Orange Book product · Brand (NDA)

BRYNOVIN

SITAGLIPTIN HYDROCHLORIDE

Brand (NDA)NDA 219122RX AZURITY

Jan 16, 2025

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jan 16, 2025
1 yr 5 mo ago
Today
Patent 11944621 expires
Listed drug product patent expiration.
Oct 23, 2040
in 14 yr 7 mo
Patent 12295953 expires
Listed drug product patent expiration.
Oct 23, 2040
in 14 yr 7 mo

Active ingredient

SITAGLIPTIN HYDROCHLORIDE

Strength

EQ 25MG BASE/ML

Dosage form

SOLUTION

Route

ORAL

TE code

Not listed

Application

NDA 219122

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
11944621	Oct 23, 2040	in 14 yr 7 mo	Product
12295953	Oct 23, 2040	in 14 yr 7 mo	Product