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Generated: September 22, 2017
What are the generic drug sources for apixaban and what is the scope of apixaban freedom to operate?
Apixaban is the generic ingredient in one branded drug marketed by Bristol Myers Squibb and is included in one NDA. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.| Tradenames: | 1 |
| Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: see list | 24 |
| Suppliers / Packagers: see list | 2 |
| Bulk Api Vendors: see list | 76 |
| Clinical Trials: see list | 114 |
| Patent Applications: see list | 1,301 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | apixaban at DailyMed |
| Drug Class | Factor Xa Inhibitor |
| Mechanism of Action | Factor Xa Inhibitors |
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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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 6,989,391 | Lactam-containing compounds and derivatives thereof as factor Xa inhibitors | ► Subscribe | |||||||||||||||||||||||||||
| 7,371,761 | Lactam-containing compounds and derivatives thereof as factor Xa inhibitors | ► Subscribe | |||||||||||||||||||||||||||
| 7,338,963 | Lactam-containing compounds and derivatives thereof as factor Xa inhibitors | ► Subscribe | |||||||||||||||||||||||||||
| 7,005,435 | Lactam-containing compounds and derivatives thereof as factor Xa inhibitors | ► Subscribe | |||||||||||||||||||||||||||
| 6,673,810 | Imidazo-heterobicycles as factor Xa inhibitors | ► Subscribe | |||||||||||||||||||||||||||
| 8,470,854 | Lactam-containing compounds and derivatives thereof as factor XA inhibitors | ► Subscribe | |||||||||||||||||||||||||||
| 6,858,616 | Nitrogen containing heterobicycles as factor Xa inhibitors | ► Subscribe | |||||||||||||||||||||||||||
| 7,960,411 | Lactam-containing compounds and derivatives thereof as factor Xa inhibitors | ► Subscribe | |||||||||||||||||||||||||||
| 8,188,120 | Lactam-containing compounds and derivatives thereof as factor Xa inhibitors | ► Subscribe | |||||||||||||||||||||||||||
| 6,995,172 | Lactam-containing compounds and derivatives thereof as factor Xa inhibitors | ► 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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| China | 1578660 | ► Subscribe | |||||||||||||||||||||||||||
| Canada | 2349330 | ► Subscribe | |||||||||||||||||||||||||||
| Poland | 373299 | ► Subscribe | |||||||||||||||||||||||||||
| Singapore | 182750 | ► Subscribe | |||||||||||||||||||||||||||
| World Intellectual Property Organization (WIPO) | 0039131 | ► Subscribe | |||||||||||||||||||||||||||
| Hong Kong | 1180248 | ► Subscribe | |||||||||||||||||||||||||||
| New Zealand | 601738 | ► Subscribe | |||||||||||||||||||||||||||
| China | 101357914 | ► Subscribe | |||||||||||||||||||||||||||
| Australia | 2011220775 | ► Subscribe | |||||||||||||||||||||||||||
| European Patent Office | 2538925 | ► 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.
Export unavailable in trial.
Subscribe for complete access.
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2011012 | Lithuania | ► Subscribe | PRODUCT NAME: APIXABANUM; REGISTRATION NO/DATE: EU/1/11/691/001 - EU/1/11/691/005 20110518 | ||||||||||||||||||||||||||
| 00500 | Netherlands | ► Subscribe | PRODUCT NAME: APIXABAN DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/11/691/001-005 20110518 | ||||||||||||||||||||||||||
| 11/032 | Ireland | ► Subscribe | PRODUCT NAME: APIXABAN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/11/691/001-005 20110518 | ||||||||||||||||||||||||||
| 1427415/01 | Switzerland | ► Subscribe | FORMER OWNER: BRISTOL-MYERS SQUIBB COMPANY, US | ||||||||||||||||||||||||||
| 2011 00028 | Denmark | ► Subscribe | |||||||||||||||||||||||||||
| 5 5011-2011 | Slovakia | ► Subscribe | FORMER OWNER: BRISTOL-MYERS SQUIBB COMPANY, US | ||||||||||||||||||||||||||
| C0042 | France | ► Subscribe | PRODUCT NAME: APIXABAN, EVENTUELLEMENT SOUS LA FORME D'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/11/691/001 20110518 | ||||||||||||||||||||||||||
| 3 | Finland | ► Subscribe | |||||||||||||||||||||||||||
| C/GB11/042 | United Kingdom | ► Subscribe | PRODUCT NAME: APIXABAN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/11/691/001 20110520; UK EU/1/11/691/002 20110520; UK EU/1/11/691/003 20110520; UK EU/1/11/691/004 20110520; UK EU/1/11/691/005 20110520 | ||||||||||||||||||||||||||
| 0110017 00045 | Estonia | ► Subscribe | PRODUCT NAME: ELIQUIS - APIKSABAAN; REG NO/DATE: C(2011)3595 18.05.2011 | ||||||||||||||||||||||||||
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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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