Tradenames starting with "R"

Patents whose numbers are in italics have been extended under 35 USC 156. All expiration dates include applicable Sec. 156 and pediatric (PED) extensions.

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)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityNov 8, 2026Orphan 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 ExclusivityApr 3, 2027Orphan 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)

Rebyota (Suspension) (Rectal) Fecal Microbiota Transplantation, Frozen Preparation
NDA Applicant: Ferring Pharmaceuticals Inc.      BLA No.: 125739  Prod. No.: 001 Rx (BETWEEN 1X10^8 AND 5X10^10CFU)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityNov 30, 2029Orphan Designation: Prevention of recurrent Clostridium difficile infection (CDI) in individuals with recurrent Clostridium difficile infection
Approved Labeled Indication: prevention of recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older following antibiotic treatment for recurrent CDI
Exclusivity Protected Indication: prevention of recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older following antibiotic treatment for recurrent CDI
Exclusivity Type: Ref. Product ExclusivityNov 30, 2034 

Remicade (For Injection) (Intravenous) infliximab
NDA Applicant: Janssen Biotech, Inc.      BLA No.: 103772  Prod. No.: 001 Rx (100MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityAug 24, 2005Orphan Designation: Treatment of Crohn's disease
Approved Labeled Indication: Treatment of moderately to severely active Crohn's disease for the reduction of the signs and symptoms, in patients who have an inadequate response to conventional therapies; and treatment of patients with fistulizing Crohn's disease for the reduction in the number of draining enterocutaneous fistula(s).
Exclusivity Type: Orphan Drug ExclusivityMay 19, 2013Orphan Designation: Treatment of pediatric (0 to 16 years of age) Crohn's Disease
Approved Labeled Indication: For reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy
Exclusivity Type: Orphan Drug ExclusivitySep 23, 2018Orphan Designation: Treatment of pediatric (0 to 16 years of age) ulcerative colitis
Approved Labeled Indication: For reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy

Repatha (Injection) (Subcutaneous) evolocumab
NDA Applicant: Amgen Inc.      BLA No.: 125522  Prod. No.: 001 Rx (140MG/ML); 002 Rx (140MG/ML); 003 Rx (420MG/3.5ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityAug 27, 2022Orphan Designation: Treatment of homozygous familial hypercholesterolemia
Approved Labeled Indication: As an adjunct to diet and other LDL-lowering therapies (e.g., statins, ezetimibe, LDL apheresis) in patients with HoFH who require additional lowering of LDL-C.
Exclusivity Protected Indication: As an adjunct to diet and other LDL-lowering therapies (e.g., statins, ezetimibe, LDL apheresis) in patients with HoFH who require additional lowering of LDL-C.
Exclusivity Type: Orphan Drug ExclusivitySep 24, 2028Orphan Designation: Treatment of homozygous familial hypercholesterolemia
Approved Labeled Indication: As an adjunct to other low-density lipoprotein cholesterol (LDL-C)-lowering therapies in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH), to reduce LDL-C
Exclusivity Protected Indication: to reduce LDL-C in pediatric patients aged 10 to less than 13 years with homozygous familial hypercholesterolemia (HoFH)

Rethymic (For Suspension) (Implantation) allogeneic processed thymus tissue-agdc
NDA Applicant: Enzyvant Therapeutics GmbH      BLA No.: 125685  Prod. No.: 001 Rx (SEMI-QUANTITATIVE)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityOct 8, 2028Orphan Designation: Treatment of congenital athymia
Approved Labeled Indication: immune reconstitution in pediatric patients with congenital athymia
Exclusivity Protected Indication: immune reconstitution in pediatric patients with congenital athymia
Exclusivity Type: Ref. Product ExclusivityOct 8, 2033 

Revcovi (Injection) (Intramuscular) elapegademase-lvlr
NDA Applicant: Chiesi USA, Inc.      BLA No.: 761092  Prod. No.: 001 Rx (2.4MG/1.5ML (1.6MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityOct 5, 2025Orphan 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.

