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 | May 12, 2005 | Orphan Designation: Prophylaxis of solid organ rejection. Approved Labeled Indication: Prophylaxis of acute organ rejection in patients receiving renal transplantation when used as part of an immunosuppressive regimen that includes cyclosporine and corticosteroids. |
belantamab mafodotin-blmf (For Injection) (Intravenous) Blenrep
NDA Applicant: GlaxoSmithKline Intellectual Property Development Ltd. England BLA No.: 761158 Prod. No.: 001 Disc (100MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Aug 5, 2027 | 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. |
belatacept (For Injection) (Intravenous) Nulojix
NDA Applicant: Bristol-Myers Squibb Company BLA No.: 125288 Prod. No.: 001 Rx (250MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Jun 15, 2018 | Orphan Designation: Prophylaxis of organ rejection in renal allograft recipients Approved Labeled Indication: Prophylaxis of organ rejection in adult patients receiving kidney transplants |
beractant (Suspension) (Intratracheal) Survanta
NDA Applicant: AbbVie Inc. BLA No.: 020032 Prod. No.: 001 Rx (100MG/4ML (25MG/ML)); 002 Rx (200MG/8ML (25MG/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Jul 2, 1998 | 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. |
beremagene geperpavec-svdt (Gel) (Topical) VYJUVEK
NDA Applicant: Krystal Biotech, Inc. BLA No.: 125774 Prod. No.: 001 Rx (5.0x10^9 PFU/mL)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | May 19, 2030 | Orphan Designation: Treatment of dystrophic epidermolysis bullosa Approved Labeled Indication: treatment of wounds in patients 6 months of age and older with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene Exclusivity Protected Indication: treatment of wounds in patients 6 months of age and older with dystrophic epidermolysis bullosa (DEB) with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene |
betibeglogene autotemcel (For Injection) (Intravenous) Zynteglo
NDA Applicant: Bluebird Bio Inc. BLA No.: 125717 Prod. No.: 001 Rx (1.7-20 X 10^6CELL/ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Aug 17, 2029 | Orphan Designation: Treatment of B-thalassemia major and intermedia Approved Labeled Indication: Treatment of adult and pediatric patients with beta-thalassemia who require regular red blood cell (RBC) transfusions Exclusivity Protected Indication: Treatment of adult and pediatric patients with beta-thalassemia who require regular red blood cell (RBC) transfusions |
| Exclusivity Type: Ref. Product Exclusivity | Aug 17, 2034 |
bevacizumab (Injection) (Intravenous) Avastin
NDA Applicant: Genentech, Inc. BLA No.: 125085 Prod. No.: 001 Rx (100MG/4ML (25MG/ML)); 002 Rx (400MG/16ML (25MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7485704 Reducing protein A leaching during protein A affinity chromatography Claim Types: Process Pat. Sub. Date(s): None | Mar 8, 2025 | |
| Pat. No. 8460895 Method for producing recombinant proteins with a constant content of pCO.sub.2 in the medium Claim Types: Process Pat. Sub. Date(s): None | Mar 11, 2029 | |
| Pat. No. 8512983 Production of proteins in glutamine-free cell culture media Claim Types: Process; Cell culture medium Pat. Sub. Date(s): None | Jan 4, 2031 | |
| Pat. No. 8574869 Prevention of disulfide bond reduction during recombinant production of polypeptides Claim Types: Process Pat. Sub. Date(s): None | Jul 8, 2028 | |
| Pat. No. 9441035 Cell culture media and methods of antibody production Claim Types: Process Pat. Sub. Date(s): None | Apr 23, 2034 | |
| Pat. No. 9487809 Decreasing lactate level and increasing polypeptide production by downregulating the expression of lactate dehydrogenase and pyruvate dehydrogenase kinase Claim Types: Process Pat. Sub. Date(s): None | Jan 14, 2032 | |
| Pat. No. 9714293 Production of proteins in glutamine-free cell culture media Claim Types: Process Pat. Sub. Date(s): None | Aug 6, 2030 | |
| Pat. No. 9795672 Treatment with anti-VEGF antibodies Claim Types: Method of use Pat. Sub. Date(s): None | May 28, 2024 | |
| Pat. No. 10011856 Decreasing lactate level and increasing polypeptide production by downregulating the expression of lactate dehydrogenase and pyruvate dehydrogenase kinase Claim Types: Cell culture Pat. Sub. Date(s): None | May 26, 2031 | |
| Pat. No. 10017732 Cell culture compositions with antioxidants and methods for polypeptide production Claim Types: Process Pat. Sub. Date(s): None | Mar 14, 2034 | |
