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Generated: June 28, 2017
Which patents cover Prilosec Otc, and what generic Prilosec Otc alternatives are available?
Prilosec Otc is a drug marketed by Astrazeneca Pharms and is included in one NDA. There are two patents protecting this drug and two Paragraph IV challenges.| Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: see list | 2 |
| Bulk Api Vendors: see list | 106 |
| Clinical Trials: see list | 83 |
| Patent Applications: see list | 5,665 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see details |
| DailyMed Link: | PRILOSEC OTC at DailyMed |
| 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 | 6,428,810 | ► Subscribe | ► Subscribe | ||||||||||||||||||
Astrazeneca Pharms | PRILOSEC OTC | omeprazole magnesium | TABLET, DELAYED RELEASE;ORAL | 021229-001 | Jun 20, 2003 | OTC | Yes | Yes | 6,403,616 | ► Subscribe | ► Subscribe | ||||||||||||||||||
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| 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 | 5,690,960 | ► Subscribe | ||||||||||||||||||||||
Astrazeneca Pharms | PRILOSEC OTC | omeprazole magnesium | TABLET, DELAYED RELEASE;ORAL | 021229-001 | Jun 20, 2003 | 5,817,338 | ► Subscribe | ||||||||||||||||||||||
Astrazeneca Pharms | PRILOSEC OTC | omeprazole magnesium | TABLET, DELAYED RELEASE;ORAL | 021229-001 | Jun 20, 2003 | 4,738,974 | ► Subscribe | ||||||||||||||||||||||
Astrazeneca Pharms | PRILOSEC OTC | omeprazole magnesium | TABLET, DELAYED RELEASE;ORAL | 021229-001 | Jun 20, 2003 | 4,853,230*PED | ► Subscribe | ||||||||||||||||||||||
Astrazeneca Pharms | PRILOSEC OTC | omeprazole magnesium | TABLET, DELAYED RELEASE;ORAL | 021229-001 | Jun 20, 2003 | 5,900,424 | ► Subscribe | ||||||||||||||||||||||
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| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| omeprazole magnesium | Delayed-release Tablets | 20 mg | Prilosec OTC | 3/30/2012 |
| omeprazole magnesium | Delayed-release Capsules | 20 mg | Prilosec OTC | 3/19/2007 |
| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Brazil | 9915421 | ► Subscribe | |||||||||||||||||||||||||||
| Australia | 1901700 | ► Subscribe | |||||||||||||||||||||||||||
| Israel | 142474 | ► Subscribe | |||||||||||||||||||||||||||
| China | 100503598 | ► Subscribe | |||||||||||||||||||||||||||
| China | 1325300 | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C/GB11/015 | United Kingdom | ► Subscribe | PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105 | ||||||||||||||||||||||||||
| C/GB11/013 | United Kingdom | ► Subscribe | PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105 | ||||||||||||||||||||||||||
| 11/016 | Ireland | ► Subscribe | PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE MODIFIED-RELEASE TABLETS; NAT REGISTRATION NO/DATE: PA0970/060/001 20101221; FIRST REGISTRATION NO/DATE: PL17901/0263-0001 20101105 | ||||||||||||||||||||||||||
| 12/048 | Ireland | ► Subscribe | 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 | ||||||||||||||||||||||||||
| C/GB01/006 | United Kingdom | ► Subscribe | PRODUCT NAME: ESOMEPRAZOLE AS MAGNESIUM TRIHYDRATE; REGISTERED: SE 15945 20000310; SE 15946 20000310; UK PL 17901/0068-0069 20000727 | ||||||||||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
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 verifification 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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