adult and pediatric patients
Exclusivity Protected Indication: Indicated for Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD) in adult and pediatric patients

Exclusivity Type: Orphan Drug Exclusivity Jun 16, 2027 Orphan Designation: Treatment of adult-onset Still's Disease
Approved Labeled Indication: ILARIS is indicated for the treatment of active Stills disease, including Adult-Onset Stills Disease (AOSD) and Systemic Juvenile Idiopathic Arthritis (SJIA) in patients aged 2 years and older.
Exclusivity Protected Indication: For the treatment of active adult-onset Stills Disease (AOSD).

Exclusivity	Expiration	Exclusivity Description
Exclusivity Type: Orphan Drug Exclusivity	Jun 17, 2016	Orphan Designation: Treatment of cryopyrin-associated periodic syndromes Approved Labeled Indication: Treatment of cryopyrin-associated periodic syndromes (CAPS), in adults and children 4 years of age and older.
Exclusivity Type: Orphan Drug Exclusivity	May 9, 2020	Orphan Designation: Treatment of pediatric (age 16 and under) juvenile rheumatoid arthritis. Approved Labeled Indication: Treatment of active Systemic Juvenile Idiopathic Arthritis (SJIA) in patients aged 2 years and older. Exclusivity Protected Indication: Treatment of active Systemic Juvenile Idiopathic Arthritis (SJIA) in patients aged 2 through 16 years.
Exclusivity Type: Orphan Drug Exclusivity	Sep 23, 2023	Orphan Designation: Treatment of familial mediterranean fever Approved Labeled Indication: Indicated for treatment of Familial Mediterranean Fever (FMF) in adult and pediatric patients Exclusivity Protected Indication: Indicated for treatment of Familial Mediterranean Fever (FMF) in adult and pediatric patients
Exclusivity Type: Orphan Drug Exclusivity	Sep 23, 2023	Orphan Designation: Treatment of TNF-receptor associated periodic syndrome (TRAPS) Approved Labeled Indication: Indicated for the treatment of Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS) in adult and pediatric patients Exclusivity Protected Indication: Indicated for treatment of Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS) in adult and pediatric patients
Exclusivity Type: Orphan Drug Exclusivity	Sep 23, 2023	Orphan Designation: Treatment of hyperimmunoglobulinemia D and periodic fever syndrome Approved Labeled Indication: Indicated for Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD) in adult and pediatric patients Exclusivity Protected Indication: Indicated for Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD) in adult and pediatric patients
Exclusivity Type: Orphan Drug Exclusivity	Jun 16, 2027	Orphan Designation: Treatment of adult-onset Still's Disease Approved Labeled Indication: ILARIS is indicated for the treatment of active Stills disease, including Adult-Onset Stills Disease (AOSD) and Systemic Juvenile Idiopathic Arthritis (SJIA) in patients aged 2 years and older. Exclusivity Protected Indication: For the treatment of active adult-onset Stills Disease (AOSD).

caplacizumab-yhdp (For injection) (Intravenous, Subcutaneous ) Cablivi
NDA Applicant: Ablynx NV BLA No.: 761112 Prod. No.: 001 Rx (11MG)

Exclusivity Expiration Exclusivity Description

Exclusivity Type: Orphan Drug Exclusivity Feb 6, 2026 Orphan Designation: Treatment of thrombotic thrombocytopenic purpura
Approved Labeled Indication: CABLIVI is indicated for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura (aTTP), in combination with plasma exchange and immunosuppressive therapy.
Exclusivity Protected Indication: CABLIVI is indicated for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura (aTTP), in combination with plasma exchange and immunosuppressive therapy.

