PRILOSEC OTC Drug Patent Profile

✉ Email this page to a colleague

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. Fifty-one 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 5^th, 2009.

Sign Up

AI Research Assistant

Questions you can ask:

What is the 5 year forecast for PRILOSEC OTC?
What are the global sales for PRILOSEC OTC?
What is Average Wholesale Price for PRILOSEC OTC?

Summary for PRILOSEC OTC

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	52
Clinical Trials:	51
Patent Applications:	83
Drug Prices:	Drug price information for PRILOSEC OTC
Drug Sales Revenues:	Drug sales revenues for PRILOSEC OTC
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PRILOSEC OTC
What excipients (inactive ingredients) are in PRILOSEC OTC?	PRILOSEC OTC excipients list
DailyMed Link:	PRILOSEC OTC at DailyMed

Drug patent expirations by year for PRILOSEC OTC

Recent Clinical Trials for PRILOSEC OTC

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

Sponsor	Phase
Pfizer	Phase 1
Carlos Roberto Simons-Linares	Phase 4
Emory University	Phase 4

See all PRILOSEC OTC clinical trials

Pharmacology for PRILOSEC OTC

Drug Class	Proton Pump Inhibitor
Mechanism of Action	Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors

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

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Sign Up
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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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

Subscribe to access the full database, or Sign Up
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	⤷ Sign Up	⤷ Sign Up
Astrazeneca	PRILOSEC OTC	omeprazole magnesium	TABLET, DELAYED RELEASE;ORAL	021229-001	Jun 20, 2003	⤷ Sign Up	⤷ Sign Up
Astrazeneca	PRILOSEC OTC	omeprazole magnesium	TABLET, DELAYED RELEASE;ORAL	021229-001	Jun 20, 2003	⤷ Sign Up	⤷ Sign Up
Astrazeneca	PRILOSEC OTC	omeprazole magnesium	TABLET, DELAYED RELEASE;ORAL	021229-001	Jun 20, 2003	⤷ Sign Up	⤷ Sign Up
Astrazeneca	PRILOSEC OTC	omeprazole magnesium	TABLET, DELAYED RELEASE;ORAL	021229-001	Jun 20, 2003	⤷ Sign Up	⤷ Sign Up
Astrazeneca	PRILOSEC OTC	omeprazole magnesium	TABLET, DELAYED RELEASE;ORAL	021229-001	Jun 20, 2003	⤷ Sign Up	⤷ Sign Up
>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.

Subscribe to access the full database, or Sign Up
Country	Patent Number	Title	Estimated Expiration
Latvia	5393	Panemiens granulu iegusanai	⤷ Sign Up
Hungary	9600575		⤷ Sign Up
Estonia	03280	Pidurdatud vabanemisega ravimkuulikesed ja neid sisaldav ravimpreparaat	⤷ Sign Up
Hong Kong	52897	Use of specific core material and layers to obtain pharmaceutical formulations stable to discolouration of omeprazole	⤷ Sign Up
Yugoslavia	68187		⤷ Sign Up
Iceland	1363		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for PRILOSEC OTC

Subscribe to access the full database, or Sign Up
Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0124495	SPC/GB01/006	United Kingdom	⤷ Sign Up	PRODUCT NAME: ESOMEPRAZOLE AS MAGNESIUM TRIHYDRATE; REGISTERED: SE 15945 20000310; SE 15946 20000310; UK PL 17901/0068-0069 20000727
0984957	2012/048	Ireland	⤷ Sign Up	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
0984957	SPC/GB11/013	United Kingdom	⤷ Sign Up	PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
1411900	SPC/GB11/015	United Kingdom	⤷ Sign Up	PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
1411900	2011/016	Ireland	⤷ Sign Up	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	2011C/016	Belgium	⤷ Sign Up	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