Details for New Drug Application (NDA): 213137
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NDA 213137 describes OXBRYTA, which is a drug marketed by Global Blood Theraps and is included in two NDAs. It is available from one supplier. There are eleven patents protecting this drug. Additional details are available on the OXBRYTA profile page.
The generic ingredient in OXBRYTA is voxelotor. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the voxelotor profile page.
The generic ingredient in OXBRYTA is voxelotor. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the voxelotor profile page.
Summary for 213137
| Tradename: | OXBRYTA |
| Applicant: | Global Blood Theraps |
| Ingredient: | voxelotor |
| Patents: | 11 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 213137
Generic Entry Date for 213137*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;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: 213137
| Mechanism of Action | Cytochrome P450 3A4 Inhibitors Hemoglobin S Polymerization Inhibitors |
Suppliers and Packaging for NDA: 213137
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OXBRYTA | voxelotor | TABLET;ORAL | 213137 | NDA | Global Blood Therapeutics, Inc, A subsidiary of Pfizer Inc. | 72786-101 | 72786-101-01 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72786-101-01) |
| OXBRYTA | voxelotor | TABLET;ORAL | 213137 | NDA | Global Blood Therapeutics, Inc, A subsidiary of Pfizer Inc. | 72786-102 | 72786-102-02 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72786-102-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
| Approval Date: | Nov 25, 2019 | 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, 2026 | ||||||||
| Regulatory Exclusivity Use: | INDICATED FOR THE TREATMENT OF SICKLE CELL DISEASE (SCD) IN ADULTS AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Dec 28, 2032 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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