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.
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: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 195 |
| Clinical Trials: | 47 |
| Patent Applications: | 3,734 |
| Formulation / Manufacturing: | see details |
| 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 |
See drug prices for PRILOSEC OTC
Recent Clinical Trials for PRILOSEC OTC
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Emory University | Phase 4 |
| Alexion Pharmaceuticals | Phase 1 |
| 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 | 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.
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