| Pat. No. 10208355 Method of treatment for glioblastoma by administering a VEGF antagonist Claim Types: Method of use Pat. Sub. Date(s): None | Jul 14, 2035 | |
| Pat. No. 10274466 Elucidation of ion exchange chromatography input optimization Claim Types: Analytical procedure Pat. Sub. Date(s): None | Jul 11, 2035 | |
| Pat. No. 10336983 Method for increasing the specific production rate of eukaryotic cells Claim Types: Process Pat. Sub. Date(s): None | Jul 31, 2035 | |
| Pat. No. 10513697 CO.sub.2 profile cultivation Claim Types: Process Pat. Sub. Date(s): None | Sep 17, 2032 | |
| Pat. No. 10662237 Method to improve virus filtration capacity Claim Types: Process Pat. Sub. Date(s): None | May 26, 2031 | |
| Pat. No. 10676710 Cell culture compositions with antioxidants and methods for polypeptide production Claim Types: Process Pat. Sub. Date(s): None | Mar 14, 2034 | |
| Pat. No. 10704071 Decreasing lactate level and increasing polypeptide production by down regulating the expression of lactate dehydrogenase and pyruvate dehydrogenase kinase Claim Types: Vector Pat. Sub. Date(s): None | Aug 18, 2031 | |
| Pat. No. 10829732 Cell culture compositions with antioxidants and methods for polypeptide production Claim Types: Process Pat. Sub. Date(s): None | Mar 14, 2034 | |
| Pat. No. 10906934 Protein purification methods Claim Types: Process Pat. Sub. Date(s): None | Oct 12, 2033 | |
| Pat. No. 10906986 Prevention of disulfide bond reduction during recombinant production of polypeptides Claim Types: Process Pat. Sub. Date(s): None | Jul 8, 2028 | |
| Pat. No. 10982003 Production of proteins in glutamine-free cell culture media Claim Types: Process Pat. Sub. Date(s): None | Aug 6, 2030 | |
| Pat. No. 11078294 Prevention of disulfide bond reduction during recombinant production of polypeptides Claim Types: Process Pat. Sub. Date(s): None | Jul 8, 2028 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Type: Orphan Drug Exclusivity | May 5, 2016 | Orphan Designation: Treatment of malignant glioma Approved Labeled Indication: Treatment of glioblastoma with progressive disease following prior therapy |
| Exclusivity Type: Orphan Drug Exclusivity | Jul 31, 2016 | Orphan Designation: Treatment of renal cell carcinoma Approved Labeled Indication: Treatment of renal cell carcinoma in combination with interferon alfa |
| Exclusivity Type: Orphan Drug Exclusivity | Nov 14, 2021 | Orphan Designation: Therapeutic treatment of patients with ovarian cancer Approved Labeled Indication: In combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for treatment of patients with platinum-resistant, recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than 2 prior chemotherapy regimens Exclusivity Protected Indication: In combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for treatment of patients with platinum-resistant, recurrent epithelial ovarian cancer who have received no more than 2 prior chemotherapy regimens. |
| Exclusivity Type: Orphan Drug Exclusivity | Nov 14, 2021 | Orphan Designation: Treatment of primary peritoneal carcinoma. Approved Labeled Indication: In combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for treatment of patients with platinum-resistant, recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than 2 prior chemotherapy regimens Exclusivity Protected Indication: In combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for treatment of patients with platinum-resistant, recurrent primary peritoneal cancer who received no more than 2 prior chemotherapy regimens |
| Exclusivity Type: Orphan Drug Exclusivity | Nov 14, 2021 | Orphan Designation: Treatment of fallopian tube carcinoma Approved Labeled Indication: In combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for treatment of patients with platinum-resistant, recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received no more than 2 prior chemotherapy regimens. Exclusivity Protected Indication: In combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for treatment of patients with platinum-resistant, recurrent fallopian tube cancer who have received no more than 2 prior chemotherapy regimens. |
