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PRILOSEC OTC Drug Profile
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Which patents cover Prilosec Otc, and what generic alternatives are available?
Prilosec Otc is a drug marketed by Astrazeneca Pharms 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. Thirty-nine 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 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 174 |
| Clinical Trials: | 23 |
| Patent Applications: | 3,707 |
| 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 |
| Corcept Therapeutics | Phase 1 |
| The University of Texas Health Science Center at San Antonio | Phase 0 |
Paragraph IV (Patent) Challenges for PRILOSEC OTC
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| PRILOSEC OTC | TABLET, DELAYED RELEASE;ORAL | omeprazole magnesium | 021229 | 2012-03-30 |
| PRILOSEC OTC | TABLET, DELAYED RELEASE;ORAL | omeprazole magnesium | 021229 | 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 Pharms | PRILOSEC OTC | omeprazole magnesium | TABLET, DELAYED RELEASE;ORAL | 021229-001 | Jun 20, 2003 | OTC | Yes | Yes | Start Trial | Start Trial | Start 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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Astrazeneca Pharms | PRILOSEC OTC | omeprazole magnesium | TABLET, DELAYED RELEASE;ORAL | 021229-001 | Jun 20, 2003 | Start Trial | Start Trial |
| Astrazeneca Pharms | PRILOSEC OTC | omeprazole magnesium | TABLET, DELAYED RELEASE;ORAL | 021229-001 | Jun 20, 2003 | Start Trial | Start Trial |
| Astrazeneca Pharms | PRILOSEC OTC | omeprazole magnesium | TABLET, DELAYED RELEASE;ORAL | 021229-001 | Jun 20, 2003 | Start Trial | Start Trial |
| Astrazeneca Pharms | PRILOSEC OTC | omeprazole magnesium | TABLET, DELAYED RELEASE;ORAL | 021229-001 | Jun 20, 2003 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for PRILOSEC OTC
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Cyprus | 1860 | Start Trial |
| European Patent Office | 0723434 | Start Trial |
| Slovenia | 1131316 | Start Trial |
| Poland | 175999 | Start Trial |
| >Country | >Patent Number | >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 | Start Trial | PRODUCT NAME: ESOMEPRAZOLE AS MAGNESIUM TRIHYDRATE; REGISTERED: SE 15945 20000310; SE 15946 20000310; UK PL 17901/0068-0069 20000727 |
| 1411900 | 2011/016 | Ireland | Start 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 | Start 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 |
| 0984957 | SPC/GB11/013 | United Kingdom | Start Trial | PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
