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Last Updated: March 29, 2024

PRILOSEC OTC Drug Patent Profile


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

Prilosec Otc is a drug marketed by Astrazeneca 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. 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 Otc

A generic version of PRILOSEC OTC 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 OTC
Drug Prices for PRILOSEC OTC

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Drug Sales Revenue Trends for PRILOSEC OTC

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Recent Clinical Trials for PRILOSEC OTC

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SponsorPhase
Carlos Roberto Simons-LinaresPhase 4
Emory UniversityPhase 4
Achillion, a wholly owned subsidiary of AlexionPhase 1

See all PRILOSEC OTC clinical trials

Pharmacology for PRILOSEC OTC
Paragraph IV (Patent) Challenges for PRILOSEC OTC
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
PRILOSEC OTC Delayed-release Tablets omeprazole magnesium 20 mg 021229 1 2012-03-30
PRILOSEC OTC Delayed-release Capsules omeprazole magnesium 20 mg 021229 1 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 PRILOSEC OTC omeprazole magnesium TABLET, DELAYED RELEASE;ORAL 021229-001 Jun 20, 2003 OTC Yes Yes ⤷  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 OTC

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca PRILOSEC OTC omeprazole magnesium TABLET, DELAYED RELEASE;ORAL 021229-001 Jun 20, 2003 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca PRILOSEC OTC omeprazole magnesium TABLET, DELAYED RELEASE;ORAL 021229-001 Jun 20, 2003 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca PRILOSEC OTC omeprazole magnesium TABLET, DELAYED RELEASE;ORAL 021229-001 Jun 20, 2003 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca PRILOSEC OTC omeprazole magnesium TABLET, DELAYED RELEASE;ORAL 021229-001 Jun 20, 2003 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca PRILOSEC OTC omeprazole magnesium TABLET, DELAYED RELEASE;ORAL 021229-001 Jun 20, 2003 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca PRILOSEC OTC omeprazole magnesium TABLET, DELAYED RELEASE;ORAL 021229-001 Jun 20, 2003 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca PRILOSEC OTC omeprazole magnesium TABLET, DELAYED RELEASE;ORAL 021229-001 Jun 20, 2003 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for PRILOSEC OTC

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

Country Patent Number Title Estimated Expiration
Mexico 9600856 PREPARACION FARMACEUTICA DE UNIDADES MULTIPLES, QUE CONTIENEN UN INHIBIDOR DE LA BOMBA DE PROTONES. (MULTIPLE UNIT PHARMACEUTICAL PREPARATION CONTAINING PROTON PUMP INHIBITOR.) ⤷  Try a Trial
Singapore 52365 New pharmaceutical formulation ⤷  Try a Trial
Hungary 193557 PROCESS FOR PREPARING SALTS OF OMEPRAZOLE ⤷  Try a Trial
Australia 1901700 ⤷  Try a Trial
European Patent Office 0502556 Utilisation d'un matériau à noyau et de couches pour obtenir des formulations pharmaceutiques stable au changement de couleur des composés sensibles aux acides (Use of specific core material and layers to obtain pharmaceutical formulations stable to discolouration of acid labile compounds) ⤷  Try a Trial
Japan H09502738 ⤷  Try a Trial
Japan H0667837 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for PRILOSEC OTC

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
1411900 2011C/016 Belgium ⤷  Try a Trial PRODUCT NAME: NAPROXENE ET ESOMEPRAZOLE (SOUS LA FORME D'ESOMEPRAZOLE MAGNESIUM TRIHYDRATE); AUTHORISATION NUMBER AND DATE: BE382505 20101214
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
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
1411900 SPC/GB11/015 United Kingdom ⤷  Try a Trial PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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