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Last Updated: January 18, 2021

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PRILOSEC Drug Profile

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

Prilosec is a drug marketed by Astrazeneca Pharms and Covis Pharma Bv 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. Thirty-seven 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

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

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Drug patent expirations by year for PRILOSEC
Drug Prices for PRILOSEC

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Drug Sales Revenue Trends for PRILOSEC

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Recent Clinical Trials for PRILOSEC

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

SponsorPhase
Corcept TherapeuticsPhase 1
The University of Texas Health Science Center at San AntonioPhase 0
AstraZenecaPhase 1

See all PRILOSEC clinical trials

Pharmacology for PRILOSEC
Paragraph IV (Patent) Challenges for PRILOSEC
Tradename Dosage Ingredient NDA Submissiondate
PRILOSEC CAPSULE, DELAYED REL PELLETS;ORAL omeprazole 019810

US Patents and Regulatory Information for PRILOSEC

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 omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 019810-003 Oct 5, 1995 DISCN Yes No   Start Trial   Start Trial   Start Trial
Covis Pharma Bv PRILOSEC omeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 022056-001 Mar 20, 2008 RX Yes No   Start Trial   Start Trial   Start Trial
Astrazeneca Pharms PRILOSEC omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 019810-001 Sep 14, 1989 DISCN Yes No   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 PRILOSEC

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca Pharms PRILOSEC omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 019810-002 Jan 15, 1998   Start Trial   Start Trial
Astrazeneca Pharms PRILOSEC omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 019810-003 Oct 5, 1995   Start Trial   Start Trial
Astrazeneca Pharms PRILOSEC omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 019810-003 Oct 5, 1995   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for PRILOSEC

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1411900 2011/016 Ireland   Start 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
1411900 SPC/GB11/015 United Kingdom   Start Trial PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
0005129 SPC/GB99/015 United Kingdom   Start Trial SPC/GB99/015, EXPIRES: 20021115
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Merck

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