Tradenames starting with "C"

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


Cablivi (For injection) (Intravenous, Subcutaneous ) caplacizumab-yhdp
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.

Campath; Lemtrada (Injection) (Intravenous) alemtuzumab
Drug Classes: Central Nervous System Agents:Multiple Sclerosis Agents == CD52-directed cytolytic monoclonal antibody
NDA Applicant: Genzyme Corporation      BLA No.: 103948  Prod. No.: 002 Rx (12MG/1.2ML (10MG/ML)); 003 Rx (30MG/1ML) BLA No.: 103948  Prod. No.: 001 Disc (30MG (10MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMay 7, 2008Orphan Designation: Treatment of chronic lymphocytic leukemia.
Approved Labeled Indication: The treatment of patients with B-cell chronic lymphocytic leukemia who have been treated with alkylating agents and who have failed fludarabine therapy.

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

Cerezyme (For Injection) (Intravenous) imiglucerase
Drug Classes: Genetic, Enzyme, or Protein Disorder: Replacement, Modifiers, Treatment == hydrolytic lysozomal glucocerebroside-specific enzyme
NDA Applicant: Genzyme Corporation      BLA No.: 020367  Prod. No.: 002 Rx (400UNITS/VIAL) BLA No.: 020367  Prod. No.: 001 Disc (200UNITS/VIAL)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMay 23, 2001Orphan Designation: Replacement therapy in patients with types I, II, and III Gaucher's disease.
Approved Labeled Indication: Enzyme replacement therapy in patients with type I Gaucher's disease.

Cimerli (Injection) (Intravitreal) ranibizumab-eqrn
NDA Applicant: Coherus BioSciences, Inc.      BLA No.: 761165  Prod. No.: 001 Rx (10MG/ML (0.5MG/0.05ML)); 002 Rx (6MG/ML (0.3MG/0.05ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: 1st Interchangeable ExclusivityDate TBD 

Cinryze (For Injection) (Intravenous) C1 Esterase Inhibitor (Human)
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).

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

Corifact (For Injection) (Intravenous) Factor XIII Concentrate (Human)
Drug Classes: Blood Products and Modifiers:Blood Component Deficiency/ Replacement == human blood coagulation factor
NDA Applicant: CSL Behring GmbH      BLA No.: 125385  Prod. No.: 001 Rx (1000-1600IU)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityFeb 17, 2018Orphan Designation: Treatment of congenital factor XIII deficiency
Approved Labeled Indication: For the routine prophylactic treatment of congenital factor XIII deficiency
Exclusivity Type: Orphan Drug ExclusivityJan 24, 2020Orphan Designation: Treatment of congenital factor XIII deficiency
Approved Labeled Indication: Indicated for routine prophylactic treatment and peri-operative management of surgical bleeding in adult and pediatric patients with congenital FXIII deficiency.
Exclusivity Protected Indication: Peri-operative management of surgical bleeding in adult and pediatric patients with congenital Factor XIII deficiency.

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

Crysvita (Injection) (Subcutaneous) burosumab-twza
NDA Applicant: Kyowa Kirin, Inc.      BLA No.: 761068  Prod. No.: 001 Rx (10MG/ML); 002 Rx (20MG/ML); 003 Rx (30MG/ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityApr 17, 2025Orphan Designation: Treatment of X-linked hypophosphatemia (formerly known as vitamin D-resistant rickets)
Approved Labeled Indication: CRYSVITA is indicated for the treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients 1 year of age and older
Exclusivity Protected Indication: CRYSVITA is indicated for the treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients 1 year of age and older
Exclusivity Type: Orphan Drug ExclusivitySep 27, 2026Orphan Designation: Treatment of X-linked hypophosphatemia (formerly known as vitamin D-resistant rickets)
Approved Labeled Indication: CRYSVITA is indicated for the treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients 6 months of age and older.
Exclusivity Protected Indication: For the treatment of X-linked hypophosphatemia (XLH) in pediatric patients 6 months of age to less than 1 year of age
Exclusivity Type: Orphan Drug ExclusivityJun 18, 2027Orphan Designation: Treatment of tumor-induced osteomalacia (TIO) syndrome
Approved Labeled Indication: Crysvita (burosumab-twza) is indicated for the treatment of FGF23-related hypophosphatemia in tumor-induced osteomalacia (TIO) associated with phosphaturic mesenchymal tumors that cannot be curatively resected or localized.
Exclusivity Protected Indication: For the treatment of FGF23-related hypophosphatemia in tumor-induced osteomalacia (TIO) associated with phosphaturic mesenchymal tumors that cannot be curatively resected or localized in adult and pediatric patients 2 years of age and older

Cyltezo (Injection) (Subcutaneous) adalimumab-adbm
NDA Applicant: Boehringer Ingelheim Pharmaceuticals, Inc.      BLA No.: 761058  Prod. No.: 001 Rx (40MG/0.8ML); 002 Rx (20MG/0.4ML); 003 Rx (10MG/0.2ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: 1st Interchangeable ExclusivityDate TBD 

Cyramza (Injection) (Intravenous) ramucirumab
Drug Classes: Antineoplastics:Monoclonal Antibody/Antibody-Drug Conjugate == human vascular endothelial growth factor receptor 2 (VEGFR2) antagonist
NDA Applicant: Eli Lilly and Company      BLA No.: 125477  Prod. No.: 001 Rx (100MG/10ML (10MG/ML)); 002 Rx (500MG/50ML (10MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityApr 21, 2021Orphan Designation: Treatment of gastric cancer
Approved Labeled Indication: CYRAMZA as a single-agent is indicated for the treatment of patients with advanced or metastatic, gastric or gastro-esophageal junction adenocarcinoma with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy.
Exclusivity Protected Indication: Treatment of advanced gastric cancer or gastro-esophageal junction adenocarcinoma, as a single-agent after prior fluoropyrimidine-or platinum-containing therapy.
Exclusivity Type: Orphan Drug ExclusivityMay 10, 2026Orphan Designation: Treatment of hepatocellular carcinoma
Approved Labeled Indication: CYRAMZA, as a single agent, is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have an alpha fetoprotein (AFP) of >=400 ng/mL and have been treated with sorafenib.
Exclusivity Protected Indication: CYRAMZA, as a single agent, is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have an alpha fetoprotein (AFP) of >=400 ng/mL and have been treated with sorafenib.

Cytogam (Injection) (Intravenous) Cytomegalovirus Immune Globulin Intravenous (Human)
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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