Company 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.


California Department of Public Health (CDPH)
BabyBig (For Injection) (Intravenous) Botulism Immune Globulin Intravenous (Human)
NDA Applicant: California Department of Public Health (CDPH)      BLA No.: 125034  Prod. No.: 001 Rx (100MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityOct 23, 2010Orphan Designation: Treatment of infant botulism.
Approved Labeled Indication: Indicated for treatment of infant botulism caused by type A or type B Clostridium botulinum.

Celgene Corporation, a Bristol-Myers Squibb Company
Abecma (Injection) (Intravenous) idecabtagene vicleucel
NDA Applicant: Celgene Corporation, a Bristol-Myers Squibb Company      BLA No.: 125736  Prod. No.: 001 Rx (150 TO 540 X 10^6 CHIMERIC ANTIGEN RECEPTOR (CAR)-POSITIVE T CELLS IN ONE OR MORE INFUSION)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMar 26, 2028Orphan Designation: Treatment of multiple myeloma
Approved Labeled Indication: treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, 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 an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody

Celgene Corporation, a Bristol-Myers Squibb Company
Reblozyl (For Injection) (Subcutaneous) luspatercept-aamt
NDA Applicant: Celgene Corporation, a Bristol-Myers Squibb Company      BLA No.: 761136  Prod. No.: 001 Rx (25MG/VIAL); 002 Rx (75MG/VIAL)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityNov 8, 2026Orphan Designation: Treatment of B-thalassemia
Approved Labeled Indication: REBLOZYL is indicated for the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions.
Exclusivity Protected Indication: Indicated for the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions.
Exclusivity Type: Orphan Drug ExclusivityApr 3, 2027Orphan Designation: Treatment of myelodysplastic syndrome
Approved Labeled Indication: REBLOZYL is indicated for the treatment of anemia failing an erythropoiesis stimulating agent and requiring 2 or more red blood cell units over 8 weeks in adult patients with very low- to intermediate-risk myelodysplastic syndromes with ring sideroblasts (MDS-RS) or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T).
Exclusivity Protected Indication: For the treatment of anemia failing an erythropoiesis stimulating agent and requiring 2 or more red blood cell units over 8 weeks in adult patients with very low- to intermediate-risk myelodysplastic syndromes with ring sideroblasts (MDS-RS)

Chiesi USA, Inc.
Revcovi (Injection) (Intramuscular) elapegademase-lvlr
NDA Applicant: Chiesi USA, Inc.      BLA No.: 761092  Prod. No.: 001 Rx (2.4MG/1.5ML (1.6MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityOct 5, 2025Orphan Designation: Treatment of adenosine deaminase deficiency in patients with severe combined immunodeficiency.
Approved Labeled Indication: Treatment of Adenosine Deaminase-Severe Combined Immunodeficiency (ADA-SCID).
Exclusivity Protected Indication: treatment of adenosine deaminase severe combined immune deficiency (ADA-SCID) in pediatric and adult patients.

Clinigen, Inc.
Proleukin (For Injection) (Intravenous) aldesleukin
Drug Classes: Antineoplastics:Antineoplastics, Other == lymphocyte growth factor
NDA Applicant: Clinigen, Inc.      BLA No.: 103293  Prod. No.: 001 Rx (22MILLION INTERNATIONAL UNITS (1.3MG))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMay 5, 1999Orphan Designation: Treatment of metastatic renal cell carcinoma.
Approved Labeled Indication: Treatment of adults (>18 years old) with metastatic renal cell carcinoma.
Exclusivity Type: Orphan Drug ExclusivityJan 9, 2005Orphan Designation: Treatment of metastatic melanoma.
Approved Labeled Indication: Treatment of adults with metastatic melanoma.

Coherus BioSciences, Inc.
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 

CSL Behring AG
Hizentra (Injection) (Subcutaneous) Immune Globulin Subcutaneous (Human), 20% Liquid
Drug Classes: Immunological Agents:Immunoglobulins == human immunoglobulin G
NDA Applicant: CSL Behring AG      BLA No.: 125350  Prod. No.: 001 Rx (2G); 002 Rx (1G); 003 Rx (10G); 004 Rx (4G)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMar 15, 2025Orphan Designation: Treatment of chronic inflammatory demyelinating polyneuropathy (CIDP)
Approved Labeled Indication: Indicated for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy to prevent relapse of neuromuscular disability and impairment.
Exclusivity Protected Indication: Indicated for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy to prevent relapse of neuromuscular disability and impairment

CSL Behring GmbH
Berinert (For Injection) (Intravenous) C1 Esterase Inhibitor (Human)
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.

CSL Behring GmbH
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.

CSL Behring GmbH
Haegarda (For Injection) (Subcutaneous) C1 Esterase Inhibitor Subcutaneous (Human)
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.

CSL Behring GmbH
Humate-P (For Injection) (Intravenous) Antihemophilic Factor/von Willebrand Factor Complex (Human)
Drug Classes: Blood Products and Modifiers:Blood Component Deficiency/ Replacement == human antihemophilic factor
NDA Applicant: CSL Behring GmbH      BLA No.: 103960  Prod. No.: 001 Rx (1000IU); 002 Rx (250IU); 003 Rx (500IU)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityApr 1, 2006Orphan Designation: Treatment of patients with von Willebrand's disease
Approved Labeled Indication: (1) In adult patients for treatment and prevention of bleeding in hemophilia A (classic hemophilia) and (2) in adult and pediatric patients for treatment of spontaneous and trauma-induced bleeding episodes in severe von Willebrand disease, and in mild and moderate von Willebrand disease where use of desmopressin is known or suspected to be inadequate.

CSL Behring GmbH
Kcentra (For Injection) (Intravenous) Prothrombin Complex Concentrate (Human)
Drug Classes: blood coagulation factor
NDA Applicant: CSL Behring GmbH      BLA No.: 125421  Prod. No.: 001 Rx (500IU); 002 Rx (1000IU)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityApr 29, 2020Orphan Designation: Treatment of patients needing urgent reversal of Vitamin K antagonist therapy for treatment of major bleeding and/or surgical procedures
Approved Labeled Indication: Urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with acute major bleeding.
Exclusivity Protected Indication: Urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with acute major bleeding.
Exclusivity Type: Orphan Drug ExclusivityDec 13, 2020Orphan Designation: Treatment of patients needing urgent reversal of Vitamin K antagonist therapy for treatment of major bleeding and/or surgical procedures
Approved Labeled Indication: Urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with acute major bleeding or need for an urgent surgery/invasive procedure.
Exclusivity Protected Indication: Urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist therapy (VKA, e.g., warfarin) in adult patients with the need for urgent surgery/invasive procedure.

CSL Behring GmbH
Riastap (For Injection) (Intravenous) Fibrinogen Concentrate (Human)
Drug Classes: Blood Products and Modifiers:Blood Component Deficiency/ Replacement == human blood coagulation factor
NDA Applicant: CSL Behring GmbH      BLA No.: 125317  Prod. No.: 001 Rx (900-1300MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJan 16, 2016Orphan Designation: Treatment of fibrinogen deficient patients.
Approved Labeled Indication: Treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency (afibrinogenemia and hypofibrinogenemia)

CSL Behring Lengnau AG
Idelvion (For Injection) (Intravenous) Coagulation Factor IX (Recombinant), Albumin Fusion Protein
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.

CSL Behring LLC
Mononine (For Injection) (Intravenous) Coagulation Factor IX (Human)
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.



Last edited: 15 November 2022
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