Details for New Drug Application (NDA): 216157
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The generic ingredient in OXBRYTA is voxelotor. One supplier is listed for this compound. Additional details are available on the voxelotor profile page.
Summary for 216157
Tradename: | OXBRYTA |
Applicant: | Global Blood Theraps |
Ingredient: | voxelotor |
Patents: | 10 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 216157
Generic Entry Date for 216157*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET, FOR SUSPENSION;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 216157
Mechanism of Action | Cytochrome P450 3A4 Inhibitors Hemoglobin S Polymerization Inhibitors |
Suppliers and Packaging for NDA: 216157
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
OXBRYTA | voxelotor | TABLET, FOR SUSPENSION;ORAL | 216157 | NDA | Global Blood Therapeutics, Inc, A subsidiary of Pfizer Inc. | 72786-111 | 72786-111-02 | 60 TABLET, FOR SUSPENSION in 1 BOTTLE, PLASTIC (72786-111-02) |
OXBRYTA | voxelotor | TABLET, FOR SUSPENSION;ORAL | 216157 | NDA | Global Blood Therapeutics, Inc, A subsidiary of Pfizer Inc. | 72786-111 | 72786-111-03 | 90 TABLET, FOR SUSPENSION in 1 BOTTLE, PLASTIC (72786-111-03) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, FOR SUSPENSION;ORAL | Strength | 300MG | ||||
Approval Date: | Dec 17, 2021 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Dec 17, 2028 | ||||||||
Regulatory Exclusivity Use: | FOR TREATMENT OF SICKLE CELL DISEASE (SCD) IN PEDIATRIC PATIENTS 4 YEARS OF AGE TO LESS THAN 12 YEARS OF AGE | ||||||||
Regulatory Exclusivity Expiration: | Nov 25, 2024 | ||||||||
Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
Patent: | ⤷ Subscribe | Patent Expiration: | Dec 28, 2032 | Product Flag? | Y | Substance Flag? | Delist Request? |
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