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Last Updated: November 4, 2024

OMEPRAZOLE MAGNESIUM Drug Patent Profile


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Which patents cover Omeprazole Magnesium, and what generic alternatives are available?

Omeprazole Magnesium is a drug marketed by Aurobindo Pharma Ltd, Dr Reddys Labs Ltd, L Perrigo Co, Spil, Aurobindo Pharma, Hetero Labs Ltd Iii, P And L, and Perrigo R And D. and is included in eight NDAs.

The generic ingredient in OMEPRAZOLE MAGNESIUM is omeprazole magnesium. There are one hundred and thirty-one drug master file entries for this compound. Fifty-one suppliers are listed for this compound. Additional details are available on the omeprazole magnesium profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Omeprazole Magnesium

A generic version of OMEPRAZOLE MAGNESIUM was approved as omeprazole magnesium by DR REDDYS LABS LTD on June 5th, 2009.

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Drug patent expirations by year for OMEPRAZOLE MAGNESIUM
Recent Clinical Trials for OMEPRAZOLE MAGNESIUM

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
AmgenEarly Phase 1
AnHeart Therapeutics Inc.Phase 1
Instituto Mexicano del Seguro SocialPhase 4

See all OMEPRAZOLE MAGNESIUM clinical trials

Pharmacology for OMEPRAZOLE MAGNESIUM
Paragraph IV (Patent) Challenges for OMEPRAZOLE MAGNESIUM
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
PRILOSEC OTC Delayed-release Tablets omeprazole magnesium 20 mg 021229 1 2012-03-30
PRILOSEC OTC Delayed-release Capsules omeprazole magnesium 20 mg 021229 1 2007-03-19

US Patents and Regulatory Information for OMEPRAZOLE MAGNESIUM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aurobindo Pharma Ltd OMEPRAZOLE MAGNESIUM omeprazole magnesium CAPSULE, DELAYED RELEASE;ORAL 213201-001 Apr 28, 2023 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
P And L OMEPRAZOLE MAGNESIUM omeprazole magnesium TABLET, DELAYED RELEASE;ORAL 206582-001 Jun 1, 2020 OTC 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
Perrigo R And D OMEPRAZOLE MAGNESIUM omeprazole magnesium TABLET, DELAYED RELEASE;ORAL 204152-001 Jul 30, 2015 DISCN 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
L Perrigo Co OMEPRAZOLE MAGNESIUM omeprazole magnesium CAPSULE, DELAYED RELEASE;ORAL 216096-001 May 24, 2022 OTC No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hetero Labs Ltd Iii OMEPRAZOLE MAGNESIUM omeprazole magnesium TABLET, DELAYED RELEASE;ORAL 211732-001 Mar 25, 2020 OTC 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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