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
Drug Classes: Immunological Agents:Angioedema Agents
NDA Applicant: ViroPharma Biologics LLC      BLA No.: 125267  Prod. No.: 001 Rx (500U)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityOct 10, 2015Orphan Designation: Treatment of angioedema
Approved Labeled Indication: Routine prophylaxis against angioedema attacks in patients with Hereditary Angioedema (HAE)
Exclusivity Type: Orphan Drug ExclusivityJun 20, 2025Orphan 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
Drug Classes: Immunological Agents:Angioedema Agents
NDA Applicant: CSL Behring GmbH      BLA No.: 125287  Prod. No.: 001 Rx (500U)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityOct 8, 2016Orphan 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
Drug Classes: Immunological Agents:Angioedema Agents
NDA Applicant: Pharming Americas BV      BLA No.: 125495  Prod. No.: 001 Rx (2100IU)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJul 16, 2021Orphan 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 ExclusivityJul 16, 2026 

C1 Esterase Inhibitor Subcutaneous (Human) (For Injection) (Subcutaneous) Haegarda
Drug Classes: Immunological Agents:Angioedema Agents
NDA Applicant: CSL Behring GmbH      BLA No.: 125606  Prod. No.: 001 Rx (2000IU); 002 Rx (3000IU)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJun 22, 2024Orphan 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
Drug Classes: Antineoplastics:Antineoplastics, Other == asparagine specific enzyme
NDA Applicant: Servier Pharmaceuticals LLC      BLA No.: 761102  Prod. No.: 001 Rx (3,750UNITS/5ML (750UNITS/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityFeb 1, 2001Orphan Designation: This Orphan Designation could not be obtained via our automated process due to a trademark mismatch between the Purple Book and the FDA's "Orphan Drug Designations and Approvals" search engine. Please use the FDA's search engine to manually look up the orphan designation.

canakinumab (For Injection) (Subcutaneous) Ilaris
Drug Classes: Immunological Agents:Immunological Agents, Other
NDA Applicant: Novartis Pharmaceuticals Corporation      BLA No.: 125319  Prod. No.: 002 Rx (150MG/ML) BLA No.: 125319  Prod. No.: 001 Disc (150MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJun 17, 2016Orphan 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 ExclusivityMay 9, 2020Orphan 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 ExclusivitySep 23, 2023Orphan 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 ExclusivitySep 23, 2023Orphan 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 ExclusivitySep 23, 2023Orphan 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 ExclusivityJun 16, 2027Orphan Designation: Treatment of adult-onset Still's Disease
Approved Labeled Indication: ILARIS is indicated for the treatment of active Still_s disease, including Adult-Onset Still_s 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 Still_s Disease (AOSD).

caplacizumab-yhdp (For injection) (Intravenous, Subcutaneous ) Cablivi
NDA Applicant: Ablynx NV      BLA No.: 761112  Prod. No.: 001 Rx (11MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityFeb 6, 2026Orphan Designation: Treatment of thrombotic thrombocytopenic purpura
Approved Labeled Indication: CABLIVI is indicated for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura (aTTP), in combination with plasma exchange and immunosuppressive therapy.
Exclusivity Protected Indication: CABLIVI is indicated for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura (aTTP), in combination with plasma exchange and immunosuppressive therapy.

cenegermin-bkbj (Solution) (Topical) Oxervate
NDA Applicant: DompĂ© farmaceutici S.p.A.      BLA No.: 761094  Prod. No.: 001 Rx (0.002% (20MCG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityAug 22, 2025Orphan 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
Drug Classes: antivenin
NDA Applicant: Rare Disease Therapeutics, Inc. (RDT)      BLA No.: 125335  Prod. No.: 001 Rx (>/=150 LD50 NEUTRALIZING UNITS)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityAug 4, 2018Orphan Designation: Treatment of scorpion envenomations requiring medical attention.
Approved Labeled Indication: Treatment of clinical signs of scorpion envenomation

cerliponase alfa (Injection) (Intraventricular) Brineura
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.

cetuximab (Injection) (Intravenous) Erbitux
Drug Classes: Antineoplastics:Monoclonal Antibody/Antibody-Drug Conjugate == epidermal growth factor receptor (EGFR) antagonist
NDA Applicant: Eli Lilly and Company      BLA No.: 125084  Prod. No.: 001 Rx (100MG/50ML (2MG/ML)); 002 Rx (200MG/100ML (2MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMar 1, 2013Orphan 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

