Generic names starting with "O"

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.


obiltoxaximab (Injection) (Intravenous) Anthim
Drug Classes: monoclonal antibody directed against the protective antigen of Bacillus anthracis
NDA Applicant: Elusys Therapeutics, Inc.      BLA No.: 125509  Prod. No.: 001 Rx (600MG/6ML (100MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMar 18, 2023Orphan Designation: Treatment of exposure to B. anthracis spores
Approved Labeled Indication: Treatment of adult and pediatric patients with inhalational anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs and for prophylaxis of inhalational anthrax due to B. anthracis when alternative therapies are not available or are not appropriate.
Exclusivity Protected Indication: 1) Treatment of adult and pediatric patients with inhalational anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs, and (2) for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate.

obinutuzumab (Injection) (Intravenous) Gazyva
Drug Classes: Antineoplastics:Monoclonal Antibody/Antibody-Drug Conjugate == CD20-directed cytolytic antibody
NDA Applicant: Genentech, Inc.      BLA No.: 125486  Prod. No.: 001 Rx (1,000MG/40ML (25MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityNov 1, 2020Orphan Designation: Treatment of chronic lymphocytic leukemia
Approved Labeled Indication: GAZYVA, in combination with chlorambucil, is indicated for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL).
Exclusivity Protected Indication: Treatment of patients with previously untreated chronic lymphocytic leukemia in combination with chlorambucil.
Exclusivity Type: Orphan Drug ExclusivityFeb 26, 2023Orphan Designation: Treatment of follicular lymphoma
Approved Labeled Indication: GAZYVA, in combination with bendamustine followed by GAZYVA monotherapy, is indicated for the treatment of patients with follicular lymphoma (FL) who relapsed after, or are refractory to, a rituximab-containing regimen
Exclusivity Protected Indication: in combination with bendamustine followed by Gazyva monotherapy, indicated for the treatment of patients with follicular lymphoma (FL) who relapsed after, or are refractory to, a rituximab-containing regimen.
Exclusivity Type: Orphan Drug ExclusivityNov 16, 2024Orphan Designation: Treatment of follicular lymphoma
Approved Labeled Indication: GAZYVA, in combination with bendamustine followed by GAZYVA monotherapy, is indicated for the treatment of patients with follicular lymphoma (FL) who relapsed after, or are refractory to, a rituximab-containing regimen; and in combination with chemotherapy followed by GAZYVA monotherapy in patients achieving at least a partial remission for the treatment of adult patients with previously untreated stage II bulky, III or IV follicular lymphoma
Exclusivity Protected Indication: In combination with chemotherapy followed by GAZYVA monotherapy in patients achieving at least a partial remission for the treatment of adult patients with previously untreated stage II bulky, III or IV follicular lymphoma.

ofatumumab (Injection) (Intravenous) Arzerra
Drug Classes: Antineoplastics:Monoclonal Antibody/Antibody-Drug Conjugate == CD20-directed cytolytic antibody
NDA Applicant: Novartis Pharmaceuticals Corporation      BLA No.: 125326  Prod. No.: 001 Rx (100MG/5ML); 002 Rx (1,000MG/50ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityOct 26, 2016Orphan Designation: Treatment of chronic lymphocytic leukemia
Approved Labeled Indication: Treatment of chronic lymphocytic leukemia (CLL) refractory to alemtuzumab and fludarabine
Exclusivity Type: Orphan Drug ExclusivityApr 17, 2021Orphan Designation: Treatment of chronic lymphocytic leukemia
Approved Labeled Indication: ARZERRA (ofatumumab) is indicated, in combination with chlorambucil, for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL) for whom fludarabine-based therapy is considered inappropriate.
Exclusivity Protected Indication: Ofatumumab in combination with chlorambucil, for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL) for whom fludarabine-based therapy is considered inappropriate.
Exclusivity Type: Orphan Drug ExclusivityJan 19, 2023Orphan Designation: Treatment of chronic lymphocytic leukemia
Approved Labeled Indication: For extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive CLL.
Exclusivity Protected Indication: For extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive CLL.

olaratumab (Injection) (Intravenous) Lartruvo
Drug Classes: Antineoplastics:Monoclonal Antibody/Antibody-Drug Conjugate
NDA Applicant: Eli Lilly and Company      BLA No.: 761038  Prod. No.: 001 Disc (500MG/50ML (10MG/ML)); 002 Disc (190MG/19ML (10MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityFeb 25, 2020Orphan 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.

onabotulinumtoxinA (For Injection) (Intramuscular; Injection, Intramuscular, Intradermal, Intradetrusor) Botox Cosmetic
Drug Classes: Dermatological Agents:Dermatological Agents, Other
NDA Applicant: Allergan, Inc.      BLA No.: 103000  Prod. No.: 001 Rx (50UNITS); 002 Rx (100UNITS); 004 Rx (100UNITS); 005 Rx (200UNITS) BLA No.: 103000  Prod. No.: 003 Disc (50UNITS)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJun 20, 2026Orphan 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.

onasemnogene abeparvovec-xioi (Injection) (Intravenous) Zolgensma
Drug Classes: Genetic, Enzyme, or Protein Disorder: Replacement, Modifiers, Treatment
NDA Applicant: Novartis Gene Therapies, Inc.      BLA No.: 125694  Prod. No.: 001 Rx (1.1X10E14 VG/KG VG/KG=VECTOR GENOMES PER KILOGRAM)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMay 24, 2026Orphan Designation: Treatment of spinal muscular atrophy
Approved Labeled Indication: Indicated for the treatment of pediatric patients less than 2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene.
Exclusivity Protected Indication: Indicated for the treatment of pediatric patients less than 2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene.
Exclusivity Type: Ref. Product ExclusivityMay 24, 2031 

oprelvekin (For Injection) (Subcutaneous) Neumega
Drug Classes: megakaryocyte growth factor
NDA Applicant: Wyeth Pharmaceuticals Inc.      BLA No.: 103694  Prod. No.: 001 Disc (5MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityNov 25, 2004Orphan Designation: Prevention of severe chemotherapy-induced thrombocytopenia.



Last edited: 15 November 2022
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