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Last Updated: August 9, 2020

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Omeprazole magnesium - Generic Drug Details

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

Omeprazole magnesium is the generic ingredient in three branded drugs marketed by Dr Reddys Labs Ltd, Spil, Covis Pharma Bv, Aurobindo Pharma Ltd, Hetero Labs Ltd Iii, P And L, Perrigo R And D, and Astrazeneca Pharms, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

There are one hundred and thirty-one drug master file entries for omeprazole magnesium. Thirty-six suppliers are listed for this compound.

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

Pharmacology for omeprazole magnesium
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
Spil OMEPRAZOLE MAGNESIUM omeprazole magnesium CAPSULE, DELAYED RELEASE;ORAL 210593-001 Jul 20, 2018 OTC No No   Start Trial   Start Trial   Start Trial
Covis Pharma Bv PRILOSEC omeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 022056-002 Mar 20, 2008 RX Yes 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
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
Astrazeneca Pharms PRILOSEC OTC omeprazole magnesium TABLET, DELAYED RELEASE;ORAL 021229-001 Jun 20, 2003 OTC Yes Yes   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

Expired US Patents for omeprazole magnesium

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Pharms PRILOSEC OTC omeprazole magnesium TABLET, DELAYED RELEASE;ORAL 021229-001 Jun 20, 2003   Start Trial   Start Trial
Astrazeneca Pharms PRILOSEC OTC omeprazole magnesium TABLET, DELAYED RELEASE;ORAL 021229-001 Jun 20, 2003   Start Trial   Start Trial
Covis Pharma Bv PRILOSEC omeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 022056-002 Mar 20, 2008   Start Trial   Start Trial
Covis Pharma Bv PRILOSEC omeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 022056-001 Mar 20, 2008   Start Trial   Start Trial
Astrazeneca Pharms PRILOSEC OTC omeprazole magnesium TABLET, DELAYED RELEASE;ORAL 021229-001 Jun 20, 2003   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Moodys
Johnson and Johnson
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Boehringer Ingelheim
Express Scripts

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