Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

McKinsey
Cantor Fitzgerald
Cerilliant
Chubb
Cipla
Accenture
US Army
Julphar
Covington
Medtronic

Generated: February 25, 2018

DrugPatentWatch Database Preview

OMEPRAZOLE Drug Profile

« Back to Dashboard

Which patents cover Omeprazole, and when can generic versions of Omeprazole launch?

Omeprazole is a drug marketed by Actavis Labs Fl Inc, Apotex, Aurobindo Pharma Ltd, Breckenridge Pharm, Dr Reddys Labs Ltd, Glenmark Generics, Impax Labs, Kremers Urban Pharms, Lupin Ltd, Mylan, Sandoz, Teva Pharms Usa, Zydus Pharms Usa Inc, Dexcel Pharma, Gastroentero, Actavis Elizabeth, Ajanta Pharma Ltd, Aurolife Pharma Llc, Par Pharm, Perrigo R And D, and Sciegen Pharms Inc. and is included in thirty-one NDAs. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has nine patent family members in eight countries.

The generic ingredient in OMEPRAZOLE is omeprazole magnesium. There are one hundred and twenty-six drug master file entries for this compound. Twenty-three suppliers are listed for this compound. There are two tentative approvals for this compound. Additional details are available on the omeprazole magnesium profile page.
Drug patent expirations by year for OMEPRAZOLE
Pharmacology for OMEPRAZOLE

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
Dexcel Pharma OMEPRAZOLE omeprazole TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL 209400-001 Jul 5, 2017 OTC Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Sandoz OMEPRAZOLE omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 075757-001 Jan 28, 2003 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Dr Reddys Labs Ltd OMEPRAZOLE AND SODIUM BICARBONATE omeprazole; sodium bicarbonate CAPSULE;ORAL 204068-001 Jul 15, 2016 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Par Pharm OMEPRAZOLE AND SODIUM BICARBONATE omeprazole; sodium bicarbonate FOR SUSPENSION;ORAL 079182-002 Apr 19, 2013 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Ajanta Pharma Ltd OMEPRAZOLE AND SODIUM BICARBONATE omeprazole; sodium bicarbonate CAPSULE;ORAL 204228-002 Jul 15, 2016 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Dr Reddys Labs Ltd OMEPRAZOLE AND SODIUM BICARBONATE omeprazole; sodium bicarbonate CAPSULE;ORAL 204068-002 Jul 15, 2016 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Sciegen Pharms Inc OMEPRAZOLE AND SODIUM BICARBONATE omeprazole; sodium bicarbonate CAPSULE;ORAL 207476-001 Dec 6, 2016 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Dr Reddys Labs Ltd OMEPRAZOLE MAGNESIUM omeprazole magnesium CAPSULE, DELAYED RELEASE;ORAL 078878-001 Jun 5, 2009 OTC No Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Lupin Ltd OMEPRAZOLE omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 202384-001 Aug 25, 2015 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Sandoz OMEPRAZOLE omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 075757-002 Jan 28, 2003 AB RX No Yes ➤ 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

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

Paragraph IV (Patent) Challenges for OMEPRAZOLE
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Delayed-release Tablets 20 mg ➤ Subscribe 6/3/2015

Non-Orange Book US Patents for OMEPRAZOLE

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,255,878 Stable benzimidazole formulation ➤ Sign Up
Patent No. Title Estimated Patent Expiration

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

International Patents for OMEPRAZOLE

Supplementary Protection Certificates for OMEPRAZOLE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB11/015 United Kingdom ➤ Sign Up PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
C/GB11/013 United Kingdom ➤ Sign Up PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
11/016 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
12/048 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
C/GB01/006 United Kingdom ➤ Sign Up PRODUCT NAME: ESOMEPRAZOLE AS MAGNESIUM TRIHYDRATE; REGISTERED: SE 15945 20000310; SE 15946 20000310; UK PL 17901/0068-0069 20000727
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Citi
Daiichi Sankyo
Moodys
Fuji
QuintilesIMS
UBS
Dow
US Army

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

botpot