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 | 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. |
ranibizumab (Injection) (Intravitreal) Lucentis
NDA Applicant: Genentech, Inc. BLA No.: 125156 Prod. No.: 001 Rx (10MG/ML (0.5MG/0.05ML)); 002 Rx (6MG/ML (0.3MG/0.05ML)); 003 Rx (10MG/ML (0.5MG/0.05ML)); 004 Rx (6MG/ML (0.3MG/0.05ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6716602 Metabolic rate shifts in fermentations expressing recombinant proteins Claim Types: Process Pat. Sub. Date(s): None | Nov 1, 2021 | |
| Pat. No. 6828121 Bacterial host strains Claim Types: Bacterial strain; Process Pat. Sub. Date(s): None | Jul 8, 2022 | |
| Pat. No. 6921659 Protease-deficient cells Claim Types: Bacterial strain; Process Pat. Sub. Date(s): None | Oct 17, 2023 | |
| Pat. No. 8383773 Protein product and method for reducing biomass-biomass interactions Claim Types: Product-by-process Pat. Sub. Date(s): None | Dec 13, 2023 | |
| 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. 9688775 System for antibody expression and assembly Claim Types: Process Pat. Sub. Date(s): None | Dec 31, 2022 | |
| Pat. No. 9765379 Harvest operations for recombinant proteins Claim Types: Process Pat. Sub. Date(s): None | Mar 10, 2034 | |
| 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. 10112994 Methods of producing two chain proteins in bacteria Claim Types: Process Pat. Sub. Date(s): None | Nov 5, 2035 | |
| Pat. No. 10421984 Methods for reducing norleucine misincorporation into proteins using a microorganism comprising a mutant metA allele Claim Types: Process Pat. Sub. Date(s): None | Sep 19, 2033 | |
| Pat. No. 10829732 Cell culture compositions with antioxidants and methods for polypeptide production Claim Types: Process Pat. Sub. Date(s): None | Mar 14, 2034 |
ranibizumab-eqrn (Injection) (Intravitreal) Cimerli
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 |
rasburicase (For Injection) (Intravenous) Elitek
NDA Applicant: Sanofi-Aventis U.S. LLC BLA No.: 103946 Prod. No.: 001 Rx (1.5MG); 002 Rx (7.5MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Jul 12, 2009 | Orphan Designation: Treatment of malignancy-associated or chemotherapy-induced hyperuricemia. Approved Labeled Indication: Initial management of plasma uric acid levels in pediatric patients with leukemia,lymphoma, and solid tumor malignancies who are receiving anti-cancer therapy expected to result in tumor lysis and subsequent elevation of plasma uric acid. |
ravulizumab-cwvz (Injection) (Intravenous; Subcutaneous) Ultomiris
NDA Applicant: Alexion Pharmaceuticals, Inc. BLA No.: 761108 Prod. No.: 001 Rx (300MG/30ML (10MG/ML)); 002 Rx (300MG/3ML (100MG/ML)); 003 Rx (1,100MG/11ML (100MG/ML)); 004 Rx (245MG/3.5ML (70MG/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Dec 21, 2025 | Orphan Designation: Treatment of paroxysmal nocturnal hemoglobinuria Approved Labeled Indication: ULTOMIRIS is indicated for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH). Exclusivity Protected Indication: ULTOMIRIS is indicated for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH). |
| Exclusivity Type: Orphan Drug Exclusivity | Jun 7, 2028 | Orphan Designation: Treatment of paroxysmal nocturnal hemoglobinuria Approved Labeled Indication: Treatment of adult and pediatric patients one month of age and older with paroxysmal nocturnal hemoglobinuria (PNH) Exclusivity Protected Indication: Treatment of pediatric patients one month of age and older with paroxysmal nocturnal hemoglobinuria (PNH) |
raxibacumab (Injection) (Intravenous) N/A
NDA Applicant: Emergent Manufacturing Operations Baltimore LLC BLA No.: 125349 Prod. No.: 001 Rx (1,700MG/34ML (50MG/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Dec 14, 2019 | 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. |
Respiratory Syncytial Virus Vaccine, Adjuvanted (For Injection) (Intramuscular) Arexvy
NDA Applicant: GlaxoSmithKline Biologicals BLA No.: 125775 Prod. No.: 001 Rx (120UG/.5ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Ref. Product Exclusivity | May 3, 2035 |
retifanlimab-dlwr (Injection) (Intravenous) Zynyz
