Viewing data from:

BRYNOVIN

NDA

SITAGLIPTIN HYDROCHLORIDE | N219122 | AZURITY PHARMACEUTICALS INC

1 strength2 unique patents0 unique exclusivities

Patent Timeline

2 unique patents by expiration date

Active (2)Today

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

2040

2041

Today

11944621

Oct. 23, 2040

12295953

Oct. 23, 2040

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain7 active DMFs

6 active API suppliers hold Drug Master Files for this ingredient.

DR REDDYS LABORATORIES LTDSITAGLIPTIN HYDROCHLORIDE (MONOHYDRATE)

DMF 344002019

ZAKLADY FARMACEUTYCZNE POLPHARMA SASITAGLIPTIN HYDROCHLORIDE MONOHYDRATE

DMF 361292021

BIOCON LTDSITAGLIPTIN HYDROCHLORIDE

DMF 365582022

HIKAL LTDSITAGLIPTIN HYDROCHLORIDE (PROCESS B)

DMF 372882022

BIOCON LTDSITAGLIPTIN HYDROCHLORIDE (ENZYMATIC)

DMF 376842024

ZHEJIANG JINGSHENG PHARMACEUTICAL CO LTDSITAGLIPTIN HYDROCHLORIDE

DMF 394402024

RUYUAN HEC PHARM CO LTDSITAGLIPTIN HYDROCHLORIDE MONOHYDRATE NON-STERILE BULK DRUG SUBSTANCE

DMF 425212025

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jan 17, 2025	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 25MG BASE/ML

RLD

2 patents0 exclusivities▴

SOLUTION;ORAL | Approved: Jan 16, 2025

Patents (2)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
11944621	Oct 23, 2040	—	—	Yes	—	—
12295953	Oct 23, 2040	—	—	Yes	—	—