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Last Updated: October 26, 2021

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Omeprazole - Generic Drug Details

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What are the generic drug sources for omeprazole and what is the scope of patent protection?

Omeprazole is the generic ingredient in seven branded drugs marketed by Actavis Labs Fl Inc, Apotex, Aurobindo Pharma Ltd, Breckenridge, Dr Reddys Labs Ltd, Glenmark Generics, Hetero Labs Ltd Iii, Impax Labs, Lannett Co Inc, Lupin Ltd, Mylan, Sandoz, Teva Pharms Usa, Xiromed, Zydus Pharms Usa Inc, Astrazeneca, Dexcel Pharma, Dr Reddys, Sun Pharm, Spil, Covis, P And L, Perrigo R And D, Ajanta Pharma Ltd, Aurolife Pharma Llc, Guardian Drug, Par Pharm, Sciegen Pharms Inc, Unicorn, Zydus Pharms, Salix, and Bayer Healthcare Llc, and is included in fifty NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Omeprazole has twelve patent family members in eight countries.

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

Drug Prices for omeprazole

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Drug Sales Revenue Trends for omeprazole

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Recent Clinical Trials for omeprazole

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

SponsorPhase
Dow University of Health SciencesPhase 4
ParexelPhase 1
University of OklahomaEarly Phase 1

See all omeprazole clinical trials

Generic filers with tentative approvals for OMEPRAZOLE
Applicant Application No. Strength Dosage Form
⤷  Free Forever Trial⤷  Free Forever Trial40MGCAPSULE, DELAYED REL PELLETS;ORAL
⤷  Free Forever Trial⤷  Free Forever Trial20MGCAPSULE, DELAYED REL PELLETS;ORAL
⤷  Free Forever Trial⤷  Free Forever Trial10MGCAPSULE, 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
Medical Subject Heading (MeSH) Categories for omeprazole
Paragraph IV (Patent) Challenges for OMEPRAZOLE
Tradename Dosage Ingredient NDA Submissiondate
PRILOSEC CAPSULE, DELAYED REL PELLETS;ORAL omeprazole 019810
OMEPRAZOLE TABLET, DELAYED RELEASE;ORAL omeprazole 022032

US Patents and Regulatory Information for omeprazole

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan OMEPRAZOLE omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 075876-001 May 29, 2003 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Zydus Pharms OMEPRAZOLE AND SODIUM BICARBONATE omeprazole; sodium bicarbonate CAPSULE;ORAL 203290-002 May 25, 2018 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Par Pharm OMEPRAZOLE AND SODIUM BICARBONATE omeprazole; sodium bicarbonate FOR SUSPENSION;ORAL 079182-001 Apr 19, 2013 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
>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

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 ⤷  Free Forever Trial ⤷  Free Forever Trial
Astrazeneca PRILOSEC omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 019810-002 Jan 15, 1998 ⤷  Free Forever Trial ⤷  Free Forever Trial
Astrazeneca PRILOSEC omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 019810-002 Jan 15, 1998 ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for omeprazole

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1411900 2011/016 Ireland ⤷  Free Forever Trial PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE MODIFIED-RELEASE TABLETS; NAT REGISTRATION NO/DATE: PA0970/060/001 20101221; FIRST REGISTRATION NO/DATE: PL17901/0263-0001 20101105
0984957 2012/048 Ireland ⤷  Free Forever Trial 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 SPC/GB11/015 United Kingdom ⤷  Free Forever Trial PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Merck
Express Scripts
Moodys
Colorcon
Dow
Harvard Business School

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