OMEPRAZOLE MAGNESIUM - Generic Drug Details

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What are the generic sources for omeprazole magnesium and what is the scope of patent protection?

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

There are seventy-three drug master file entries for omeprazole magnesium. Fifty suppliers are listed for this compound.

Summary for OMEPRAZOLE MAGNESIUM

US Patents:	0
Tradenames:	3
Applicants:	10
NDAs:	10
Drug Master File Entries:	73
Finished Product Suppliers / Packagers:	50
Raw Ingredient (Bulk) Api Vendors:	294
Clinical Trials:	14
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for OMEPRAZOLE MAGNESIUM
What excipients (inactive ingredients) are in OMEPRAZOLE MAGNESIUM?	OMEPRAZOLE MAGNESIUM excipients list
DailyMed Link:	OMEPRAZOLE MAGNESIUM at DailyMed

Recent Clinical Trials for OMEPRAZOLE MAGNESIUM

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

Sponsor	Phase
Amgen	Early Phase 1
AnHeart Therapeutics Inc.	Phase 1
Instituto Mexicano del Seguro Social	Phase 4

See all OMEPRAZOLE MAGNESIUM clinical trials

Pharmacology for OMEPRAZOLE MAGNESIUM

Drug Class	Proton Pump Inhibitor
Mechanism of Action	Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for OMEPRAZOLE MAGNESIUM

A02BC	Proton pump inhibitors
A02B	DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
A02	DRUGS FOR ACID RELATED DISORDERS
A	Alimentary tract and metabolism

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
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
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
Covis	PRILOSEC	omeprazole magnesium	FOR SUSPENSION, DELAYED RELEASE;ORAL	022056-002	Mar 20, 2008		RX	Yes	Yes	⤷ 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

Expired US Patents for OMEPRAZOLE MAGNESIUM

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

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