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Last Updated: July 23, 2024

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 eight branded drugs marketed by Actavis Labs Fl Inc, Apotex, Aurobindo Pharma, Breckenridge, Dr Reddys Labs Ltd, Glenmark Pharms Ltd, Hetero Labs Ltd Iii, Impax Labs, Lannett Co Inc, Lupin Ltd, Mylan, Sandoz, Strides Pharma, Teva Pharms Usa, Xiromed, Zydus Pharms Usa Inc, Astrazeneca, Dexcel Pharma, Dr Reddys, Sun Pharm, Dexcel, Aurobindo Pharma Ltd, L Perrigo Co, Spil, Covis, P And L, Perrigo R And D, Ajanta Pharma Ltd, Anda Repository, Aurolife Pharma Llc, Chartwell Rx, Sciegen Pharms Inc, Zydus, Zydus Pharms, Salix, Riley Consumer, and Azurity, and is included in fifty-three NDAs. There are eight patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Omeprazole has thirteen patent family members in eight countries.

There are one hundred and thirty-one drug master file entries for omeprazole. Ninety-six 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
Hospital Clinico Universitario de SantiagoPhase 4
Complejo Hospitalario de NavarraPhase 4
San Raffaele University Hospital, ItalyPhase 4

See all omeprazole clinical trials

Generic filers with 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

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 Strength NDA ANDAs Submitted Submissiondate
OMEPRAZOLE Delayed-release Tablets omeprazole 20 mg 022032 1 2015-06-03

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
Aurobindo Pharma OMEPRAZOLE MAGNESIUM omeprazole magnesium TABLET, DELAYED RELEASE;ORAL 206877-001 Jun 6, 2018 OTC No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Glenmark Pharms Ltd OMEPRAZOLE omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 091672-003 Oct 31, 2014 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Spil OMEPRAZOLE MAGNESIUM omeprazole magnesium CAPSULE, DELAYED RELEASE;ORAL 210593-001 Jul 20, 2018 OTC No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Teva Pharms Usa OMEPRAZOLE omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 204661-002 Jun 13, 2017 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Azurity KONVOMEP omeprazole; sodium bicarbonate FOR SUSPENSION;ORAL 213593-001 Aug 30, 2022 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Covis PRILOSEC omeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 022056-002 Mar 20, 2008 RX Yes 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

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 019810-002 Jan 15, 1998 ⤷  Sign Up ⤷  Sign Up
Astrazeneca PRILOSEC omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 019810-002 Jan 15, 1998 ⤷  Sign Up ⤷  Sign Up
Astrazeneca PRILOSEC omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 019810-003 Oct 5, 1995 ⤷  Sign Up ⤷  Sign Up
Astrazeneca PRILOSEC omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 019810-001 Sep 14, 1989 ⤷  Sign Up ⤷  Sign Up
Astrazeneca PRILOSEC omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 019810-001 Sep 14, 1989 ⤷  Sign Up ⤷  Sign Up
Astrazeneca 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

International Patents for omeprazole

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 2017216789 ⤷  Sign Up
Spain 2304349 ⤷  Sign Up
Germany 60038447 ⤷  Sign Up
Australia 2017285390 Stable orally disintegrating pharmaceutical compositions ⤷  Sign Up
European Patent Office 3471708 COMPOSITIONS PHARMACEUTIQUES STABLES À DÉSINTÉGRATION ORALE (STABLE ORALLY DISINTEGRATING PHARMACEUTICAL COMPOSITIONS) ⤷  Sign Up
European Patent Office 1187599 FORMULATION DE BENZIMIDAZOLE STABLE (STABLE BENZIMIDAZOLE FORMULATION) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for omeprazole

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0984957 SPC/GB11/013 United Kingdom ⤷  Sign Up PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
1411900 2011C/016 Belgium ⤷  Sign Up PRODUCT NAME: NAPROXENE ET ESOMEPRAZOLE (SOUS LA FORME D'ESOMEPRAZOLE MAGNESIUM TRIHYDRATE); AUTHORISATION NUMBER AND DATE: BE382505 20101214
0124495 SPC/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
1411900 SPC/GB11/015 United Kingdom ⤷  Sign Up PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
0984957 2012/048 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
1411900 2011/016 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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