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Generated: August 18, 2017
What is the patent landscape for Aspirin, and what generic Aspirin alternatives are available?
Aspirin is a drug marketed by Plx Pharma, Barr, Sandoz Inc, Par Pharm Inc, Impax Labs Inc, and Amneal Pharms. and is included in six NDAs. There are five patents protecting this drug.| Patents: | 5 |
| Applicants: | 6 |
| NDAs: | 6 |
| Bulk Api Vendors: see list | 73 |
| Clinical Trials: see list | 1,107 |
| Patent Applications: see list | 6,503 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see details |
| DailyMed Link: | ASPIRIN at DailyMed |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Plx Pharma | ASPIRIN | aspirin | CAPSULE;ORAL | 203697-001 | Jan 14, 2013 | OTC | Yes | Yes | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Plx Pharma | ASPIRIN | aspirin | CAPSULE;ORAL | 203697-001 | Jan 14, 2013 | OTC | Yes | Yes | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Plx Pharma | ASPIRIN | aspirin | CAPSULE;ORAL | 203697-001 | Jan 14, 2013 | OTC | Yes | Yes | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Par Pharm Inc | ASPIRIN AND DIPYRIDAMOLE | aspirin; dipyridamole | CAPSULE, EXTENDED RELEASE;ORAL | 207944-001 | Jan 18, 2017 | AB | RX | No | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
Amneal Pharms | ASPIRIN AND DIPYRIDAMOLE | aspirin; dipyridamole | CAPSULE, EXTENDED RELEASE;ORAL | 206392-001 | Mar 8, 2016 | AB | RX | No | No | ► Subscribe | ► Subscribe | ► 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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 8,911,752 | Methods of making compositions comprising lecithin oils and NSAIDS for protecting the gastrointestinal tract and providing enhanced therapeutic activity | ► 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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Australia | 2012315545 | ► Subscribe | |||||||||||||||||||||||||||
| Australia | 2001297778 | ► Subscribe | |||||||||||||||||||||||||||
| China | 103957888 | ► Subscribe | |||||||||||||||||||||||||||
| Germany | 60136647 | ► Subscribe | |||||||||||||||||||||||||||
| South Korea | 20140105436 | ► 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 | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | ||||||||||||||||||||||||||
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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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