OMEPRAZOLE - Generic Drug Details

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What are the generic drug sources for omeprazole and what is the scope of freedom to operate?

Omeprazole is the generic ingredient in eight branded drugs marketed by Actavis Labs Fl Inc, Apotex, Aurobindo Pharma, Breckenridge, Dr Reddys Labs Ltd, Glenmark Pharms Ltd, Hetero Labs Ltd Iii, Impax Labs, Lannett Co Inc, Lupin Ltd, Norvium Bioscience, Sandoz, Strides Pharma, Teva Pharms Usa, Xiromed, Zydus Pharms Usa Inc, Astrazeneca, Dexcel Pharma, Dr Reddys, Sun Pharm, Dexcel, Aurobindo Pharma Ltd, L Perrigo Co, Spil, Covis, P And L, Perrigo R And D, Ajanta Pharma Ltd, Anda Repository, Aurolife Pharma Llc, Chartwell Rx, Sciegen Pharms Inc, Zydus, Zydus Pharms, Salix, Riley Consumer, and Azurity, and is included in fifty-four NDAs. There are nine patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Omeprazole has thirteen patent family members in eight countries.

There are one hundred and thirty-one drug master file entries for omeprazole. Ninety-nine suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for OMEPRAZOLE

International Patents:	13
US Patents:	9
Tradenames:	8
Applicants:	37
NDAs:	54
Drug Master File Entries:	131
Finished Product Suppliers / Packagers:	99
Raw Ingredient (Bulk) Api Vendors:	225
Clinical Trials:	445
Patent Applications:	6,793
Drug Prices:	Drug price trends for OMEPRAZOLE
Drug Sales Revenues:	Drug sales revenues for OMEPRAZOLE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for OMEPRAZOLE
What excipients (inactive ingredients) are in OMEPRAZOLE?	OMEPRAZOLE excipients list
DailyMed Link:	OMEPRAZOLE at DailyMed

See drug prices for OMEPRAZOLE

Drug Sales Revenue Trends for OMEPRAZOLE

See drug sales revenues for OMEPRAZOLE

Recent Clinical Trials for OMEPRAZOLE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Jacobio Pharmaceuticals Co., Ltd.	Phase 1
Karolinska Institutet	Phase 4
Nationwide Children's Hospital	N/A

See all OMEPRAZOLE clinical trials

Generic filers with tentative approvals for OMEPRAZOLE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	40MG	CAPSULE, DELAYED REL PELLETS;ORAL
⤷ Sign Up	⤷ Sign Up	20MG	CAPSULE, DELAYED REL PELLETS;ORAL
⤷ Sign Up	⤷ Sign Up	10MG	CAPSULE, DELAYED REL PELLETS;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for OMEPRAZOLE

Drug Class	Proton Pump Inhibitor
Mechanism of Action	Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors

Medical Subject Heading (MeSH) Categories for OMEPRAZOLE

Anti-Ulcer Agents
Proton Pump Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for OMEPRAZOLE

A02BC	Proton pump inhibitors
A02B	DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
A02	DRUGS FOR ACID RELATED DISORDERS
A	Alimentary tract and metabolism

Paragraph IV (Patent) Challenges for OMEPRAZOLE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
OMEPRAZOLE	Delayed-release Tablets	omeprazole	20 mg	022032	1	2015-06-03

US Patents and Regulatory Information for OMEPRAZOLE

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Dexcel Pharma	OMEPRAZOLE	omeprazole	TABLET, DELAYED RELEASE;ORAL	022032-001	Dec 4, 2007		OTC	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Impax Labs	OMEPRAZOLE	omeprazole	CAPSULE, DELAYED REL PELLETS;ORAL	075785-001	Oct 22, 2007	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Zydus Pharms	OMEPRAZOLE AND SODIUM BICARBONATE	omeprazole; sodium bicarbonate	CAPSULE;ORAL	203290-002	May 25, 2018	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sciegen Pharms Inc	OMEPRAZOLE AND SODIUM BICARBONATE	omeprazole; sodium bicarbonate	CAPSULE;ORAL	207476-002	Dec 6, 2016	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for OMEPRAZOLE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	PRILOSEC	omeprazole	CAPSULE, DELAYED REL PELLETS;ORAL	019810-001	Sep 14, 1989	⤷ Sign Up	⤷ Sign Up
Astrazeneca	PRILOSEC	omeprazole	CAPSULE, DELAYED REL PELLETS;ORAL	019810-001	Sep 14, 1989	⤷ Sign Up	⤷ Sign Up
Astrazeneca	PRILOSEC	omeprazole	CAPSULE, DELAYED REL PELLETS;ORAL	019810-002	Jan 15, 1998	⤷ Sign Up	⤷ Sign Up
Astrazeneca	PRILOSEC	omeprazole	CAPSULE, DELAYED REL PELLETS;ORAL	019810-003	Oct 5, 1995	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for OMEPRAZOLE

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Country	Patent Number	Title	Estimated Expiration
Israel	147232	STABLE BENZIMIDAZOLE FORMULATION	⤷ Sign Up
Austria	390119		⤷ Sign Up
European Patent Office	3471708	COMPOSITIONS PHARMACEUTIQUES STABLES À DÉSINTÉGRATION ORALE (STABLE ORALLY DISINTEGRATING PHARMACEUTICAL COMPOSITIONS)	⤷ Sign Up
Spain	2304349		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for OMEPRAZOLE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1411900	SPC/GB11/015	United Kingdom	⤷ Sign Up	PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
0984957	2012/048	Ireland	⤷ Sign Up	PRODUCT NAME: A COMBINATION PRODUCT COMPRISING ASPIRIN AND ESOMEPRAZOLE MAGNESIUM TRIHYDRATE; NAT REGISTRATION NO/DATE: PA 970/063/001 20120831; FIRST REGISTRATION NO/DATE: 5402359; 5402367 5402375 20110812
1411900	2011C/016	Belgium	⤷ Sign Up	PRODUCT NAME: NAPROXENE ET ESOMEPRAZOLE (SOUS LA FORME D'ESOMEPRAZOLE MAGNESIUM TRIHYDRATE); AUTHORISATION NUMBER AND DATE: BE382505 20101214
1411900	2011/016	Ireland	⤷ Sign Up	PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE MODIFIED-RELEASE TABLETS; NAT REGISTRATION NO/DATE: PA0970/060/001 20101221; FIRST REGISTRATION NO/DATE: PL17901/0263-0001 20101105
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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