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 | Oct 23, 2010 | Orphan 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)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Mar 26, 2028 | Orphan 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)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Nov 8, 2026 | Orphan 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 Exclusivity | Apr 3, 2027 | Orphan 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))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Oct 5, 2025 | Orphan 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))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | May 5, 1999 | Orphan 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 Exclusivity | Jan 9, 2005 | Orphan 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))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: 1st Interchangeable Exclusivity | Date 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)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Mar 15, 2025 | Orphan 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)
| 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. |
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)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Feb 17, 2018 | Orphan Designation: Treatment of congenital factor XIII deficiency Approved Labeled Indication: For the routine prophylactic treatment of congenital factor XIII deficiency |
| Exclusivity Type: Orphan Drug Exclusivity | Jan 24, 2020 | Orphan 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)
| 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. |
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)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Apr 1, 2006 | Orphan 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)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Apr 29, 2020 | Orphan 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 Exclusivity | Dec 13, 2020 | Orphan 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)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Jan 16, 2016 | Orphan 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)
| 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. |
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)
| 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. |