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ELIQUIS Drug Profile
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This drug has one hundred and twelve patent family members in forty countries.
The generic ingredient in ELIQUIS is apixaban. There are six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the apixaban profile page.
Summary for Tradename: ELIQUIS
| Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: see list | 2 |
| Drug Prices: : | see details |
Pharmacology for Tradename: ELIQUIS
| Drug Class | Factor Xa Inhibitor |
| Mechanism of Action | Factor Xa Inhibitors |
Clinical Trials for: ELIQUIS
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Type | RLD | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Bristol Myers Squibb | ELIQUIS | apixaban | TABLET;ORAL | 202155-002 | Dec 28, 2012 | RX | Yes | Dec 28, 2017 | |||||||||||||||||||||
Bristol Myers Squibb | ELIQUIS | apixaban | TABLET;ORAL | 202155-002 | Dec 28, 2012 | RX | Yes | Aug 21, 2017 | |||||||||||||||||||||
Bristol Myers Squibb | ELIQUIS | apixaban | TABLET;ORAL | 202155-001 | Dec 28, 2012 | RX | No | 6,413,980 | Dec 22, 2019 | Y | Y | ||||||||||||||||||
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Non-Orange Book Patents for Tradename: ELIQUIS
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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 6,673,810 | Imidazo-heterobicycles as factor Xa inhibitors | <disabled in preview> | |||||||||||||||||||||||||||
| 7,531,535 | Lactam-containing compounds and derivatives thereof as factor Xa inhibitors | <disabled in preview> | |||||||||||||||||||||||||||
| 7,691,846 | Lactam-containing compounds and derivatives thereof as factor Xa inhibitors | <disabled in preview> | |||||||||||||||||||||||||||
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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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International Patent Family for Tradename: ELIQUIS
| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Colombia | 5560567 | <disabled in preview> | |||||||||||||||||||||||||||
| Colombia | 6640207 | <disabled in preview> | |||||||||||||||||||||||||||
| Australia | 759711 | <disabled in preview> | |||||||||||||||||||||||||||
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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 Certificates for Tradename: ELIQUIS
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 11/032 | Ireland | <disabled> | PRODUCT NAME: APIXABAN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/11/691/001-005 20110518 | ||||||||||||||||||||||||||
| 2011012,C1427415 | Lithuania | <disabled> | PRODUCT NAME: APIXABANUM; REGISTRATION NO/DATE: EU/1/11/691/001 - EU/1/11/691/005 20110518 | ||||||||||||||||||||||||||
| 0110017 00045 | Estonia | <disabled> | PRODUCT NAME: ELIQUIS - APIKSABAAN; REG NO/DATE: C(2011)3595 18.05.2011 | ||||||||||||||||||||||||||
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