NDA Applicant: Incyte Corporation BLA No.: 761334 Prod. No.: 001 Rx (500MG/20ML (25MG/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Mar 22, 2030 | Orphan Designation: Treatment of Merkel cell carcinoma Approved Labeled Indication: treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC) Exclusivity Protected Indication: treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC) |
Rho(D) Immune Globulin Intravenous (Human) (For Injection) (Intravenous; Intramuscular) Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized
NDA Applicant: Kamada Ltd. BLA No.: 103649 Prod. No.: 004 Rx (600IU); 005 Rx (1500IU); 007 Rx (5000IU); 013 Rx (600IU); 014 Rx (1500IU); 016 Rx (5000IU) BLA No.: 103649 Prod. No.: 001 Disc (600IU); 002 Disc (1500IU); 003 Disc (5,000IU); 006 Disc (2500IU); 008 Disc (15000IU); 009 Disc (3000IU); 010 Disc (600IU); 011 Disc (1500IU); 012 Disc (5,000IU); 015 Disc (2500IU); 017 Disc (15000IU); 018 Disc (3000IU)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Mar 24, 2002 | 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. |
rilonacept (For Injection) (Subcutaneous) Arcalyst
NDA Applicant: Kiniksa Pharmaceuticals (UK), Ltd. BLA No.: 125249 Prod. No.: 001 Rx (220MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Feb 27, 2015 | Orphan Designation: Treatment of CIAS1-Associated Periodic Syndromes Approved Labeled Indication: Treatment of Cryopyrin-Assisted Periodic Syndromes (CAPS) |
| Exclusivity Type: Orphan Drug Exclusivity | Mar 18, 2028 | Orphan Designation: Treatment of pericarditis Approved Labeled Indication: Treatment of recurrent pericarditis (RP) and reduction in risk of recurrence in adults and pediatric patients 12 years and older Exclusivity Protected Indication: Treatment of recurrent pericarditis (RP) and reduction in risk of recurrence in adults and pediatric patients 12 years and older |
rimabotulinumtoxinB (Injection) (Intramuscular, Intraglandular) Myobloc
NDA Applicant: Solstice NeuroSciences, LLC BLA No.: 103846 Prod. No.: 001 Rx (2,500UNITS/0.5ML); 002 Rx (5,000UNITS/ML); 003 Rx (10,000UNITS/2ML (5,000UNITS/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Dec 8, 2007 | Orphan Designation: Treatment of cervical dystonia. Approved Labeled Indication: Treatment of patients with cervical dystonia to reduce the severity of abnormal head position and neck pain associated with cervical dystonia. |
rituximab (Injection) (Intravenous) Rituxan
NDA Applicant: Genentech, Inc. BLA No.: 103705 Prod. No.: 001 Rx (100MG/10ML (10MG/ML)); 002 Rx (500MG/50ML (10MG/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Nov 26, 2004 | Orphan Designation: Treatment of non-Hodgkin's B-cell lymphoma Approved Labeled Indication: Treatment of patients with relapsed or refractory low-grade or follicular, CD20 positive, B-cell non-Hodgkin's lymphoma |
| Exclusivity Type: Orphan Drug Exclusivity | Feb 18, 2017 | Orphan Designation: Treatment of chronic lymphocytic leukemia Approved Labeled Indication: Treatment of patients previously untreated for CD20-positive chronic lymphocytic leukemia in combination wih fludarbine and cyclophosphamide |
| Exclusivity Type: Orphan Drug Exclusivity | Apr 19, 2018 | Orphan Designation: Treatment of patients with anti-neutrophil cytoplasmic antibody-associated vasculitis (Wegener's Granulomatosis, Microscopic Polyangiitis, and Churg-Strauss Syndrome) Approved Labeled Indication: For the use of Rituxan (rituximab) in combination with glucocorticoids for the treatment of patients with Wegener's Granulomatosis (WG) and Microscopic Polyangiitis (MPA). ) |
| Exclusivity Type: Orphan Drug Exclusivity | Sep 27, 2026 | Orphan Designation: Treatment of patients with anti-neutrophil cytoplasmic antibody-associated vasculitis (Wegener's Granulomatosis, Microscopic Polyangiitis, and Churg-Strauss Syndrome) Approved Labeled Indication: RITUXAN, in combination with glucocorticoids, is indicated for the treatment of adult and pediatric patients 2 years of age and older with Granulomatosis with Polyangiitis (GPA) (Wegener?s Granulomatosis) and Microscopic Polyangiitis (MPA) Exclusivity Protected Indication: indicated in combination with glucocorticoids, for the treatment of pediatric patients 2 years of age and older with Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA) |
