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Serving leading biopharmaceutical companies globally:

Citi
Accenture
Medtronic
US Army
Harvard Business School
QuintilesIMS
Argus Health
Merck
US Department of Justice
Daiichi Sankyo

Generated: January 22, 2018

DrugPatentWatch Database Preview

PRILOSEC OTC Drug Profile

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

Prilosec Otc is a drug marketed by Astrazeneca Pharms and is included in one NDA. There are two patents protecting this drug and two Paragraph IV challenges.

This drug has forty-eight patent family members in nineteen countries.

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

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 ➤ Subscribe ➤ Subscribe ➤ Subscribe
Astrazeneca Pharms PRILOSEC OTC omeprazole magnesium TABLET, DELAYED RELEASE;ORAL 021229-001 Jun 20, 2003 OTC Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
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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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 ➤ Subscribe ➤ Subscribe
Astrazeneca Pharms PRILOSEC OTC omeprazole magnesium TABLET, DELAYED RELEASE;ORAL 021229-001 Jun 20, 2003 ➤ Subscribe ➤ Subscribe
Astrazeneca Pharms PRILOSEC OTC omeprazole magnesium TABLET, DELAYED RELEASE;ORAL 021229-001 Jun 20, 2003 ➤ Subscribe ➤ Subscribe
Astrazeneca Pharms PRILOSEC OTC omeprazole magnesium TABLET, DELAYED RELEASE;ORAL 021229-001 Jun 20, 2003 ➤ Subscribe ➤ Subscribe
Astrazeneca Pharms PRILOSEC OTC omeprazole magnesium TABLET, DELAYED RELEASE;ORAL 021229-001 Jun 20, 2003 ➤ Subscribe ➤ Subscribe
Astrazeneca Pharms PRILOSEC OTC omeprazole magnesium TABLET, DELAYED RELEASE;ORAL 021229-001 Jun 20, 2003 ➤ Subscribe ➤ Subscribe
Astrazeneca Pharms PRILOSEC OTC omeprazole magnesium TABLET, DELAYED RELEASE;ORAL 021229-001 Jun 20, 2003 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for PRILOSEC OTC
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Delayed-release Tablets 20 mg ➤ Subscribe 3/30/2012
➤ Subscribe Delayed-release Capsules 20 mg ➤ Subscribe 3/19/2007

International Patents for PRILOSEC OTC

Supplementary Protection Certificates for PRILOSEC OTC

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
12/048 Ireland ➤ Subscribe 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
C/GB11/015 United Kingdom ➤ Subscribe PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
C/GB11/013 United Kingdom ➤ Subscribe PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
C/GB01/006 United Kingdom ➤ Subscribe PRODUCT NAME: ESOMEPRAZOLE AS MAGNESIUM TRIHYDRATE; REGISTERED: SE 15945 20000310; SE 15946 20000310; UK PL 17901/0068-0069 20000727
11/016 Ireland ➤ Subscribe PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE MODIFIED-RELEASE TABLETS; NAT REGISTRATION NO/DATE: PA0970/060/001 20101221; FIRST REGISTRATION NO/DATE: PL17901/0263-0001 20101105
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Citi
Julphar
Covington
QuintilesIMS
Queensland Health
Deloitte
Fish and Richardson
Cantor Fitzgerald
Express Scripts

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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