Exclusivity	Expiration	Exclusivity Description
Exclusivity Type: Orphan Drug Exclusivity	Feb 6, 2026	Orphan Designation: Treatment of thrombotic thrombocytopenic purpura Approved Labeled Indication: CABLIVI is indicated for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura (aTTP), in combination with plasma exchange and immunosuppressive therapy. Exclusivity Protected Indication: CABLIVI is indicated for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura (aTTP), in combination with plasma exchange and immunosuppressive therapy.

cenegermin-bkbj (Solution) (Topical) Oxervate
NDA Applicant: Domp� farmaceutici S.p.A. BLA No.: 761094 Prod. No.: 001 Rx (0.002% (20MCG/ML))

Exclusivity Expiration Exclusivity Description

Exclusivity Type: Orphan Drug Exclusivity Aug 22, 2025 Orphan Designation: Treatment of neurotrophic keratitis
Approved Labeled Indication: Treatment of neurotrophic keratitis
Exclusivity Protected Indication: Treatment of neurotrophic keratitis

Exclusivity	Expiration	Exclusivity Description
Exclusivity Type: Orphan Drug Exclusivity	Aug 22, 2025	Orphan Designation: Treatment of neurotrophic keratitis Approved Labeled Indication: Treatment of neurotrophic keratitis Exclusivity Protected Indication: Treatment of neurotrophic keratitis

Centruroides (Scorpion) Immune F(ab')2 (Equine) Injection (For Injection) (Intravenous) Anascorp
NDA Applicant: Rare Disease Therapeutics, Inc. (RDT) BLA No.: 125335 Prod. No.: 001 Rx (>/=150 LD50 NEUTRALIZING UNITS)

Exclusivity Expiration Exclusivity Description

Exclusivity Type: Orphan Drug Exclusivity Aug 4, 2018 Orphan Designation: Treatment of scorpion envenomations requiring medical attention.
Approved Labeled Indication: Treatment of clinical signs of scorpion envenomation

Exclusivity	Expiration	Exclusivity Description
Exclusivity Type: Orphan Drug Exclusivity	Aug 4, 2018	Orphan Designation: Treatment of scorpion envenomations requiring medical attention. Approved Labeled Indication: Treatment of clinical signs of scorpion envenomation

cerliponase alfa (Injection) (Intraventricular) Brineura
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.

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.

cetuximab (Injection) (Intravenous) Erbitux
NDA Applicant: Eli Lilly and Company BLA No.: 125084 Prod. No.: 001 Rx (100MG/50ML (2MG/ML)); 002 Rx (200MG/100ML (2MG/ML))

Exclusivity Expiration Exclusivity Description

Exclusivity Type: Orphan Drug Exclusivity Mar 1, 2013 Orphan Designation: Treatment of squamous cell cancer of the head and neck in patients who express epidermal growth factor receptor
Approved Labeled Indication: For use in combination with radiation therapy, for the treatment of locally or regionally advanced squamous cell carcinoma of the head and neck (SCCHN) and for use as a single agent for the treatment of patients with recurrent or metastatic SCCHN for whom prior platinum-based therapy has failed

Exclusivity	Expiration	Exclusivity Description
Exclusivity Type: Orphan Drug Exclusivity	Mar 1, 2013	Orphan Designation: Treatment of squamous cell cancer of the head and neck in patients who express epidermal growth factor receptor Approved Labeled Indication: For use in combination with radiation therapy, for the treatment of locally or regionally advanced squamous cell carcinoma of the head and neck (SCCHN) and for use as a single agent for the treatment of patients with recurrent or metastatic SCCHN for whom prior platinum-based therapy has failed

ciltacabtagene autoleucel (For Injection) (Intravenous) Carvykti
NDA Applicant: Janssen Biotech, Inc. BLA No.: 125746 Prod. No.: 001 Rx (0.5 to 1.0x10^6 chimeric antigen receptor (CAR)-positive viable T cells per kg of body weight, with a maximum dose of 1x10^8 CAR-positive viable T cells in one infusion)

Exclusivity Expiration Exclusivity Description

Exclusivity Type: Orphan Drug Exclusivity Feb 28, 2029 Orphan Designation: Treatment of multiple myeloma (MM)
Approved Labeled Indication: Treatment of adult patients with relapsed or refractory multiple myeloma, after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, 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 a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody

Exclusivity Type: Ref. Product Exclusivity Feb 28, 2034

Exclusivity	Expiration	Exclusivity Description
Exclusivity Type: Orphan Drug Exclusivity	Feb 28, 2029	Orphan Designation: Treatment of multiple myeloma (MM) Approved Labeled Indication: Treatment of adult patients with relapsed or refractory multiple myeloma, after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, 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 a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody
Exclusivity Type: Ref. Product Exclusivity	Feb 28, 2034

Coagulation Factor IX (Human) (Injection) (Intravenous) Alphanine, Alphanine Hp, Alphanine Sd
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)

Exclusivity Expiration Exclusivity Description

Exclusivity Type: Orphan Drug Exclusivity Dec 31, 1997 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.

