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Last Updated: August 11, 2022

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

This drug has thirteen 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. Forty-two suppliers are listed for this compound. Additional details are available on the omeprazole magnesium profile page.

DrugPatentWatch® 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

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

SponsorPhase
NorthSea Therapeutics B.V.Phase 1
Instituto Mexicano del Seguro SocialPhase 4
Oregon Health and Science UniversityPhase 2

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Pharmacology for OMEPRAZOLE
Medical Subject Heading (MeSH) Categories for OMEPRAZOLE
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

OMEPRAZOLE is protected by three US patents.

Patents protecting OMEPRAZOLE

Stable orally disintegrating pharmaceutical compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Stable orally disintegrating pharmaceutical compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Stable benzimidazole formulation
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Zydus Pharms OMEPRAZOLE AND SODIUM BICARBONATE omeprazole; sodium bicarbonate CAPSULE;ORAL 203290-002 May 25, 2018 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Teva Pharms Usa OMEPRAZOLE omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 204661-002 Jun 13, 2017 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Mylan OMEPRAZOLE omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 205070-002 Jun 29, 2018 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Dr Reddys OMEPRAZOLE omeprazole TABLET, DELAYED RELEASE;ORAL 207740-001 Nov 5, 2018 OTC No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Dr Reddys OMEPRAZOLE AND SODIUM BICARBONATE omeprazole; sodium bicarbonate CAPSULE;ORAL 204068-002 Jul 15, 2016 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for OMEPRAZOLE

See the table below for patents covering OMEPRAZOLE around the world.

Country Patent Number Title Estimated Expiration
Germany 60038447 See Plans and Pricing
European Patent Office 1187599 FORMULATION DE BENZIMIDAZOLE STABLE (STABLE BENZIMIDAZOLE FORMULATION) See Plans and Pricing
Spain 2304349 See Plans and Pricing
World Intellectual Property Organization (WIPO) 2017216789 See Plans and Pricing
Australia 5423200 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for OMEPRAZOLE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0984957 2012/048 Ireland See Plans and Pricing 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 2011/016 Ireland See Plans and Pricing PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE MODIFIED-RELEASE TABLETS; NAT REGISTRATION NO/DATE: PA0970/060/001 20101221; FIRST REGISTRATION NO/DATE: PL17901/0263-0001 20101105
1411900 SPC/GB11/015 United Kingdom See Plans and Pricing PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
1411900 2011C/016 Belgium See Plans and Pricing PRODUCT NAME: NAPROXENE ET ESOMEPRAZOLE (SOUS LA FORME D'ESOMEPRAZOLE MAGNESIUM TRIHYDRATE); AUTHORISATION NUMBER AND DATE: BE382505 20101214
0124495 SPC/GB01/006 United Kingdom See Plans and Pricing PRODUCT NAME: ESOMEPRAZOLE AS MAGNESIUM TRIHYDRATE; REGISTERED: SE 15945 20000310; SE 15946 20000310; UK PL 17901/0068-0069 20000727
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Merck
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Moodys

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