| Exclusivity Type: Orphan Drug Exclusivity | Dec 6, 2023 | Orphan Designation: Therapeutic treatment of patients with ovarian cancer Approved Labeled Indication: Avastin in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan is indicated for the treatment of patients with platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who received no more than 2 prior chemotherapy regimens. Avastin, either in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine, followed by Avastin as a single agent, is indicated for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. Exclusivity Protected Indication: Either in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine, followed by Avastin as a single agent, is indicated for the treatment of patients with platinum-sensitive recurrent epithelial ovarian cancer. |
| Exclusivity Type: Orphan Drug Exclusivity | Dec 6, 2023 | Orphan Designation: Treatment of primary peritoneal carcinoma. Approved Labeled Indication: Avastin in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan is indicated for the treatment of patients with platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who received no more than 2 prior chemotherapy regimens. Avastin, either in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine, followed by Avastin as a single agent, is indicated for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. Exclusivity Protected Indication: Either in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine, followed by Avastin as a single agent, is indicated for the treatment of patients with platinum-sensitive recurrent primary peritoneal cancer. |
| Exclusivity Type: Orphan Drug Exclusivity | Dec 6, 2023 | Orphan Designation: Treatment of fallopian tube carcinoma Approved Labeled Indication: Avastin in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan is indicated for the treatment of patients with platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who received no more than 2 prior chemotherapy regimens. Avastin, either in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine, followed by Avastin as a single agent, is indicated for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. Exclusivity Protected Indication: Either in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine, followed by Avastin as a single agent, is indicated for the treatment of patients with platinum-sensitive recurrent fallopian tube cancer. |
| Exclusivity Type: Orphan Drug Exclusivity | Jun 13, 2025 | Orphan Designation: Therapeutic treatment of patients with ovarian cancer Approved Labeled Indication: Avastin, in combination with carboplatin and paclitaxel, followed by Avastin as a single agent, is indicated for the treatment of patients with stage III or IV epithelial ovarian, fallopian tube, orprimary peritoneal cancer following initial surgical resection. Avastin, in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan, is indicated for the treatment of patients with platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who received no more than 2 prior chemotherapy regimens. Avastin, in combination with carboplatin and paclitaxel, or with carboplatin and gemcitabine, followed by Avastin as a single agent, is indicated for the treatment of patients with platinum-sensitiverecurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. Exclusivity Protected Indication: In combination with carboplatin and paclitaxel, followed by Avastin as a single agent, is indicated for the treatment of patients with stage III or IV epithelial ovarian cancer following initial surgical resection. |
| Exclusivity Type: Orphan Drug Exclusivity | Jun 13, 2025 | Orphan Designation: Treatment of fallopian tube carcinoma Approved Labeled Indication: Avastin, in combination with carboplatin and paclitaxel, followed by Avastin as a single agent, is indicated for the treatment of patients with stage III or IV epithelial ovarian, fallopian tube, orprimary peritoneal cancer following initial surgical resection. Avastin, in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan, is indicated for the treatment of patients with platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who received no more than 2 prior chemotherapy regimens. Avastin, in combination with carboplatin and paclitaxel, or with carboplatin and gemcitabine, followed by Avastin as a single agent, is indicated for the treatment of patients with platinum-sensitiverecurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. Exclusivity Protected Indication: In combination with carboplatin and paclitaxel, followed by Avastin as a single agent, is indicated for the treatment of patients with stage III or IV fallopian tube cancer following initial surgical resection. |