| Exclusivity Type: Orphan Drug Exclusivity | Dec 2, 2028 | Orphan Designation: Treatment of non-Hodgkin's B-cell lymphoma Approved Labeled Indication: treatment of pediatric patients aged 6 months and older with previously untreated, advanced stage, CD20-positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), Burkitt-like lymphoma (BLL) or mature B-cell acute leukemia (B-AL) in combination with chemotherapy Exclusivity Protected Indication: treatment of pediatric patients aged 6 months and older with previously untreated, advanced stage, CD20-positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), Burkitt-like lymphoma (BLL) or mature B-cell acute leukemia (B-AL) |
rituximab (Injection) (Intravenous) Rituxan
NDA Applicant: IDEC Pharmaceuticals Corp. BLA No.: 103737 Prod. No.: 001 Disc (100MG/10ML (10MG/ML)); 002 Disc (500MG/50ML (10MG/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Nov 26, 2004 | Orphan Designation: Treatment of non-Hodgkin's B-cell lymphoma Approved Labeled Indication: Treatment of patients with relapsed or refractory low-grade or follicular, CD20 positive, B-cell non-Hodgkin's lymphoma |
| Exclusivity Type: Orphan Drug Exclusivity | Feb 18, 2017 | Orphan Designation: Treatment of chronic lymphocytic leukemia Approved Labeled Indication: Treatment of patients previously untreated for CD20-positive chronic lymphocytic leukemia in combination wih fludarbine and cyclophosphamide |
| Exclusivity Type: Orphan Drug Exclusivity | Apr 19, 2018 | Orphan Designation: Treatment of patients with anti-neutrophil cytoplasmic antibody-associated vasculitis (Wegener's Granulomatosis, Microscopic Polyangiitis, and Churg-Strauss Syndrome) Approved Labeled Indication: For the use of Rituxan (rituximab) in combination with glucocorticoids for the treatment of patients with Wegener's Granulomatosis (WG) and Microscopic Polyangiitis (MPA). ) |
| Exclusivity Type: Orphan Drug Exclusivity | Sep 27, 2026 | Orphan Designation: Treatment of patients with anti-neutrophil cytoplasmic antibody-associated vasculitis (Wegener's Granulomatosis, Microscopic Polyangiitis, and Churg-Strauss Syndrome) Approved Labeled Indication: RITUXAN, in combination with glucocorticoids, is indicated for the treatment of adult and pediatric patients 2 years of age and older with Granulomatosis with Polyangiitis (GPA) (Wegener?s Granulomatosis) and Microscopic Polyangiitis (MPA) Exclusivity Protected Indication: indicated in combination with glucocorticoids, for the treatment of pediatric patients 2 years of age and older with Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA) |
| Exclusivity Type: Orphan Drug Exclusivity | Dec 2, 2028 | Orphan Designation: Treatment of non-Hodgkin's B-cell lymphoma Approved Labeled Indication: treatment of pediatric patients aged 6 months and older with previously untreated, advanced stage, CD20-positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), Burkitt-like lymphoma (BLL) or mature B-cell acute leukemia (B-AL) in combination with chemotherapy Exclusivity Protected Indication: treatment of pediatric patients aged 6 months and older with previously untreated, advanced stage, CD20-positive diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma (BL), Burkitt-like lymphoma (BLL) or mature B-cell acute leukemia (B-AL) |
rituximab and hyaluronidase human (Injection) (Subcutaneous) Rituxan Hycela
NDA Applicant: Genentech, Inc. BLA No.: 761064 Prod. No.: 001 Rx (1,400MG/11.7ML; 23,400UNITS/11.7ML (120MG/2,000UNITS/ML)); 002 Rx (1,600MG/13.4ML; 26,800UNITS/13.4ML (120MG/2,000UNITS/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Jun 22, 2024 | Orphan Designation: Treatment of diffuse large B-cell lymphoma Approved Labeled Indication: Treatment of adult patients with previously untreated diffuse large B-cell lymphoma in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or other anthracycline-based chemotherapy regimens Exclusivity Protected Indication: Treatment of adult patients with previously untreated diffuse large B-cell lymphoma in combination with cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) or other anthracycline-based chemotherapy regimens |
