Details for New Drug Application (NDA): 219122
NDA 219122 describes BRYNOVIN, which is a drug marketed by Azurity and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the BRYNOVIN profile page.
The generic ingredient in BRYNOVIN is sitagliptin hydrochloride. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the sitagliptin hydrochloride profile page.
The generic ingredient in BRYNOVIN is sitagliptin hydrochloride. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the sitagliptin hydrochloride profile page.
Summary for 219122
| Tradename: | BRYNOVIN |
| Applicant: | Azurity |
| Ingredient: | sitagliptin hydrochloride |
| Patents: | 2 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 219122
Generic Entry Date for 219122*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;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: 219122
| Mechanism of Action | Dipeptidyl Peptidase 4 Inhibitors |
Suppliers and Packaging for NDA: 219122
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BRYNOVIN | sitagliptin hydrochloride | SOLUTION;ORAL | 219122 | NDA | Azurity Pharmaceuticals, Inc. | 24338-017 | 24338-017-01 | 1 BOTTLE in 1 CARTON (24338-017-01) / 120 mL in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;ORAL | Strength | EQ 25MG BASE/ML | ||||
| Approval Date: | Jan 16, 2025 | TE: | RLD: | Yes | |||||
| Patent: | 11,944,621 | Patent Expiration: | Oct 23, 2040 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 12,295,953 | Patent Expiration: | Oct 23, 2040 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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