| Exclusivity Type: Orphan Drug Exclusivity | Jun 13, 2025 | Orphan Designation: Treatment of primary peritoneal carcinoma. Approved Labeled Indication: Avastin, in combination with carboplatin and paclitaxel, followed by Avastin as a single agent, is indicated for the treatment of patients with stage III or IV epithelial ovarian, fallopian tube, orprimary peritoneal cancer following initial surgical resection. Avastin, in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan, is indicated for the treatment of patients with platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who received no more than 2 prior chemotherapy regimens. Avastin, in combination with carboplatin and paclitaxel, or with carboplatin and gemcitabine, followed by Avastin as a single agent, is indicated for the treatment of patients with platinum-sensitiverecurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. Exclusivity Protected Indication: In combination with carboplatin and paclitaxel, followed by Avastin as a single agent, is indicated for the treatment of patients with stage III or IV primary peritoneal cancer following initial surgical resection. |
| Exclusivity Type: Orphan Drug Exclusivity | May 29, 2027 | 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. |
blinatumomab (For Injection) (Intravenous) Blincyto
NDA Applicant: Amgen Inc. BLA No.: 125557 Prod. No.: 001 Rx (35MCG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Dec 3, 2021 | Orphan Designation: Treatment of acute lymphocytic leukemia Approved Labeled Indication: Treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). Exclusivity Protected Indication: Treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). |
| Exclusivity Type: Orphan Drug Exclusivity | Aug 30, 2023 | Orphan Designation: Treatment of acute lymphocytic leukemia Approved Labeled Indication: treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) Exclusivity Protected Indication: treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) in patients weighing less than 45 kg |
| Exclusivity Type: Orphan Drug Exclusivity | Jul 11, 2024 | Orphan Designation: Treatment of acute lymphocytic leukemia Approved Labeled Indication: treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) in adults and children Exclusivity Protected Indication: treatment of Philadelphia chromosome-positive relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) in adults and children |
| Exclusivity Type: Orphan Drug Exclusivity | Mar 29, 2025 | Orphan Designation: Treatment of acute lymphocytic leukemia Approved Labeled Indication: BLINCYTO is indicated for the treatment of B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1% in adults and children. Exclusivity Protected Indication: For the treatment of B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1% in adults and children |
Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) - (Equine) (Solution) (Intravenous) Bat
NDA Applicant: Emergent BioSolutions Canada Inc. BLA No.: 125462 Prod. No.: 001 Rx (>4500U)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Mar 22, 2020 | Orphan Designation: Treatment of botulism. Approved Labeled Indication: Treatment of symptomatic botulism following documented or suspected exposure to botulinum neurotoxin (BoNT) serotypes A, B, C, D, E, F or G in adults and pediatric patients. Exclusivity Protected Indication: Treatment of symptomatic botulism following documented or suspected exposure to botulinum neurotoxin serotypes A, B, C, D, E, F, or G in adults and pediatric patients |
Botulism Immune Globulin Intravenous (Human) (For Injection) (Intravenous) BabyBig
NDA Applicant: California Department of Public Health (CDPH) BLA No.: 125034 Prod. No.: 001 Rx (100MG)
| 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. |
brentuximab vedotin (For Injection) (Intravenous) Adcetris
NDA Applicant: Seagen Inc. BLA No.: 125388 Prod. No.: 001 Rx (50MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 11505593 Anti-VEGF protein compositions and methods for producing the same Claim Types: Formulation; Drug in a container Pat. Sub. Date(s): None | Aug 18, 2040 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Type: Orphan Drug Exclusivity | Aug 19, 2018 | Orphan Designation: Treatment of peripheral T-cell lymphoma, including anaplastic large cell lymphoma, peripheral T-cell lymphoma not otherwise specified, angioimmunoblastic T-cell lymphoma, adult T-cell leukemia/lymphoma, enteropathy-associated T-cell lymphoma, and extranod Approved Labeled Indication: The treatment of patients with systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen |
