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 |
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Exclusivity Type: Orphan Drug Exclusivity | Mar 18, 2023 | Orphan 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
NDA Applicant: Genentech, Inc. BLA No.: 125486 Prod. No.: 001 Rx (1,000MG/40ML (25MG/ML))
Exclusivity | Expiration | Exclusivity Description |
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Exclusivity Type: Orphan Drug Exclusivity | Nov 1, 2020 | Orphan 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 Exclusivity | Feb 26, 2023 | Orphan 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 Exclusivity | Nov 16, 2024 | Orphan 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
NDA Applicant: Novartis Pharmaceuticals Corporation BLA No.: 125326 Prod. No.: 001 Disc (100MG/5ML); 002 Disc (1,000MG/50ML)
Exclusivity | Expiration | Exclusivity Description |
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Exclusivity Type: Orphan Drug Exclusivity | Oct 26, 2016 | Orphan Designation: Treatment of chronic lymphocytic leukemia Approved Labeled Indication: Treatment of chronic lymphocytic leukemia (CLL) refractory to alemtuzumab and fludarabine |
Exclusivity Type: Orphan Drug Exclusivity | Apr 17, 2021 | Orphan 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 Exclusivity | Jan 19, 2023 | Orphan 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
NDA Applicant: Eli Lilly and Company BLA No.: 761038 Prod. No.: 001 Disc (500MG/50ML (10MG/ML)); 002 Disc (190MG/19ML (10MG/ML))
Exclusivity | Expiration | Exclusivity Description |
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Exclusivity Type: Orphan Drug Exclusivity | Feb 25, 2020 | 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. |
olipudase alfa-rpcp (For Injection) (Intravenous) Xenpozyme
NDA Applicant: Genzyme Corporation BLA No.: 761261 Prod. No.: 001 Rx (20MG); 002 Rx (4MG)
Exclusivity | Expiration | Exclusivity Description |
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Exclusivity Type: Orphan Drug Exclusivity | Aug 31, 2029 | Orphan Designation: Treatment of acid sphingomyelinase deficiency (Niemann-Pick disease) Approved Labeled Indication: Treatment of non-central nervous system manifestations of acid sphingomyelinase deficiency (ASMD) in adult and pediatric patients Exclusivity Protected Indication: Treatment of non-central nervous system manifestations of acid sphingomyelinase deficiency (ASMD) in adult and pediatric patients |
omidubicel-onlv (For Injection) (Intravenous) OMISIRGE
NDA Applicant: Gamida Cell Ltd. BLA No.: 125738 Prod. No.: 001 Rx (>4.0x10^8 total viable cells, >2.4x10^7 CD3+ cells with 41mL dil sol); 002 Rx (>8.0x10^8 total viable cells, >8.7% CD34+ cells, >9.2x10^7 CD34+ cells with 81mL dil so)
Exclusivity | Expiration | Exclusivity Description |
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Exclusivity Type: Orphan Drug Exclusivity | Apr 17, 2030 | Orphan Designation: Enhancement of cell engraftment and immune reconstitution in patients receiving hematopoietic stem cell transplant Approved Labeled Indication: for use in adults and pediatric patients 12 years and older with hematologic malignancies who are planned for umbilical cord blood transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infection Exclusivity Protected Indication: for use in adults and pediatric patients 12 years and older with hematologic malignancies who are planned for umbilical cord blood transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infection |
onabotulinumtoxinA (For Injection) (Intramuscular; Injection, Intramuscular, Intradermal, Intradetrusor) Botox Cosmetic
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)
Exclusivity | Expiration | Exclusivity Description |
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Exclusivity Type: Orphan Drug Exclusivity | Jun 20, 2026 | 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. |
onasemnogene abeparvovec-xioi (Injection) (Intravenous) Zolgensma
NDA Applicant: Novartis Gene Therapies, Inc. BLA No.: 125694 Prod. No.: 001 Rx (1.1X10E14 VG/KG VG/KG=VECTOR GENOMES PER KILOGRAM)
Exclusivity | Expiration | Exclusivity Description |
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Exclusivity Type: Orphan Drug Exclusivity | May 24, 2026 | Orphan 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 Exclusivity | May 24, 2031 |
oprelvekin (For Injection) (Subcutaneous) Neumega
NDA Applicant: Wyeth Pharmaceuticals Inc. BLA No.: 103694 Prod. No.: 001 Disc (5MG)
Exclusivity | Expiration | Exclusivity Description |
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Exclusivity Type: Orphan Drug Exclusivity | Nov 25, 2004 | Orphan Designation: Prevention of severe chemotherapy-induced thrombocytopenia. |