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OMEPRAZOLE

NDA

OMEPRAZOLE | N022032 | DEXCEL PHARMA TECHNOLOGIES LTD

1 strength1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Active (1)Today

2027

2028

2029

2030

Today

12599565

Jan. 31, 2030

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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
DEXCEL PHARMA TECHNOLOGIES LTD. et al v. SUN PHARMA GLOBAL FZE et al 2:2015cv08017 2 patentsANDA 207891omeprazole	D.N.J.	2015-11-11	Terminated 2018-08-07	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

7 petitions (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Alliance For Natural Health USA FDA-2020-P-1540 · 5 docket documents Alliance for Natural Health USA filed this citizen petition requesting that the Food and Drug Administration issue a regulation requiring all manufacturers of proton pump inhibitor medications, including omeprazole, lansoprazole, pantoprazole, rabeprazole, esomeprazole, and dexlansoprazole, to expan	505(q)	2020-06-11	Denied	Alliance For Natural Health USA
Suitability Petition from Aurora Pharmaceutical LLC 2 FDA-2017-P-1225 · 4 docket documents Aurora Pharmaceutical LLC submitted this petition under Section 512(n)(3) of the Federal Food, Drug and Cosmetic Act in February 2017 requesting FDA permission to file an abbreviated new animal drug application for Omeprazole Suspension 4.5% w/v, a generic version of the reference listed drug Gastro	Suitability	2017-02-28	Open	Aurora Pharmaceutical LLC 2
Dinsmore & Shohl, LLP - Citizen Petition FDA-2010-P-0638 · 6 docket documents Dinsmore & Shohl, LLP filed a petition on behalf of an unnamed client under Section 512(n)(3) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine a new palatable tablet dosage form of omeprazole for horses is suitable for submission as an abbreviated new animal drug applica	Other	2010-12-20	Granted	—
Precision Consultants, Inc. - Citizen Petition FDA-2009-P-0450 · 6 docket documents Precision Consultants, Inc. filed this suitability petition under Section 512(n)(3) of the Federal Food, Drug, and Cosmetic Act requesting FDA approval to submit an abbreviated new animal drug application (ANADA) for omeprazole palatable tablets for horses at a new strength of 570 mg per tablet, dif	Other	2009-09-28	Denied	—
Mattingly, Stanger & Malur, P.C. - Citizen Petition FDA-2003-P-0224 · 4 docket documents The law firm Mattingly, Stanger & Malur, P.C. filed this citizen petition under 21 CFR 10.30 and 10.35(b) requesting that the FDA amend its NDA approval for Prilosec OTC (omeprazole magnesium), a nonprescription heartburn treatment approved on June 20, 2003, to require marketing under a different br	Other	2009-01-05	Denied	—
Procter & Gamble Company - Citizen Petition FDA-2008-P-0654 · 7 docket documents Procter & Gamble Company filed this citizen petition pursuant to 21 CFR 10.30 and 21 USC 355 requesting that FDA refrain from approving an over-the-counter version of Zegerid (omeprazole/sodium bicarbonate) if it bears the phrase "immediate release" or "IR" on the label, lacks a prominent disclaimer	505(q) Stay Request	2008-12-30	Denied	—
Proctor & Gamble Company - Citizen Petition FDA-2008-P-0599 · 7 docket documents The Procter & Gamble Company filed this citizen petition pursuant to 21 C.F.R. § 10.30 and 21 U.S.C. § 355, requesting that FDA refrain from granting effective approval of an over-the-counter version of Zegerid (omeprazole/sodium bicarbonate) that bears the phrase "immediate release" or uses the acr	505(q)	2008-12-02	Withdrawn	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

