Patents whose numbers are in italics have been extended under 35 USC 156. All expiration dates include applicable Sec. 156 and pediatric (PED) extensions.
| 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. |
Campath; Lemtrada (Injection) (Intravenous) alemtuzumab
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))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | May 7, 2008 | Orphan 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. |
Carvykti (For Injection) (Intravenous) ciltacabtagene autoleucel
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 |
Ceprotin (For Injection) (Intravenous) Protein C Concentrate (Human)
NDA Applicant: Takeda Pharmaceuticals U.S.A., Inc. BLA No.: 125234 Prod. No.: 001 Rx (500IU); 002 Rx (1000IU)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Mar 30, 2014 | Orphan 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
NDA Applicant: Genzyme Corporation BLA No.: 020367 Prod. No.: 002 Rx (400UNITS/VIAL) BLA No.: 020367 Prod. No.: 001 Disc (200UNITS/VIAL)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | May 23, 2001 | Orphan 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))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: 1st Interchangeable Exclusivity | Oct 3, 2023 |
Cinryze (For Injection) (Intravenous) C1 Esterase Inhibitor (Human)
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). |
Coagadex (For Injection) (Intravenous) Coagulation Factor X (Human)
NDA Applicant: Bio Products Laboratory BLA No.: 125506 Prod. No.: 001 Rx (500IU); 002 Rx (250IU)
| 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 |
Corifact (For Injection) (Intravenous) Factor XIII Concentrate (Human)
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. |
Crofab (For Injection) (Intravenous) Crotalidae Polyvalent Immune Fab (Ovine)
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 |
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)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Apr 17, 2025 | Orphan 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 Exclusivity | Sep 27, 2026 | Orphan 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 Exclusivity | Jun 18, 2027 | Orphan 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); 004 Rx (40MG/0.8ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: 1st Interchangeable Exclusivity | Date TBD |
Cyramza (Injection) (Intravenous) ramucirumab
NDA Applicant: Eli Lilly and Company BLA No.: 125477 Prod. No.: 001 Rx (100MG/10ML (10MG/ML)); 002 Rx (500MG/50ML (10MG/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Apr 21, 2021 | Orphan 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 Exclusivity | May 10, 2026 | Orphan 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)
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. |