Exclusivity	Expiration	Exclusivity Description
Exclusivity Type: Orphan Drug Exclusivity	Dec 31, 1997	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.

Coagulation Factor IX (Human) (For Injection) (Intravenous) Mononine
NDA Applicant: CSL Behring LLC BLA No.: 103957 Prod. No.: 001 Disc (1000IU); 002 Disc (500IU)

Exclusivity Expiration Exclusivity Description

Exclusivity Type: Orphan Drug Exclusivity Aug 20, 1999 Orphan Designation: Replacement treatment and prophylaxis of the hemorrhagic complications of hemophilia B.
Approved Labeled Indication: Prevention and control of bleeding in factor IX deficiency, also known as hemophilia B or Christmas disease.

Exclusivity	Expiration	Exclusivity Description
Exclusivity Type: Orphan Drug Exclusivity	Aug 20, 1999	Orphan Designation: Replacement treatment and prophylaxis of the hemorrhagic complications of hemophilia B. Approved Labeled Indication: Prevention and control of bleeding in factor IX deficiency, also known as hemophilia B or Christmas disease.

Coagulation Factor IX (Recombinant) (For Injection) (Intravenous) Benefix
NDA Applicant: Wyeth Pharmaceuticals LLC BLA No.: 103677 Prod. No.: 001 Rx (1000IU/ML); 002 Rx (500IU/ML); 003 Rx (250IU/ML); 004 Rx (2000IU/ML); 005 Rx (3000IU/ML)

Exclusivity Expiration Exclusivity Description

Exclusivity Type: Orphan Drug Exclusivity Feb 11, 2004 Orphan Designation: Treatment of hemophilia B
Approved Labeled Indication: For the control and prevention of hemorrhagic episodes in patients with hemophilia B (congenital factor IX deficiency and Christmas disease), including control and prevention of bleeding in surgical settings.

Exclusivity	Expiration	Exclusivity Description
Exclusivity Type: Orphan Drug Exclusivity	Feb 11, 2004	Orphan Designation: Treatment of hemophilia B Approved Labeled Indication: For the control and prevention of hemorrhagic episodes in patients with hemophilia B (congenital factor IX deficiency and Christmas disease), including control and prevention of bleeding in surgical settings.

Coagulation Factor IX (Recombinant) (For Injection) (Intravenous) Rixubis
NDA Applicant: Takeda Pharmaceuticals U.S.A., Inc. BLA No.: 125446 Prod. No.: 001 Rx (500IU); 002 Rx (1000IU); 003 Rx (250IU); 004 Rx (3000IU); 005 Rx (2000IU)

Exclusivity Expiration Exclusivity Description

Exclusivity Type: Orphan Drug Exclusivity Sep 12, 2021 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.

Exclusivity	Expiration	Exclusivity Description
Exclusivity Type: Orphan Drug Exclusivity	Sep 12, 2021	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.

Coagulation Factor IX (Recombinant), Albumin Fusion Protein (For Injection) (Intravenous) Idelvion
NDA Applicant: CSL Behring Lengnau AG BLA No.: 125582 Prod. No.: 001 Rx (500IU); 002 Rx (1000IU); 003 Rx (2000IU); 004 Rx (250IU); 005 Rx (3500IU)

Exclusivity Expiration Exclusivity Description

Exclusivity Type: Orphan Drug Exclusivity Mar 4, 2023 Orphan Designation: Treatment of patients with congenital factor IX deficiency (hemophilia B).
Approved Labeled Indication: Indicated in children and adults with hemophilia B (congenital Factor IX deficiency) for the (1) on-demand control and prevention of bleeding episodes, (2) perioperative management of bleeding, and (3) routine prophylaxis to prevent or reduce the frequency of bleeding episodes.
Exclusivity Protected Indication: Indicated for the (1) on-demand control and prevention of bleeding episodes, (2) perioperative management of bleeding, and (3) routine prophylaxis to prevent or reduce the frequency of bleeding episodes.

