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Last Updated: March 29, 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
Dr Reddys Labs Ltd OMEPRAZOLE omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 078490-002 Mar 16, 2009 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan OMEPRAZOLE omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 205070-003 Jun 29, 2018 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Glenmark Generics OMEPRAZOLE omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 091672-001 Oct 31, 2014 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 019810-001 Sep 14, 1989 ⤷  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
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
1411900 2011C/016 Belgium ⤷  Try a Trial PRODUCT NAME: NAPROXENE ET ESOMEPRAZOLE (SOUS LA FORME D'ESOMEPRAZOLE MAGNESIUM TRIHYDRATE); AUTHORISATION NUMBER AND DATE: BE382505 20101214
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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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 verification 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.