Coagulation Factor IX (Human) (Injection) (Intravenous) Alphanine, Alphanine Hp, Alphanine Sd
Drug Classes: Blood Products and Modifiers:Blood Component Deficiency/ Replacement == human blood coagulation factor ==
NDA Applicant: Grifols Biologicals LLC      BLA No.: 103249  Prod. No.: 001 Rx (500IU); 002 Rx (1000IU); 004 Rx (1500IU) BLA No.: 103249  Prod. No.: 003 Disc (250IU)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityDec 31, 1997Orphan Designation: This Orphan Designation could not be obtained via our automated process due to a trademark mismatch between the Purple Book and the FDA's "Orphan Drug Designations and Approvals" search engine. Please use the FDA's search engine to manually look up the orphan designation.

Coagulation Factor IX (Human) (For Injection) (Intravenous) Mononine
Drug Classes: Blood Products and Modifiers:Blood Component Deficiency/ Replacement == human blood coagulation factor ==
NDA Applicant: CSL Behring LLC      BLA No.: 103957  Prod. No.: 001 Rx (1000IU); 002 Rx (500IU)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityAug 20, 1999Orphan 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) Rixubis
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.

Coagulation Factor IX (Recombinant), Albumin Fusion Protein (For Injection) (Intravenous) Idelvion
Drug Classes: Blood Products and Modifiers:Blood Component Deficiency/ Replacement == human blood coagulation factor ==
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)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMar 4, 2023Orphan 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
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.

Coagulation Factor VIIa (Recombinant) (For Injection) (Intravenous) Novoseven, Novoseven Rt
Drug Classes: Blood Products and Modifiers:Blood Component Deficiency/ Replacement == human blood coagulation factor ==
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)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJul 2, 2021Orphan 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 X (Human) (For Injection) (Intravenous) Coagadex
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

Coagulation Factor Xa (Recombinant), Inactivated-zhzo (Injection) (Intravenous) Andexxa
Drug Classes: Blood Products and Modifiers:Blood Component Deficiency/ Replacement == human blood coagulation factor ==
NDA Applicant: AstraZeneca AB      BLA No.: 125586  Prod. No.: 001 Rx (100MG); 002 Rx (200MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMay 3, 2025Orphan Designation: For reversing the anticoagulant effect of direct or indirect factor Xa inhibitors in patients experiencing a serious uncontrolled bleeding event or who require urgent or emergent surgery
Approved Labeled Indication: Coagulation factor Xa (recombinant), inactivated-zhzo is indicated for patients treated with rivaroxaban and apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding
Exclusivity Protected Indication: Coagulation factor Xa (recombinant), inactivated-zhzo is indicated for patients treated with rivaroxaban and apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding

Coagulation Factor XIII A-Subunit (Recombinant) (For Injection) (Intravenous) Tretten
Drug Classes: Blood Products and Modifiers:Blood Component Deficiency/ Replacement == human blood coagulation factor ==
NDA Applicant: Novo Nordisk Inc.      BLA No.: 125398  Prod. No.: 001 Rx (2000 - 3125IU)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityDec 23, 2020Orphan 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
Drug Classes: Dermatological Agents:Dermatological Agents, Other == collagen-specific enzyme
NDA Applicant: Auxilium Pharmaceuticals, Inc.      BLA No.: 125338  Prod. No.: 001 Rx (0.9MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityFeb 2, 2017Orphan Designation: Treatment of advanced (involutional or residual stage) Dupuytren's disease
Approved Labeled Indication: Treatment of adult patients with Dupuytren's contracture with a palpable cord
Exclusivity Type: Orphan Drug ExclusivityDec 6, 2020Orphan Designation: Treatment of Peyronie's disease.
Approved Labeled Indication: Treatment of adult men with Peyronie's disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy.
Exclusivity Protected Indication: Treatment of adult men with Peyronie's disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy.

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

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

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)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMay 6, 2022Orphan Designation: Treatment of envenomation by Crotaline snakes
Approved Labeled Indication: Management of adult and pediatric patients with North American rattlesnake envenomation
Exclusivity Protected Indication: Management of adult and pediatric patients with North American rattlesnake envenomation

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

Cytomegalovirus Immune Globulin Intravenous (Human) (Injection) (Intravenous) Cytogam
Drug Classes: Immunological Agents:Immunoglobulins
NDA Applicant: Kamada Ltd.      BLA No.: 103189  Prod. No.: 001 Rx (2.5G/50ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityDec 4, 2005Orphan 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 ExclusivityOct 4, 2005Orphan 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.



Last edited: 15 November 2022
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