Details for New Drug Application (NDA): 214373
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NDA 214373 describes BRENZAVVY, which is a drug marketed by Theracosbio and is included in one NDA. It is available from two suppliers. There are seven patents protecting this drug. Additional details are available on the BRENZAVVY profile page.
The generic ingredient in BRENZAVVY is bexagliflozin. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the bexagliflozin profile page.
The generic ingredient in BRENZAVVY is bexagliflozin. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the bexagliflozin profile page.
Summary for 214373
| Tradename: | BRENZAVVY |
| Applicant: | Theracosbio |
| Ingredient: | bexagliflozin |
| Patents: | 7 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 214373
Generic Entry Date for 214373*:
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: 214373
| Mechanism of Action | Sodium-Glucose Transporter 2 Inhibitors |
Suppliers and Packaging for NDA: 214373
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BRENZAVVY | bexagliflozin | TABLET;ORAL | 214373 | NDA AUTHORIZED GENERIC | Golden State Medical Supply, Inc. | 51407-918 | 51407-918-30 | 30 TABLET in 1 BOTTLE (51407-918-30) |
| BRENZAVVY | bexagliflozin | TABLET;ORAL | 214373 | NDA AUTHORIZED GENERIC | Golden State Medical Supply, Inc. | 51407-918 | 51407-918-90 | 90 TABLET in 1 BOTTLE (51407-918-90) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
| Approval Date: | Jan 20, 2023 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jan 20, 2028 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | 10,533,032 | Patent Expiration: | Jul 3, 2031 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES | ||||||||
| Patent: | 10,981,942 | Patent Expiration: | Jun 13, 2031 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
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