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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
UBS
Johnson and Johnson
Fuji
Farmers Insurance
US Army
McKesson
Dow
Covington
Cerilliant

Generated: February 21, 2018

DrugPatentWatch Database Preview

Omeprazole - Generic Drug Details

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

Omeprazole
is the generic ingredient in seven branded drugs 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, Astrazeneca Pharms, Dexcel Pharma, Covis Pharma Bv, Perrigo R And D, Actavis Elizabeth, Ajanta Pharma Ltd, Aurolife Pharma Llc, Par Pharm, Sciegen Pharms Inc, Santarus Inc, and Bayer Healthcare Llc, and is included in thirty-seven NDAs. There are seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Omeprazole has thirty-four patent family members in seventeen countries.

There are one hundred and twenty-six drug master file entries for omeprazole. One hundred and ten suppliers are listed for this compound. There are two tentative approvals for this compound.
Pharmacology for omeprazole
Medical Subject Heading (MeSH) Categories for omeprazole
Tentative approvals for OMEPRAZOLE
Applicant Application No. Strength Dosage Form
➤ Sign Up➤ Sign Up10MGCAPSULE, DELAYED REL PELLETS;ORAL
➤ Sign Up➤ Sign Up40MGCAPSULE, DELAYED REL PELLETS;ORAL
➤ Sign Up➤ Sign Up20MGCAPSULE, DELAYED REL PELLETS;ORAL

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
Perrigo R And D OMEPRAZOLE MAGNESIUM omeprazole magnesium TABLET, DELAYED RELEASE;ORAL 204152-001 Jul 30, 2015 OTC No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Astrazeneca Pharms PRILOSEC omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 019810-003 Oct 5, 1995 DISCN Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Astrazeneca Pharms PRILOSEC omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 019810-001 Sep 14, 1989 DISCN Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Aurolife Pharma Llc OMEPRAZOLE AND SODIUM BICARBONATE omeprazole; sodium bicarbonate CAPSULE;ORAL 204922-001 Aug 19, 2016 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Zydus Pharms Usa Inc OMEPRAZOLE omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 091352-003 Nov 19, 2012 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Dr Reddys Labs Ltd OMEPRAZOLE omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 078490-001 Apr 17, 2009 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
Perrigo R And D OMEPRAZOLE AND SODIUM BICARBONATE omeprazole; sodium bicarbonate CAPSULE;ORAL 201361-001 Jul 15, 2016 OTC 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
Kremers Urban Pharms OMEPRAZOLE omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 075410-003 Jan 23, 2009 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

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Expired US Patents for omeprazole

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

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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

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International Patents for omeprazole

Supplementary Protection Certificates for omeprazole

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB11/013 United Kingdom ➤ Sign Up PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
C/GB11/015 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

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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
Cipla
Chinese Patent Office
Baxter
QuintilesIMS
Federal Trade Commission
Julphar
Medtronic
Covington

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.

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