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PRILOSEC OTC Drug Profile

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Which patents cover Prilosec Otc, and what generic alternatives are available?

Prilosec Otc is a drug marketed by Astrazeneca Pharms and is included in one NDA.

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

US ANDA Litigation and Generic Entry Outlook for Prilosec Otc

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

Summary for PRILOSEC OTC

US Patents:	0
Applicants:	1
NDAs:	1
Suppliers / Packagers:	2
Bulk Api Vendors:	160
Clinical Trials:	22
Patent Applications:	4,158
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for PRILOSEC OTC
Drug Sales Revenues:	Drug sales revenues for PRILOSEC OTC
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PRILOSEC OTC
DailyMed Link:	PRILOSEC OTC at DailyMed

See drug prices for PRILOSEC OTC

See drug sales revenues for PRILOSEC OTC

Recent Clinical Trials for PRILOSEC OTC

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

Sponsor	Phase
Corcept Therapeutics	Phase 1
The University of Texas Health Science Center at San Antonio	Phase 0
AstraZeneca	Phase 1

See all PRILOSEC OTC clinical trials

Paragraph IV (Patent) Challenges for PRILOSEC OTC

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 PRILOSEC OTC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astrazeneca Pharms	PRILOSEC OTC	omeprazole magnesium	TABLET, DELAYED RELEASE;ORAL	021229-001	Jun 20, 2003		OTC	Yes	Yes

Expired US Patents for PRILOSEC OTC

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
Astrazeneca Pharms	PRILOSEC OTC	omeprazole magnesium	TABLET, DELAYED RELEASE;ORAL	021229-001	Jun 20, 2003
Astrazeneca Pharms	PRILOSEC OTC	omeprazole magnesium	TABLET, DELAYED RELEASE;ORAL	021229-001	Jun 20, 2003
Astrazeneca Pharms	PRILOSEC OTC	omeprazole magnesium	TABLET, DELAYED RELEASE;ORAL	021229-001	Jun 20, 2003
Astrazeneca Pharms	PRILOSEC OTC	omeprazole magnesium	TABLET, DELAYED RELEASE;ORAL	021229-001	Jun 20, 2003
Astrazeneca Pharms	PRILOSEC OTC	omeprazole magnesium	TABLET, DELAYED RELEASE;ORAL	021229-001	Jun 20, 2003

International Patents for PRILOSEC OTC

Country	Patent Number	Estimated Expiration
Latvia	5503
Germany	10199022
Sweden	9803952
Austria	140387
Turkey	9500826
Hungary	T75775

Supplementary Protection Certificates for PRILOSEC OTC

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1411900	2011/016	Ireland		PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE MODIFIED-RELEASE TABLETS; NAT REGISTRATION NO/DATE: PA0970/060/001 20101221; FIRST REGISTRATION NO/DATE: PL17901/0263-0001 20101105
1411900	SPC/GB11/015	United Kingdom		PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
0124495	SPC/GB01/006	United Kingdom		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		PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
0984957	2012/048	Ireland		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