Exclusivity	Expiration	Exclusivity Description
Exclusivity Type: Orphan Drug Exclusivity	Mar 4, 2023	Orphan Designation: Treatment of patients with congenital factor IX deficiency (hemophilia B). Approved Labeled Indication: Indicated in children and adults with hemophilia B (congenital Factor IX deficiency) for the (1) on-demand control and prevention of bleeding episodes, (2) perioperative management of bleeding, and (3) routine prophylaxis to prevent or reduce the frequency of bleeding episodes. Exclusivity Protected Indication: Indicated for the (1) on-demand control and prevention of bleeding episodes, (2) perioperative management of bleeding, and (3) routine prophylaxis to prevent or reduce the frequency of bleeding episodes.

Coagulation Factor IX (Recombinant), Fc Fusion Protein (For Injection) (Intravenous) Alprolix
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.

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.

Coagulation Factor VIIa (Recombinant) (For Injection) (Intravenous) Novoseven, Novoseven Rt
NDA Applicant: Novo Nordisk Inc. BLA No.: 103665 Prod. No.: 004 Rx (5.0MG); 005 Rx (1.0MG); 006 Rx (2.0MG); 007 Rx (8.0MG) BLA No.: 103665 Prod. No.: 001 Disc (2.4MG); 002 Disc (1.2MG); 003 Disc (4.8MG)

Exclusivity Expiration Exclusivity Description

Exclusivity Type: Orphan Drug Exclusivity Jul 2, 2021 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.

Exclusivity	Expiration	Exclusivity Description
Exclusivity Type: Orphan Drug Exclusivity	Jul 2, 2021	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.

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

Coagulation Factor Xa (Recombinant), Inactivated-zhzo (Injection) (Intravenous) Andexxa
NDA Applicant: AstraZeneca AB BLA No.: 125586 Prod. No.: 001 Rx (100MG); 002 Rx (200MG)

Exclusivity Expiration Exclusivity Description

Exclusivity Type: Orphan Drug Exclusivity May 3, 2025 Orphan 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

Exclusivity	Expiration	Exclusivity Description
Exclusivity Type: Orphan Drug Exclusivity	May 3, 2025	Orphan 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

Coagulation Factor XIII A-Subunit (Recombinant) (For Injection) (Intravenous) Tretten
NDA Applicant: Novo Nordisk Inc. BLA No.: 125398 Prod. No.: 001 Rx (2000 - 3125IU)

Exclusivity Expiration Exclusivity Description

Exclusivity Type: Orphan Drug Exclusivity Dec 23, 2020 Orphan Designation: Prophylaxis of bleeding associated with congential factor XIII deficiency
Approved Labeled Indication: Routine prophylaxis of bleeding in patients with congenital Factor XIII A-subunit deficiency.
Exclusivity Protected Indication: Routine prophylaxis of bleeding in patients with congenital Factor XIII A-subunit deficiency.

Exclusivity	Expiration	Exclusivity Description
Exclusivity Type: Orphan Drug Exclusivity	Dec 23, 2020	Orphan Designation: Prophylaxis of bleeding associated with congential factor XIII deficiency Approved Labeled Indication: Routine prophylaxis of bleeding in patients with congenital Factor XIII A-subunit deficiency. Exclusivity Protected Indication: Routine prophylaxis of bleeding in patients with congenital Factor XIII A-subunit deficiency.

collagenase clostridium histolyticum (For Injection) (Intralesional) Xiaflex
NDA Applicant: Auxilium Pharmaceuticals, Inc. BLA No.: 125338 Prod. No.: 001 Rx (0.9MG)

Exclusivity Expiration Exclusivity Description

Exclusivity Type: Orphan Drug Exclusivity Feb 2, 2017 Orphan Designation: Treatment of advanced (involutional or residual stage) Dupuytren's disease
Approved Labeled Indication: Treatment of adult patients with Dupuytren's contracture with a palpable cord

Exclusivity Type: Orphan Drug Exclusivity Dec 6, 2020 Orphan Designation: Treatment of Peyronie's disease.
Approved Labeled Indication: Treatment of adult men with Peyronie's disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy.
Exclusivity Protected Indication: Treatment of adult men with Peyronie's disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy.