| Exclusivity Type: Orphan Drug Exclusivity | Jun 22, 2024 | Orphan Designation: Treatment of chronic lymphocytic leukemia (CLL) Approved Labeled Indication: Treatment of adult patients with previously untreated and previously treated CLL in combination with fludarabine and cyclophosphamide Exclusivity Protected Indication: Treatment of adult patients with previously untreated and previously treated CLL in combination with fludarabine and cyclophosphamide |
| Exclusivity Type: Orphan Drug Exclusivity | Jun 22, 2024 | Orphan Designation: Treatment of follicular lymphoma Approved Labeled Indication: Treatment of adult patients with relapsed or refractory, follicular lymphoma as a single agent; previously untreated follicular lymphoma in combination with first line chemotherapy and, in patients achieving a complete or partial response to rituximab in combination with chemotherapy, as single-agent maintenance therapy; and non-progressing (including stable disease), follicular lymphoma as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy. Exclusivity Protected Indication: Treatment of adult patients with relapsed or refractory, follicular lymphoma as a single agent; previously untreated follicular lymphoma in combination with first line chemotherapy and, in patients achieving a complete or partial response to rituximab in combination with chemotherapy, as single-agent maintenance therap; and non-progressing (including stable disease), follicular lymphoma as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy. |
romiplostim (For Injection) (Subcutaneous) Nplate
NDA Applicant: Amgen Inc. BLA No.: 125268 Prod. No.: 001 Rx (250MCG); 002 Rx (500MCG); 003 Rx (125MCG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Aug 22, 2015 | Orphan Designation: Treatment of immune thrombocytopenic purpura Approved Labeled Indication: Treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy |
| Exclusivity Type: Orphan Drug Exclusivity | Dec 14, 2025 | Orphan Designation: Treatment of immune thrombocytopenic purpura Approved Labeled Indication: Nplate is indicated for the treatment of thrombocytopenia in pediatric patients 1 year of age and older with ITP for at least 6 months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Exclusivity Protected Indication: Nplate is indicated for the treatment of pediatric patients 1 year of age and older with immune thrombocytopenia (ITP) for at least 6 months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. |
| Exclusivity Type: Orphan Drug Exclusivity | Oct 17, 2026 | Orphan Designation: Treatment of immune thrombocytopenic purpura Approved Labeled Indication: Nplate is indicated for the treatment of thrombocytopenia in adult patients with immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy Exclusivity Protected Indication: For the treatment of thrombocytopenia in adult patients with non-chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. |
| Exclusivity Type: Orphan Drug Exclusivity | Jan 28, 2028 | Orphan Designation: Treatment of patients acutely exposed to myelosuppressive doses of radiation following radiological/nuclear incident Approved Labeled Indication: to increase survival in adults and pediatric patients (including term neonates) acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome [HS-ARS]) Exclusivity Protected Indication: to increase survival in adults and pediatric patients (including term neonates) acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome [HS-ARS]) |
ropeginterferon alfa-2b-njft (Injection) (Subcutaneous) Besremi
NDA Applicant: PharmaEssentia Corporation BLA No.: 761166 Prod. No.: 001 Rx (500MCG/ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Nov 12, 2028 | Orphan Designation: Treatment of polycythemia vera Approved Labeled Indication: Treatment of adults with polycythemia vera Exclusivity Protected Indication: Treatment of adults with polycythemia vera |
rozanolixizumab-noli (Injection) (Subcutaneous) Rystiggo
NDA Applicant: UCB, Inc. BLA No.: 761286 Prod. No.: 001 Rx (280MG/2ML (140MG/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Jun 26, 2030 | Orphan Designation: Treatment of myasthenia gravis Approved Labeled Indication: treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive Exclusivity Protected Indication: treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive |