Generic names starting with "R"

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.


ramucirumab (Injection) (Intravenous) Cyramza
Drug Classes: Antineoplastics:Monoclonal Antibody/Antibody-Drug Conjugate == human vascular endothelial growth factor receptor 2 (VEGFR2) antagonist
NDA Applicant: Eli Lilly and Company      BLA No.: 125477  Prod. No.: 001 Rx (100MG/10ML (10MG/ML)); 002 Rx (500MG/50ML (10MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityApr 21, 2021Orphan 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 ExclusivityMay 10, 2026Orphan 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
Drug Classes: Ophthalmic Agents:Ophthalmic Agents, Other
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))
PatentsExpirationPatented Use
Pat. No. 6716602 Metabolic rate shifts in fermentations expressing recombinant proteins
Claim Types: Process
Pat. Sub. Date(s): None
Oct 31, 2021 
Pat. No. 6828121 Bacterial host strains
Claim Types: Bacterial strain; Process
Pat. Sub. Date(s): None
Jul 7, 2022 
Pat. No. 6921659 Protease-deficient cells
Claim Types: Bacterial strain; Process
Pat. Sub. Date(s): None
Oct 16, 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 7, 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 9, 2034 
Pat. No. 10017732 Cell culture compositions with antioxidants and methods for polypeptide production
Claim Types: Process
Pat. Sub. Date(s): None
Mar 13, 2034 
Pat. No. 10112994 Methods of producing two chain proteins in bacteria
Claim Types: Process
Pat. Sub. Date(s): None
Nov 4, 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 18, 2033 
Pat. No. 10829732 Cell culture compositions with antioxidants and methods for polypeptide production
Claim Types: Process
Pat. Sub. Date(s): None
Mar 13, 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))
ExclusivityExpirationExclusivity Description
Exclusivity Type: 1st Interchangeable ExclusivityDate TBD 

rasburicase (For Injection) (Intravenous) Elitek
Drug Classes: Antineoplastics:Treatment Adjuncts
NDA Applicant: Sanofi-Aventis U.S. LLC      BLA No.: 103946  Prod. No.: 001 Rx (1.5MG); 002 Rx (7.5MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJul 12, 2009Orphan 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))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityDec 21, 2025Orphan 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 ExclusivityJun 7, 2028Orphan 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)
Drug Classes: monoclonal antibody directed against the protective antigen of Bacillus anthracis
NDA Applicant: Emergent Manufacturing Operations Baltimore LLC      BLA No.: 125349  Prod. No.: 001 Rx (1,700MG/34ML (50MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityDec 14, 2019Orphan 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.

Rho(D) Immune Globulin Intravenous (Human) (For Injection) (Intravenous; Intramuscular) Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized
Drug Classes: Immunological Agents:Immunoglobulins
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)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMar 24, 2002Orphan 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
Drug Classes: Immunological Agents:Immunological Agents, Other
NDA Applicant: Kiniksa Pharmaceuticals (UK), Ltd.      BLA No.: 125249  Prod. No.: 001 Rx (220MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityFeb 27, 2015Orphan Designation: Treatment of CIAS1-Associated Periodic Syndromes
Approved Labeled Indication: Treatment of Cryopyrin-Assisted Periodic Syndromes (CAPS)
Exclusivity Type: Orphan Drug ExclusivityMar 18, 2028Orphan 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
Drug Classes: acetylcholine release inhibitor
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))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityDec 8, 2007Orphan 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
Drug Classes: Antineoplastics:Monoclonal Antibody/Antibody-Drug Conjugate == Immunological Agents:Immunosuppressants == CD20-directed cytolytic antibody
NDA Applicant: Genentech, Inc.      BLA No.: 103705  Prod. No.: 001 Rx (100MG/10ML (10MG/ML)); 002 Rx (500MG/50ML (10MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityNov 26, 2004Orphan 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 ExclusivityFeb 18, 2017Orphan 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 ExclusivityApr 19, 2018Orphan 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 ExclusivitySep 27, 2026Orphan 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)

rituximab (Injection) (Intravenous) Rituxan
Drug Classes: Antineoplastics:Monoclonal Antibody/Antibody-Drug Conjugate == Immunological Agents:Immunosuppressants == CD20-directed cytolytic antibody
NDA Applicant: IDEC Pharmaceuticals Corp.      BLA No.: 103737  Prod. No.: 001 Disc (100MG/10ML (10MG/ML)); 002 Disc (500MG/50ML (10MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityNov 26, 2004Orphan 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 ExclusivityFeb 18, 2017Orphan 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 ExclusivityApr 19, 2018Orphan 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 ExclusivitySep 27, 2026Orphan 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)

rituximab and hyaluronidase human (Injection) (Subcutaneous) Rituxan Hycela
Drug Classes: Antineoplastics:Monoclonal Antibody/Antibody-Drug Conjugate == Immunological Agents:Immunosuppressants == CD20-directed cytolytic antibody
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))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJun 22, 2024Orphan 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 ExclusivityJun 22, 2024Orphan 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 ExclusivityJun 22, 2024Orphan 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
Drug Classes: Blood Products and Modifiers:Blood Products and Modifiers, Other
NDA Applicant: Amgen, Inc.      BLA No.: 125268  Prod. No.: 001 Rx (250MCG); 002 Rx (500MCG); 003 Rx (125MCG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityAug 22, 2015Orphan 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 ExclusivityDec 14, 2025Orphan 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 ExclusivityOct 17, 2026Orphan 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 ExclusivityJan 28, 2028Orphan 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
Drug Classes: interferon alfa-2b
NDA Applicant: PharmaEssentia Corporation      BLA No.: 761166  Prod. No.: 001 Rx (500MCG/ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityNov 12, 2028Orphan Designation: Treatment of polycythemia vera
Approved Labeled Indication: Treatment of adults with polycythemia vera
Exclusivity Protected Indication: Treatment of adults with polycythemia vera



Last edited: 15 November 2022
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