Exclusivity	Expiration	Exclusivity Description
Exclusivity Type: Orphan Drug Exclusivity	Feb 2, 2017	Orphan Designation: Treatment of advanced (involutional or residual stage) Dupuytren's disease Approved Labeled Indication: Treatment of adult patients with Dupuytren's contracture with a palpable cord
Exclusivity Type: Orphan Drug Exclusivity	Dec 6, 2020	Orphan Designation: Treatment of Peyronie's disease. Approved Labeled Indication: Treatment of adult men with Peyronie's disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy. Exclusivity Protected Indication: Treatment of adult men with Peyronie's disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy.

corticorelin ovine triflutate (For Injection) (Intravenous) Acthrel
NDA Applicant: Ferring Pharmaceuticals Inc. BLA No.: 020162 Prod. No.: 001 Disc (100MCG)

Exclusivity Expiration Exclusivity Description

Exclusivity Type: Orphan Drug Exclusivity May 23, 2003 Orphan 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.

Exclusivity	Expiration	Exclusivity Description
Exclusivity Type: Orphan Drug Exclusivity	May 23, 2003	Orphan 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.

crizanlizumab-tmca (Injection) (Intravenous) Adakveo
NDA Applicant: Novartis Pharmaceuticals Corporation BLA No.: 761128 Prod. No.: 001 Rx (100MG/10ML (10MG/ML))

Exclusivity Expiration Exclusivity Description

Exclusivity Type: Orphan Drug Exclusivity Nov 15, 2026 Orphan 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.

Exclusivity	Expiration	Exclusivity Description
Exclusivity Type: Orphan Drug Exclusivity	Nov 15, 2026	Orphan 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.

Crotalidae Immune F(ab')2 (Equine) (For Injection) (Intravenous) Anavip
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)

Exclusivity Expiration Exclusivity Description

Exclusivity Type: Orphan Drug Exclusivity May 6, 2022 Orphan 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

Exclusivity	Expiration	Exclusivity Description
Exclusivity Type: Orphan Drug Exclusivity	May 6, 2022	Orphan 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

Crotalidae Polyvalent Immune Fab (Ovine) (For Injection) (Intravenous) Crofab
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

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

Cytomegalovirus Immune Globulin Intravenous (Human) (Injection) (Intravenous) Cytogam
NDA Applicant: Kamada Ltd. BLA No.: 103189 Prod. No.: 001 Rx (2.5G/50ML)

Exclusivity Expiration Exclusivity Description

Exclusivity Type: Orphan Drug Exclusivity Dec 4, 2005 Orphan Designation: Prevention or attenuation of primary cytomegalovirus disease in immunosuppressed recipients of organ transplants.
Approved Labeled Indication: #1) Attenuation of primary CMV disease associated with kidney transplant recipients who are seronegative for CMV and who receive a kidney from a CMV seropositve donor; #2) Prophylaxis of CMV disease associated transplantation of kidney (all other), lung, liver, pancreas and heart.

Exclusivity Type: Orphan Drug Exclusivity Oct 4, 2005 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.

Exclusivity	Expiration	Exclusivity Description
Exclusivity Type: Orphan Drug Exclusivity	Dec 4, 2005	Orphan Designation: Prevention or attenuation of primary cytomegalovirus disease in immunosuppressed recipients of organ transplants. Approved Labeled Indication: #1) Attenuation of primary CMV disease associated with kidney transplant recipients who are seronegative for CMV and who receive a kidney from a CMV seropositve donor; #2) Prophylaxis of CMV disease associated transplantation of kidney (all other), lung, liver, pancreas and heart.
Exclusivity Type: Orphan Drug Exclusivity	Oct 4, 2005	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.