| Exclusivity Type: Orphan Drug Exclusivity | Aug 19, 2018 | Orphan Designation: Treatment of Hodgkin's lymphoma Approved Labeled Indication: The treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant (ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates |
| Exclusivity Type: Orphan Drug Exclusivity | Aug 17, 2022 | Orphan Designation: Treatment of Hodgkin's lymphoma Approved Labeled Indication: Treatment of patients with classical Hodgkin lymphoma at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation. Exclusivity Protected Indication: Treatment of patients with classical Hodgkin lymphoma at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation. |
| Exclusivity Type: Orphan Drug Exclusivity | Nov 9, 2024 | Orphan Designation: Treatment of mycosis fungoides Approved Labeled Indication: Treatment for adult patients with CD30-expressing mycosis fungoides who have received prior systemic therapy Exclusivity Protected Indication: Treatment for adult patients with CD30-expressing mycosis fungoides who have received prior systemic therapy |
| Exclusivity Type: Orphan Drug Exclusivity | Nov 9, 2024 | Orphan Designation: Treatment of primary cutaneous CD30-positive T-cell lymphoproliferative disorders Approved Labeled Indication: For adult patients with primary cutaneous anaplastic large cell lymphoma who have received prior systemic therapy Exclusivity Protected Indication: For adult patients with primary cutaneous anaplastic large cell lymphoma who have received prior systemic therapy |
| Exclusivity Type: Orphan Drug Exclusivity | Mar 20, 2025 | Orphan Designation: Treatment of Hodgkin's lymphoma Approved Labeled Indication: ADCETRIS is indicated for the treatment of adult patients with previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with chemotherapy. Exclusivity Protected Indication: ADCETRIS is indicated for the treatment of adult patients with previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with chemotherapy. |
| Exclusivity Type: Orphan Drug Exclusivity | Nov 16, 2025 | Orphan Designation: Treatment of peripheral T-cell lymphoma, including anaplastic large cell lymphoma, peripheral T-cell lymphoma not otherwise specified, angioimmunoblastic T-cell lymphoma, adult T-cell leukemia/lymphoma, enteropathy-associated T-cell lymphoma, and extranod Approved Labeled Indication: ADCETRIS is indicated for the treatment of adult patients with previously untreated sALCL or other CD30-expressing PTCL, including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone Exclusivity Protected Indication: ADCETRIS is indicated for the treatment of adult patients with previously untreated sALCL or other CD30-expressing PTCL, including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone |
| Exclusivity Type: Orphan Drug Exclusivity | Nov 10, 2029 | Orphan Designation: Treatment of Hodgkin's lymphoma Approved Labeled Indication: treatment of pediatric patients 2 years and older with previously untreated high risk classical Hodgkin lymphoma (cHL) in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide Exclusivity Protected Indication: treatment of pediatric patients 2 years and older with previously untreated high risk classical Hodgkin lymphoma (cHL) |
Brexucabtagene Autoleucel (For Injection) (Intravenous) Tecartus
NDA Applicant: Kite Pharma Inc. BLA No.: 125703 Prod. No.: 001 Rx (2_10^6 CAR-positive viable T cells per kg body weight)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Jul 24, 2027 | Orphan Designation: Treatment of mantle cell lymphoma. Approved Labeled Indication: TECARTUS is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) Exclusivity Protected Indication: TECARTUS is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) |
| Exclusivity Type: Orphan Drug Exclusivity | Oct 1, 2028 | Orphan Designation: Treatment of acute lymphoblastic leukemia (ALL) Approved Labeled Indication: Treatment of adult patients with relapsed or refractory B-cell precursor acute lymphomblastic leukemia (ALL) Exclusivity Protected Indication: Treatment of adult patients with relapsed or refractory B-cell precursor acute lymphomblastic leukemia (ALL) |
burosumab-twza (Injection) (Subcutaneous) Crysvita
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 |