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Last Updated: August 11, 2020

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OMEPRAZOLE MAGNESIUM Drug Profile

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

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

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

US ANDA 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
Spero TherapeuticsPhase 1
Haining Health-Coming Biotech Co., Ltd.Phase 2
Radboud UniversityPhase 1

See all OMEPRAZOLE MAGNESIUM clinical trials

Paragraph IV (Patent) Challenges for OMEPRAZOLE MAGNESIUM
Tradename Dosage Ingredient NDA Submissiondate
PRILOSEC OTC TABLET, DELAYED RELEASE;ORAL omeprazole magnesium 021229 2012-03-30
PRILOSEC OTC TABLET, DELAYED RELEASE;ORAL omeprazole magnesium 021229 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
Dr Reddys Labs Ltd OMEPRAZOLE MAGNESIUM omeprazole magnesium CAPSULE, DELAYED RELEASE;ORAL 078878-001 Jun 5, 2009 OTC No Yes   Start Trial   Start Trial   Start Trial
Hetero Labs Ltd Iii OMEPRAZOLE MAGNESIUM omeprazole magnesium TABLET, DELAYED RELEASE;ORAL 211732-001 Mar 25, 2020 OTC No No   Start Trial   Start Trial   Start Trial
Spil OMEPRAZOLE MAGNESIUM omeprazole magnesium CAPSULE, DELAYED RELEASE;ORAL 210593-001 Jul 20, 2018 OTC No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd OMEPRAZOLE MAGNESIUM omeprazole magnesium TABLET, DELAYED RELEASE;ORAL 206877-001 Jun 6, 2018 OTC No No   Start Trial   Start Trial   Start Trial
>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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