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.
Summary for PRILOSEC OTC
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 52 |
Clinical Trials: | 50 |
Patent Applications: | 91 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information 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 |
Recent Clinical Trials for PRILOSEC OTC
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Carlos Roberto Simons-Linares | Phase 4 |
Emory University | Phase 4 |
Achillion, a wholly owned subsidiary of Alexion | Phase 1 |
Pharmacology for PRILOSEC OTC
Drug Class | Proton Pump Inhibitor |
Mechanism of Action | Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes 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
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 |