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OMEPRAZOLE

NDA

OMEPRAZOLE | N209400 | DEXCEL PHARMA TECHNOLOGIES LTD

1 strength2 unique patents0 unique exclusivities

Patent Timeline

2 unique patents by expiration date

Active (2)Today

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10076494

Dec. 8, 2036

10835488

Dec. 8, 2036

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 Chain32 active DMFs17 inactive

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

ESTEVE QUIMICA SAOMEPRAZOLE

DMF 117941995

QUIMICA SINTETICA SAOMEPRAZOLE

DMF 126051997

ASTRAZENECA ABOMEPRAZOLE MAGNESIUM DRUG SUBSTANCE

DMF 127261997

CIPLA LTDOMEPRAZOLE USP

DMF 128271998

HETERO DRUGS LTDOMEPRAZOLE

DMF 150242000

UNION QUIMICO FARMACEUTICA SA (UQUIFA SA)OMEPRAZOLE

DMF 172552004

DR REDDYS LABORATORIES LTDOMEPRAZOLE (FORM B) USP

DMF 197132006

APITORIA PHARMA PRIVATE LTDOMEPRAZOLE USP (NON-STERILE DRUG SUBSTANCE)

DMF 212232007

NATCO PHARMA LTDOMEPRAZOLE

DMF 213102008

LUPIN LTDOMEPRAZOLE USP

DMF 214982008

ZYDUS LIFESCIENCES LTDOMEPRAZOLE USP (FORM-B)

DMF 217932008

SRINI PHARMACEUTICALS PRIVATE LTDOMEPRAZOLE USP

DMF 224712009

SHOUGUANG FUKANG PHARMACEUTICAL CO LTDOMEPRAZOLE

DMF 228972009

ZHEJIANG JINHUA CONBA BIO-PHARM CO LTDOMEPRAZOLE

DMF 241182010

DR REDDYS LABORATORIES LTDOMEPRAZOLE [PROCESS-II]

DMF 246402011

SHOUGUANG FUKANG PHARMACEUTICAL CO LTDOMEPRAZOLE

DMF 249232011

TAPI NL BVOMEPRAZOLE

DMF 256212011

HETERO DRUGS LTDOMEPRAZOLE USP (FORM B)

DMF 257122012

SUN PHARMACEUTICAL INDUSTRIES LTDOMEPRAZOLE USP

DMF 267962013

RAKS PHARMA PVT LTDOMEPRAZOLE MAGNESIUM, USP

DMF 271902013

MURLI KRISHNA PHARMA PVT LTDOMEPRAZOLE PELLETS 8.5 % W/W

DMF 274112013

EVEREST ORGANICS LTDOMEPRAZOLE CHLORO COMPOUND

DMF 290052015

ALIVUS LIFE SCIENCES LTDOMEPRAZOLE USP

DMF 296332015

STERILE INDIA PVT LTDOMEPRAZOLE SODIUM (STERILE)

DMF 299812016

JINZHOU JIUTAI PHARMACEUTICAL CO LTDOMEPRAZOLE SODIUM

DMF 334022018

METROCHEM API PRIVATE LTDOMEPRAZOLE USP

DMF 347592020

EVEREST ORGANICS LTDOMEPRAZOLE USP

DMF 371552022

GRANULES INDIA LTDOMEPRAZOLE USP

DMF 374492022

LEE PHARMA LTDOMEPRAZOLE

DMF 379212023

CHROMO LABORATORIES INDIA PRIVATE LTDOMEPRAZOLE

DMF 385862024

EVEREST ORGANICS LTDOMEPRAZOLE SULPHIDE

DMF 385882023

CIPLA LTDOMEPRAZOLE USP PROCESS-II

DMF 408942024

ASTRA RESEARCH LABORATORIESInactiveOMEPRAZOLE CAPSULES

DMF 48631983

ESTEVE QUIMICA SAInactiveOMEPRAZOLE

DMF 110171994

UNION QUIMICO FARMACEUTICA SA (UQUIFA SA)InactiveOMEPRAZOLE

DMF 115511995

WOCKHARDT LTDInactiveOMEPRAZOLE

DMF 142861999

SANYO FINE CO LTDInactiveOMEPRAZOLE

DMF 149692000

UNION QUIMICO FARMACEUTICA SA (UQUIFA SA)InactiveOMEPRAZOLE (SIEVED)

DMF 158042002

LEK PHARMACEUTICAL AND CHEMICAL CO DDInactiveOMEPRAZOLE ACTIVE DRUG SUBSTANCE

DMF 159472002

SCINOPHARM TAIWAN LTDInactiveOMEPRAZOLE USP

DMF 159492002

SANDOZ SYNTEK ILAC HAMMADDELERI SANAYI VE TICARET ASInactiveOMEPRAZOLE

DMF 171262004

SCINOPHARM TAIWAN LTDInactiveOMEPRAZOLE

DMF 173922004

VENKAT PHARMA LTDInactiveOMEPRAZOLE PELLETS 8.5% W/W

DMF 183342005

CADILA HEALTHCARE LTDInactiveOMEPRAZOLE

DMF 185012005

BELCHER PHARMACEUTICALS INCInactiveOMEPRAZOLE PELLETS (8.5% W/W)

DMF 189922005

CIPLA LTDInactiveOMEPRAZOLE SODIUM

DMF 201692007

DISHMAN CARBOGEN AMCIS LTDInactiveOMEPRAZOLE

DMF 232192009

IOL CHEMICALS AND PHARMACEUTICALS LTDInactiveOMEPRAZOLE

DMF 262622012

METROCHEM API PRIVATE LTDInactiveOMEPRAZOLE

DMF 279282014

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

Approval Letters

10 letters from Drugs@FDA

Date	Submission	Document
Mar 12, 2026	SUPPL -21	View Letter (PDF)
Oct 24, 2022	SUPPL -12	View Letter (PDF)
Jul 8, 2021	SUPPL -6	View Letter (PDF)
Nov 17, 2020	SUPPL -10	View Letter (PDF)
Apr 30, 2020	SUPPL -7	View Letter (PDF)
Feb 13, 2019	SUPPL -5	View Letter (PDF)
Jul 16, 2018	SUPPL -3	View Letter (PDF)
Jun 14, 2018	SUPPL -2	View Letter (PDF)
Mar 1, 2018	SUPPL -1	View Letter (PDF)
Jul 11, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 20MG

RLD

2 patents0 exclusivities▴

TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL | Approved: Jul 5, 2017

Patents (2)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
10076494	Dec 8, 2036	—	—	Yes	—	—
10835488	Dec 8, 2036	—	—	Yes	—	—