PRILOSEC Drug Patent Profile

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When do Prilosec patents expire, and what generic alternatives are available?

Prilosec is a drug marketed by Astrazeneca and Covis and is included in three NDAs.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Prilosec

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

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Summary for PRILOSEC

US Patents:	0
Applicants:	2
NDAs:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	225
Clinical Trials:	50
Patent Applications:	4,181
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for PRILOSEC
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PRILOSEC
What excipients (inactive ingredients) are in PRILOSEC?	PRILOSEC excipients list
DailyMed Link:	PRILOSEC at DailyMed

Drug patent expirations by year for PRILOSEC

Recent Clinical Trials for PRILOSEC

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

Sponsor	Phase
Carlos Roberto Simons-Linares	Phase 4
Emory University	Phase 4
Alexion Pharmaceuticals	Phase 1

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Pharmacology for PRILOSEC

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

Anatomical Therapeutic Chemical (ATC) Classes for PRILOSEC

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

US Patents and Regulatory Information for PRILOSEC

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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
Astrazeneca	PRILOSEC	omeprazole	CAPSULE, DELAYED REL PELLETS;ORAL	019810-003	Oct 5, 1995		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Covis	PRILOSEC	omeprazole magnesium	FOR SUSPENSION, DELAYED RELEASE;ORAL	022056-001	Mar 20, 2008		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Astrazeneca	PRILOSEC	omeprazole	CAPSULE, DELAYED REL PELLETS;ORAL	019810-001	Sep 14, 1989		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Astrazeneca	PRILOSEC	omeprazole	CAPSULE, DELAYED REL PELLETS;ORAL	019810-002	Jan 15, 1998		DISCN	Yes	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 PRILOSEC

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	PRILOSEC	omeprazole	CAPSULE, DELAYED REL PELLETS;ORAL	019810-002	Jan 15, 1998	⤷ Try a Trial	⤷ Try a Trial
Covis	PRILOSEC	omeprazole magnesium	FOR SUSPENSION, DELAYED RELEASE;ORAL	022056-001	Mar 20, 2008	⤷ Try a Trial	⤷ Try a Trial
Astrazeneca	PRILOSEC	omeprazole	CAPSULE, DELAYED REL PELLETS;ORAL	019810-003	Oct 5, 1995	⤷ Try a Trial	⤷ Try a Trial
Astrazeneca	PRILOSEC	omeprazole	CAPSULE, DELAYED REL PELLETS;ORAL	019810-003	Oct 5, 1995	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for PRILOSEC

See the table below for patents covering PRILOSEC around the world.

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Country	Patent Number	Title	Estimated Expiration
Australia	529654		⤷ Try a Trial
European Patent Office	1104417	PROCEDE AMELIORE DE PREPARATION, D'ISOLATION ET DE PURIFICATION DE L'OMEPRAZOLE ET COMPOSITIONS D'OMEPRAZOLE (IMPROVED OMEPRAZOLE PROCESS AND COMPOSITIONS THEREOF)	⤷ Try a Trial
New Zealand	268694	COMPOSITION OF MAGNESIUM OMEPRAZOLE HAVING A CRYSTALLINITY GREATER THAN 70% HAVING AT LEAST ONE SUBCOATING AND AT LEAST ONE ENTERIC COATING	⤷ Try a Trial
Japan	S58192880	NOVEL BENZIMIDAZOLE COMPOUND	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for PRILOSEC

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0984957	2012/048	Ireland	⤷ Try a Trial	PRODUCT NAME: A COMBINATION PRODUCT COMPRISING ASPIRIN AND ESOMEPRAZOLE MAGNESIUM TRIHYDRATE; NAT REGISTRATION NO/DATE: PA 970/063/001 20120831; FIRST REGISTRATION NO/DATE: 5402359; 5402367 5402375 20110812
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
0984957	SPC/GB11/013	United Kingdom	⤷ Try a Trial	PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
1411900	2011/016	Ireland	⤷ Try a Trial	PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE MODIFIED-RELEASE TABLETS; NAT REGISTRATION NO/DATE: PA0970/060/001 20101221; FIRST REGISTRATION NO/DATE: PL17901/0263-0001 20101105
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

Summary for PRILOSEC

Recent Clinical Trials for PRILOSEC

Pharmacology for PRILOSEC

Anatomical Therapeutic Chemical (ATC) Classes for PRILOSEC

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