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Last Updated: March 19, 2024

Omeprazole - Generic Drug Details


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What are the generic drug sources for omeprazole and what is the scope of freedom to operate?

Omeprazole is the generic ingredient in eight branded drugs marketed by Actavis Labs Fl Inc, Apotex, Aurobindo Pharma, 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, 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 seven 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-four 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
AmgenEarly Phase 1
Boehringer IngelheimN/A
Aya Mohamed Sadek ElsaidPhase 3

See all omeprazole clinical trials

Generic filers with tentative approvals for OMEPRAZOLE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial40MGCAPSULE, DELAYED REL PELLETS;ORAL
⤷  Try a Trial⤷  Try a Trial20MGCAPSULE, DELAYED REL PELLETS;ORAL
⤷  Try a Trial⤷  Try a Trial10MGCAPSULE, 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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Ajanta Pharma Ltd OMEPRAZOLE AND SODIUM BICARBONATE omeprazole; sodium bicarbonate FOR SUSPENSION;ORAL 205545-002 Jul 27, 2016 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Salix ZEGERID omeprazole; sodium bicarbonate FOR SUSPENSION;ORAL 021636-002 Dec 21, 2004 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Teva Pharms Usa OMEPRAZOLE omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 204661-001 Jun 13, 2017 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca PRILOSEC omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 019810-003 Oct 5, 1995 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca PRILOSEC omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 019810-001 Sep 14, 1989 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca PRILOSEC omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 019810-002 Jan 15, 1998 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for omeprazole

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

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