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Last Updated: May 19, 2022

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-two 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 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
Emory UniversityPhase 4
Alexion PharmaceuticalsPhase 1
Achillion, a wholly owned subsidiary of AlexionPhase 1

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Pharmacology for PRILOSEC

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 PRILOSEC omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 019810-003 Oct 5, 1995 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Covis PRILOSEC omeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 022056-001 Mar 20, 2008 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Astrazeneca PRILOSEC omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 019810-001 Sep 14, 1989 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Astrazeneca PRILOSEC omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 019810-002 Jan 15, 1998 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Astrazeneca PRILOSEC OTC omeprazole magnesium TABLET, DELAYED RELEASE;ORAL 021229-001 Jun 20, 2003 OTC Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Covis PRILOSEC omeprazole magnesium FOR SUSPENSION, DELAYED RELEASE;ORAL 022056-002 Mar 20, 2008 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 PRILOSEC omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 019810-003 Oct 5, 1995 See Plans and Pricing See Plans and Pricing
Astrazeneca PRILOSEC omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 019810-001 Sep 14, 1989 See Plans and Pricing See Plans and Pricing
Astrazeneca PRILOSEC omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 019810-002 Jan 15, 1998 See Plans and Pricing See Plans and Pricing
Astrazeneca PRILOSEC omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 019810-001 Sep 14, 1989 See Plans and Pricing See Plans and Pricing
Astrazeneca PRILOSEC omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 019810-002 Jan 15, 1998 See Plans and Pricing See Plans and Pricing
Astrazeneca PRILOSEC omeprazole CAPSULE, DELAYED REL PELLETS;ORAL 019810-003 Oct 5, 1995 See Plans and Pricing See Plans and Pricing
>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.

Country Patent Number Title Estimated Expiration
Lithuania 2275 See Plans and Pricing
European Patent Office 1124539 FORMULATION PHARMACEUTIQUE CONTENANT DE L'OMEPRAZOLE (PHARMACEUTICAL FORMULATION COMPRISING OMEPRAZOLE) See Plans and Pricing
Yugoslavia 43794 See Plans and Pricing
Iceland 3221 See Plans and Pricing
Slovenia 0706378 See Plans and Pricing
European Patent Office 1240159 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for PRILOSEC

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1411900 2011/016 Ireland See Plans and Pricing PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE MODIFIED-RELEASE TABLETS; NAT REGISTRATION NO/DATE: PA0970/060/001 20101221; FIRST REGISTRATION NO/DATE: PL17901/0263-0001 20101105
0984957 SPC/GB11/013 United Kingdom See Plans and Pricing PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
0124495 SPC/GB01/006 United Kingdom See Plans and Pricing PRODUCT NAME: ESOMEPRAZOLE AS MAGNESIUM TRIHYDRATE; REGISTERED: SE 15945 20000310; SE 15946 20000310; UK PL 17901/0068-0069 20000727
1411900 SPC/GB11/015 United Kingdom See Plans and Pricing PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
0005129 SPC/GB99/015 United Kingdom See Plans and Pricing SPC/GB99/015, EXPIRES: 20021115
1411900 2011C/016 Belgium See Plans and Pricing PRODUCT NAME: NAPROXENE ET ESOMEPRAZOLE (SOUS LA FORME D'ESOMEPRAZOLE MAGNESIUM TRIHYDRATE); AUTHORISATION NUMBER AND DATE: BE382505 20101214
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Boehringer Ingelheim
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McKesson
Colorcon
Merck

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