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Last Updated: May 20, 2022

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-two suppliers are listed for this compound. Additional details are available on the omeprazole magnesium profile page.

Drug patent expirations by year for PRILOSEC OTC
Drug Prices for PRILOSEC OTC

See drug prices for PRILOSEC OTC

Drug Sales Revenue Trends for PRILOSEC OTC

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Recent Clinical Trials for PRILOSEC OTC

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

SponsorPhase
Emory UniversityPhase 4
Alexion PharmaceuticalsPhase 1
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 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 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 See Plans and Pricing See Plans and Pricing
Astrazeneca PRILOSEC OTC omeprazole magnesium TABLET, DELAYED RELEASE;ORAL 021229-001 Jun 20, 2003 See Plans and Pricing See Plans and Pricing
Astrazeneca PRILOSEC OTC omeprazole magnesium TABLET, DELAYED RELEASE;ORAL 021229-001 Jun 20, 2003 See Plans and Pricing See Plans and Pricing
Astrazeneca PRILOSEC OTC omeprazole magnesium TABLET, DELAYED RELEASE;ORAL 021229-001 Jun 20, 2003 See Plans and Pricing See Plans and Pricing
>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
Czechoslovakia 241150 METHOD OF 5-METHOXY-2-(/4-METHOXY-3,5-DIMETHYL-2-PYRIDINYL/-METHYL/)-1,H-BENZIMIDAZOLE'S NEW SALTS PRODUCTION See Plans and Pricing
Czech Republic 9600069 See Plans and Pricing
Brazil 9506028 See Plans and Pricing
Norway 960837 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for PRILOSEC OTC

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
0984957 SPC/GB11/013 United Kingdom See Plans and Pricing PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
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 2012/048 Ireland See Plans and Pricing 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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 verification 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.