PRILOSEC Drug Patent Profile
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When do Prilosec patents expire, and what generic alternatives are available?
Prilosec is a drug marketed by Astrazeneca and Covis and is included in three NDAs.
The generic ingredient in PRILOSEC is omeprazole magnesium. There are one hundred and thirty-one drug master file entries for this compound. Fifty suppliers are listed for this compound. Additional details are available on the omeprazole magnesium profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Prilosec
A generic version of PRILOSEC was approved as omeprazole magnesium by DR REDDYS LABS LTD on June 5th, 2009.
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Questions you can ask:
- What is the 5 year forecast for PRILOSEC?
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- What is Average Wholesale Price for PRILOSEC?
Summary for PRILOSEC
| US Patents: | 0 |
| Applicants: | 2 |
| NDAs: | 3 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 225 |
| Clinical Trials: | 51 |
| Patent Applications: | 3,992 |
| Drug Prices: | Drug price information for PRILOSEC |
| Drug Sales Revenues: | Drug sales revenues for PRILOSEC |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for PRILOSEC |
| What excipients (inactive ingredients) are in PRILOSEC? | PRILOSEC excipients list |
| DailyMed Link: | PRILOSEC at DailyMed |
Recent Clinical Trials for PRILOSEC
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Pfizer | Phase 1 |
| Carlos Roberto Simons-Linares | Phase 4 |
| Emory University | Phase 4 |
Pharmacology for PRILOSEC
| Drug Class | Proton Pump Inhibitor |
| Mechanism of Action | Cytochrome P450 2C19 Inhibitors Proton Pump Inhibitors |
US Patents and Regulatory Information for PRILOSEC
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Astrazeneca | PRILOSEC | omeprazole | CAPSULE, DELAYED REL PELLETS;ORAL | 019810-003 | Oct 5, 1995 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Covis | PRILOSEC | omeprazole magnesium | FOR SUSPENSION, DELAYED RELEASE;ORAL | 022056-001 | Mar 20, 2008 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Astrazeneca | PRILOSEC | omeprazole | CAPSULE, DELAYED REL PELLETS;ORAL | 019810-001 | Sep 14, 1989 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Astrazeneca | PRILOSEC | omeprazole | CAPSULE, DELAYED REL PELLETS;ORAL | 019810-002 | Jan 15, 1998 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| 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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Covis | PRILOSEC | omeprazole magnesium | FOR SUSPENSION, DELAYED RELEASE;ORAL | 022056-001 | Mar 20, 2008 | ⤷ Sign Up | ⤷ Sign Up |
| Astrazeneca | PRILOSEC | omeprazole | CAPSULE, DELAYED REL PELLETS;ORAL | 019810-001 | Sep 14, 1989 | ⤷ Sign Up | ⤷ Sign Up |
| Astrazeneca | PRILOSEC | omeprazole | CAPSULE, DELAYED REL PELLETS;ORAL | 019810-001 | Sep 14, 1989 | ⤷ Sign Up | ⤷ Sign Up |
| Astrazeneca | PRILOSEC | omeprazole | CAPSULE, DELAYED REL PELLETS;ORAL | 019810-002 | Jan 15, 1998 | ⤷ Sign Up | ⤷ Sign Up |
| Astrazeneca | PRILOSEC | omeprazole | CAPSULE, DELAYED REL PELLETS;ORAL | 019810-003 | Oct 5, 1995 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for PRILOSEC
See the table below for patents covering PRILOSEC around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Greece | 3007448 | ⤷ Sign Up | |
| Ireland | 61837 | Pharmaceutical formulations of acid labile substances for oral use | ⤷ Sign Up |
| Norway | 871790 | ⤷ Sign Up | |
| Austria | 84211 | ⤷ Sign Up | |
| China | 1160062 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for PRILOSEC
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1411900 | SPC/GB11/015 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105 |
| 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 |
| 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 |
| 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 |
| 0005129 | SPC/GB99/015 | United Kingdom | ⤷ Sign Up | SPC/GB99/015, EXPIRES: 20021115 |
| >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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