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Last Updated: December 5, 2020

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OMEPRAZOLE Drug Profile

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Which patents cover Omeprazole, and what generic alternatives are available?

Omeprazole is a drug 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, Zydus Pharms Usa Inc, Dexcel Pharma, Dr Reddys, Sun Pharm, Cumberland Pharms, Ajanta Pharma Ltd, Aurolife Pharma Llc, Guardian Drug, Par Pharm, Perrigo R And D, Sciegen Pharms Inc, Unicorn, Zydus Pharms, Spil, and P And L. and is included in forty-three NDAs. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has twelve patent family members in eight countries.

The generic ingredient in OMEPRAZOLE is omeprazole magnesium. There are one hundred and thirty-one drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. Additional details are available on the omeprazole magnesium profile page.

US ANDA Litigation and Generic Entry Outlook for Omeprazole

A generic version of OMEPRAZOLE was approved as omeprazole magnesium by DR REDDYS LABS LTD on June 5th, 2009.

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Drug patent expirations by year for OMEPRAZOLE
Drug Prices for OMEPRAZOLE

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Drug Sales Revenue Trends for OMEPRAZOLE

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Recent Clinical Trials for OMEPRAZOLE

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SponsorPhase
King Chulalongkorn Memorial HospitalN/A
ViiV HealthcarePhase 1
Wake Forest University Health SciencesPhase 2

See all OMEPRAZOLE clinical trials

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
Par Pharm OMEPRAZOLE AND SODIUM BICARBONATE omeprazole; sodium bicarbonate FOR SUSPENSION;ORAL 079182-001 Apr 19, 2013 AB RX No No   Start Trial   Start Trial   Start Trial
Teva Pharms Usa OMEPRAZOLE omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 204661-002 Jun 13, 2017 DISCN No No   Start Trial   Start Trial   Start Trial
Mylan OMEPRAZOLE omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 205070-001 Jun 29, 2018 DISCN No No   Start Trial   Start Trial   Start Trial
Dexcel Pharma OMEPRAZOLE omeprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 209400-001 Jul 5, 2017 OTC Yes No   Start Trial   Start Trial Y   Start Trial
Par Pharm OMEPRAZOLE AND SODIUM BICARBONATE omeprazole; sodium bicarbonate CAPSULE;ORAL 078966-001 May 25, 2010 DISCN No No   Start Trial   Start Trial   Start Trial
Apotex OMEPRAZOLE omeprazole TABLET, DELAYED RELEASE;ORAL 210070-001 Feb 11, 2019 DISCN No No   Start Trial   Start Trial   Start Trial
Cumberland Pharms OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN amoxicillin; clarithromycin; omeprazole CAPSULE, TABLET, CAPSULE, DELAYED RELEASE;ORAL 050824-001 Feb 8, 2011 RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for OMEPRAZOLE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0984957 SPC/GB11/013 United Kingdom   Start Trial PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
1411900 SPC/GB11/015 United Kingdom   Start Trial PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
1411900 2011/016 Ireland   Start 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
0124495 SPC/GB01/006 United Kingdom   Start Trial PRODUCT NAME: ESOMEPRAZOLE AS MAGNESIUM TRIHYDRATE; REGISTERED: SE 15945 20000310; SE 15946 20000310; UK PL 17901/0068-0069 20000727
0984957 2012/048 Ireland   Start 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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