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Generated: September 22, 2017
What are the generic drug sources for aspirin and what is the scope of aspirin freedom to operate?
Aspirin is the generic ingredient in fifty-three branded drugs marketed by Bayer, New Haven Pharms, Plx Pharma, Savage Labs, Actavis Elizabeth, Watson Labs, Allergan Sales Llc, Ivax Pharms, Halsey, Puracap Pharm, Nostrum Labs Inc, Hikma Intl Pharms, Quantum Pharmics, Lannett, PII, Sandoz, Nexgen Pharma Inc, Mayne Pharma Inc, Stevens J, Vintage Pharms Llc, Sun Pharm Inds, Medicis, Prinston Inc, Teva, Alra, Ivax Sub Teva Pharms, Xanodyne Pharm, Ingenus Pharms Nj, Oxford Pharms, Meda Pharms, Heritage Pharms Inc, Barr, Sandoz Inc, Par Pharm Inc, Zydus Pharms Usa Inc, Impax Labs Inc, Boehringer Ingelheim, Amneal Pharms, Schwarz Pharma, Abbott, Caraco, Par Pharm, Medpointe Pharm Hlc, Robins Ah, Mcneil, Aralez Pharms, Endo Pharms, Actavis Labs Fl Inc, Roxane, Sanofi Aventis Us, Bristol Myers Squibb, and Aaipharma Llc, and is included in eighty-one NDAs. There are ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.| Tradenames: | 53 |
| Patents: | 10 |
| Applicants: | 52 |
| NDAs: | 81 |
| Drug Master File Entries: see list | 21 |
| Suppliers / Packagers: see list | 1 |
| Bulk Api Vendors: see list | 73 |
| Clinical Trials: see list | 1,116 |
| Patent Applications: see list | 7,697 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | aspirin at DailyMed |
| Ingredient-type | Nonsteroidal Anti-inflammatory Compounds |
| Drug Class | Nonsteroidal Anti-inflammatory Drug Platelet Aggregation Inhibitor |
| Mechanism of Action | Cyclooxygenase Inhibitors |
| Physiological Effect | Decreased Prostaglandin Production Decreased Platelet Aggregation |
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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 | |||||||||||||
| 9,687,551 | 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 | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Slovenia | 1343529 | ► Subscribe | |||||||||||||
| Mexico | 340951 | ► Subscribe | |||||||||||||
| South Korea | 20030072565 | ► Subscribe | |||||||||||||
| Japan | 2005506303 | ► Subscribe | |||||||||||||
| World Intellectual Property Organization (WIPO) | 02085414 | ► Subscribe | |||||||||||||
| Canada | 2850187 | ► Subscribe | |||||||||||||
| Spain | 2317873 | ► Subscribe | |||||||||||||
| Austria | 414542 | ► Subscribe | |||||||||||||
| Japan | 4958381 | ► Subscribe | |||||||||||||
| China | 102258457 | ► 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 | ||||||||||||
| 2012000017 | Germany | ► Subscribe | PRODUCT NAME: ASPIRIN UND ESOMEPRAZOL - MAGNESIUM-TRIHYDRAT; NAT. REGISTRATION NO/DATE: 81047.00.00 20110930 FIRST REGISTRATION: PORTUGAL 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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