256 trials from ClinicalTrials.gov — 2 recruiting, 2 active, 198 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Proton Pump Inhibitor (PPI) Response in Eosinophilic Esophagitis Assessed by Transnasal Endoscopy (TNE)NCT04149470	Phase 4	Active	University of Colorado, Denver	90	2020-10-07 → 2024-08
Effects of H. Pylori Eradication on the Gastric Preneoplastic Lesion and Neoplasm After ESD NCT02407119	Phase 3	Active	National Cancer Center, Korea	470	2003-06 → 2030-06
EFFICACY OF ORAL AROEIRA (Schinus Terebinthifolia Raddi) COMPARED TO OMEPRAZOLE IN DYSPEPPSIA NCT04069286	Phase 3	Not Yet Recruiting	Infan Industria Quimica Farmaceutica Nacional	474	2025-03 → 2027-03
Fatty Acid Synthase Inhibition in Castration Refractory Prostate Cancer NCT04337580	Phase 2	Recruiting	Wake Forest University Health Sciences	50	2021-03-05 → 2028-03
Factors Influencing the Human Gut Microbiome Profile in Multi-ethnic Groups of the Singapore Community (FAMES)NCT02893709	N/A	Completed	Changi General Hospital	36	2015-06 → 2016-07
Traditional Chinese Medicine Combined With Standard Triple Region for Eradication of Helicobacter Pylori NCT02803216	Phase 1/2	Completed	Xiyuan Hospital of China Academy of Chinese Medical Sciences	576	2013-01 → 2016-04
Pharmacokinetic Study to Evaluate the Effect of a Single Dose of Guselkumab (CNTO 1959) on CYP 450 Enzyme Activities After Subcutaneous Administration in Participants With Psoriasis NCT02397382	Phase 1	Completed	Janssen Research & Development, LLC	16	2015-06-18 → 2016-08-31
A Phase 1 Study to Evaluate the Effects of Omeprazole and Famotidine on the Absorption of Telotristat Ethyl in Healthy Subjects NCT03302845	Phase 1	Completed	Lexicon Pharmaceuticals	32	2017-09-21 → 2017-11-07
Assess the Influence of Cenobamate on the PK of Cytochrome P450 (CYP) Probe Drugs As a Means of Predicting Drug-drug Interactions NCT03234699	Phase 1	Completed	SK Life Science, Inc.	24	2017-02-22 → 2017-07-31
Safety and Efficacy of Oral Administration of Anti-CD3 Monoclonal Antibody (mAb)in Patients With the Metabolic Syndrome NCT01205087	Phase 2	Completed	Hadassah Medical Organization	36	2010-09 → 2011-04

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 18 NDCs

Highest NADAC/Unit

$0.3997

per ea

Lowest NADAC/Unit

$0.3997

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
70677110401FT OMEPRAZOLE DR 20 MG TABLET	$0.3997	EA	Generic	—	2026-06-17
70677110402FT OMEPRAZOLE DR 20 MG TABLET	$0.3997	EA	Generic	—	2026-06-17
45802088830OMEPRAZOLE DR 20 MG TABLET	$0.3997	EA	Generic	—	2026-06-17
45802088855OMEPRAZOLE DR 20 MG TABLET	$0.3997	EA	Generic	—	2026-06-17
00113091530GS OMEPRAZOLE DR 20 MG TABLET	$0.3997	EA	Generic	—	2026-06-17
00113091555GS OMEPRAZOLE DR 20 MG TABLET	$0.3997	EA	Generic	—	2026-06-17

Showing 6 of 18 NDCs.

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

API Supply Chain34 active DMFs17 inactive

27 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

DR REDDYS LABORATORIES LTDOMEPRAZOLE, USP

DMF 129171998

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

MURLI KRISHNA PHARMA PVT LTDOMEPRAZOLE PELLETS 8.5 % W/W

DMF 274112013

YUNG SHIN PHARMACEUTICAL INDUSTRIAL CO LTDOMEPRAZOLE, USP

DMF 283102014

EVEREST ORGANICS LTDOMEPRAZOLE CHLORO COMPOUND

DMF 290052015

RAKS PHARMA PVT LTDOMEPRAZOLE, USP

DMF 294022015

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

21 letters from Drugs@FDA

Date	Submission	Document
Oct 6, 2025	SUPPL -70	View Letter (PDF)
Nov 12, 2024	SUPPL -65	View Letter (PDF)
Oct 13, 2022	SUPPL -52	View Letter (PDF)
Oct 3, 2022	SUPPL -57	View Letter (PDF)
Jul 8, 2021	SUPPL -46	View Letter (PDF)
Apr 10, 2019	SUPPL -41	View Letter (PDF)
Nov 15, 2017	SUPPL -38	View Letter (PDF)
Nov 6, 2017	SUPPL -37	View Letter (PDF)
Feb 11, 2016	SUPPL -32	View Letter (PDF)
Jun 12, 2015	SUPPL -29	View Letter (PDF)
Mar 10, 2015	SUPPL -24	View Letter (PDF)
Aug 20, 2013	SUPPL -21	View Letter (PDF)
Oct 30, 2012	SUPPL -20	View Letter (PDF)
Sep 11, 2012	SUPPL -19	View Letter (PDF)
Apr 11, 2012	SUPPL -16	View Letter (PDF)
Jul 5, 2011	SUPPL -12	View Letter (PDF)
Jul 23, 2010	SUPPL -8	View Letter (PDF)
Jul 23, 2009	SUPPL -3	View Letter (PDF)
Apr 7, 2009	SUPPL -3	View Letter (PDF)
Jan 9, 2008	ORIG -1	View Letter (PDF)
Jul 5, 2007	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 20MG

RLD

1 patent0 exclusivities▴

TABLET, DELAYED RELEASE;ORAL | Approved: Dec 4, 2007

Patents (1)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
12599565	Jan 31, 2030	—	—	Yes	—	—