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Generated: July 22, 2017
What are the generic sources for aspirin; omeprazole and what is the scope of aspirin; omeprazole freedom to operate?
Aspirin; omeprazole is the generic ingredient in one branded drug marketed by Aralez Pharms and is included in one NDA. There are five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.| Tradenames: | 1 |
| Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: see list | 21 |
| Suppliers / Packagers: see list | 1 |
| Clinical Trials: see list | 1,292 |
| Drug Prices: | see low prices |
| DailyMed Link: | aspirin; omeprazole at DailyMed |
| Ingredient-type | Nonsteroidal Anti-inflammatory Compounds |
| Drug Class | Nonsteroidal Anti-inflammatory Drug Platelet Aggregation Inhibitor Proton Pump Inhibitor |
| Mechanism of Action | Cyclooxygenase Inhibitors Proton Pump Inhibitors Cytochrome P450 2C19 Inhibitors |
| Physiological Effect | Decreased Prostaglandin Production Decreased Platelet Aggregation |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Aralez Pharms | YOSPRALA | aspirin; omeprazole | TABLET, DELAYED RELEASE;ORAL | 205103-002 | Sep 14, 2016 | RX | Yes | Yes | 6,926,907 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Aralez Pharms | YOSPRALA | aspirin; omeprazole | TABLET, DELAYED RELEASE;ORAL | 205103-001 | Sep 14, 2016 | RX | Yes | No | 8,206,741 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Aralez Pharms | YOSPRALA | aspirin; omeprazole | TABLET, DELAYED RELEASE;ORAL | 205103-001 | Sep 14, 2016 | RX | Yes | No | 9,364,439 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Aralez Pharms | YOSPRALA | aspirin; omeprazole | TABLET, DELAYED RELEASE;ORAL | 205103-002 | Sep 14, 2016 | RX | Yes | Yes | ► Subscribe | ► Subscribe | |||||||||||||||||||
Aralez Pharms | YOSPRALA | aspirin; omeprazole | TABLET, DELAYED RELEASE;ORAL | 205103-001 | Sep 14, 2016 | RX | Yes | No | 6,926,907 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
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For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 9,161,920 | Pharmaceutical compositions for the coordinated delivery of NSAIDs | ► Subscribe | |||||||||||||||||||||||||||
| 9,198,888 | Pharmaceutical compositions for the coordinated delivery of NSAIDs | ► Subscribe | |||||||||||||||||||||||||||
| 8,557,285 | Pharmaceutical compositions for the coordinated delivery of NSAIDs | ► Subscribe | |||||||||||||||||||||||||||
| 9,220,698 | Method for delivering a pharmaceutical composition to patient in need thereof | ► Subscribe | |||||||||||||||||||||||||||
| 8,858,996 | Pharmaceutical compositions for the coordinated delivery of NSAIDS | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| World Intellectual Property Organization (WIPO) | 2013101897 | ► Subscribe | |||||||||||||||||||||||||||
| Australia | 2009290712 | ► Subscribe | |||||||||||||||||||||||||||
| World Intellectual Property Organization (WIPO) | 02098352 | ► Subscribe | |||||||||||||||||||||||||||
| European Patent Office | 2260837 | ► Subscribe | |||||||||||||||||||||||||||
| European Patent Office | 2344139 | ► 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 | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 5 | Finland | ► Subscribe | |||||||||||||||||||||||||||
| 90013-1 | Sweden | ► Subscribe | PRODUCT NAME: NAPROXEN OCH ESOMEPRAZOL; NAT. REG. NO/DATE: MTNR 43248 20101203; FIRST REG.: GB PL 17901/0263 20101105 | ||||||||||||||||||||||||||
| 858 | Luxembourg | ► Subscribe | 91858, EXPIRES: 20251105 | ||||||||||||||||||||||||||
| 2012 00036 | Denmark | ► Subscribe | |||||||||||||||||||||||||||
| C/GB11/015 | United Kingdom | ► Subscribe | PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105 | ||||||||||||||||||||||||||
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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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