Riastap (For Injection) (Intravenous) Fibrinogen Concentrate (Human)
NDA Applicant: CSL Behring GmbH      BLA No.: 125317  Prod. No.: 001 Rx (900-1300MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJan 16, 2016Orphan Designation: Treatment of fibrinogen deficient patients.
Approved Labeled Indication: Treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency (afibrinogenemia and hypofibrinogenemia)

Rituxan (Injection) (Intravenous) rituximab
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)
Exclusivity Type: Orphan Drug ExclusivityDec 2, 2028Orphan 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)

Rituxan (Injection) (Intravenous) rituximab
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)
Exclusivity Type: Orphan Drug ExclusivityDec 2, 2028Orphan 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)

Rituxan Hycela (Injection) (Subcutaneous) rituximab and hyaluronidase human
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 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 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 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.

Rixubis (For Injection) (Intravenous) Coagulation Factor IX (Recombinant)
NDA Applicant: Takeda Pharmaceuticals U.S.A., Inc.      BLA No.: 125446  Prod. No.: 001 Rx (500IU); 002 Rx (1000IU); 003 Rx (250IU); 004 Rx (3000IU); 005 Rx (2000IU)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivitySep 12, 2021Orphan 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.

Roctavian (Injection) (Intravenous) valoctocogene roxaparvovec-rvox
NDA Applicant: Biomarin Pharmaceutical Inc.      BLA No.: 125720  Prod. No.: 001 Rx (16X 10E13GENOMES PER ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJun 29, 2030Orphan Designation: Treatment of Hemophilia A.
Approved Labeled Indication: treatment of adults with severe hemophilia A (congenital factor VIII deficiency with factor VIII activity less than 1 IU/dL) without antibodies to adeno-associated virus serotype 5 (AAV5) detected by an FDA-approved test
Exclusivity Protected Indication: treatment of adults with severe hemophilia A (congenital factor VIII deficiency with factor VIII activity less than 1 IU/dL) without antibodies to adeno-associated virus serotype 5 (AAV5) detected by an FDA-approved test

Roferon-A (For Injection) (Subcutaneous) interferon alfa-2a
NDA Applicant: Hoffmann-La Roche Inc.      BLA No.: 103145  Prod. No.: 001 Disc (3MIU/0.5ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityNov 21, 1995Orphan Designation: Treatment of AIDS related Kaposi's sarcoma.

Ruconest (For Injection) (Intravenous) C1 Esterase Inhibitor (Recombinant)
NDA Applicant: Pharming Americas BV      BLA No.: 125495  Prod. No.: 001 Rx (2100IU)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJul 16, 2021Orphan Designation: Treatment of (acute attacks of) angioedema caused by hereditary or acquired C1-esterase inhibitor deficiency.
Approved Labeled Indication: Treatment of acute attacks of hereditary angioedema (HAE) in adult and adolescent patients.
Exclusivity Protected Indication: Treatment of acute attacks of hereditary angioedema (HAE) in adult and adolescent patients.
Exclusivity Type: Ref. Product ExclusivityJul 16, 2026 

Ryplazim (For Injection) (Intravenous) plasminogen, human-tvmh
NDA Applicant: ProMetic BioTherapeutics, Inc.      BLA No.: 125659  Prod. No.: 001 Rx (68.8MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJun 4, 2028Orphan Designation: Treatment of hypoplasminogenemia, or type I plasminogen deficiency
Approved Labeled Indication: Treatment of patients with plasminogen deficiency type 1 (hypoplasminogenemia).
Exclusivity Protected Indication: Treatment of patients with plasminogen deficiency type 1 (hypoplasminogenemia)
Exclusivity Type: Ref. Product ExclusivityJun 4, 2033 

Rystiggo (Injection) (Subcutaneous) rozanolixizumab-noli
NDA Applicant: UCB, Inc.      BLA No.: 761286  Prod. No.: 001 Rx (280MG/2ML (140MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJun 26, 2030Orphan 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


Last edited: 19 August 2023
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