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ELIQUIS Drug Profile

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Which patents cover Eliquis, and what substitute generic drugs are available?

Eliquis is a drug marketed by Bristol Myers Squibb and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and sixteen patent family members in forty-one countries.

The generic ingredient in ELIQUIS is apixaban. There are twenty-four drug master file entries for this compound. Three 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 list3
Bulk Api Vendors: see list76
Clinical Trials: see list31
Patent Applications: see list578
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:ELIQUIS at DailyMed

Pharmacology for Tradename: ELIQUIS

Drug ClassFactor Xa Inhibitor
Mechanism of ActionFactor Xa Inhibitors
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bristol Myers Squibb
ELIQUIS
apixaban
TABLET;ORAL202155-002Dec 28, 2012RXYesYes► Subscribe► Subscribe
Bristol Myers Squibb
ELIQUIS
apixaban
TABLET;ORAL202155-002Dec 28, 2012RXYesYes► Subscribe► Subscribe
Bristol Myers Squibb
ELIQUIS
apixaban
TABLET;ORAL202155-001Dec 28, 2012RXYesNo6,413,980► SubscribeYY ► Subscribe
Bristol Myers Squibb
ELIQUIS
apixaban
TABLET;ORAL202155-002Dec 28, 2012RXYesYes6,413,980► SubscribeYY ► Subscribe
Bristol Myers Squibb
ELIQUIS
apixaban
TABLET;ORAL202155-002Dec 28, 2012RXYesYes9,326,945► SubscribeY ► Subscribe
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Paragraph IV activity for: ELIQUIS

Drugname Dosage Strength RLD Submissiondate
apixabanTablets2.5 mg and 5 mgEliquis12/28/2016

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
7,531,535Lactam-containing compounds and derivatives thereof as factor Xa inhibitors► Subscribe
6,673,810 Imidazo-heterobicycles as factor Xa inhibitors► Subscribe
7,005,435Lactam-containing compounds and derivatives thereof as factor Xa inhibitors► Subscribe
7,338,963Lactam-containing compounds and derivatives thereof as factor Xa inhibitors► Subscribe
8,470,854Lactam-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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International Patent Family for Tradename: ELIQUIS

Country Document Number Estimated Expiration
Israel160693► Subscribe
TaiwanI225862► Subscribe
Slovenia1427415► Subscribe
Japan5846647► Subscribe
Colombia6640207► 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 Certificates for Tradename: ELIQUIS

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB11/042United Kingdom► SubscribePRODUCT 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
2011012,C1427415Lithuania► SubscribePRODUCT NAME: APIXABANUM; REGISTRATION NO/DATE: EU/1/11/691/001 - EU/1/11/691/005 20110518
00500Netherlands► SubscribePRODUCT NAME: APIXABAN DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/11/691/001-005 20110518
1427415/01Switzerland► SubscribePRODUCT NAME: APIXABAN; REGISTRATION NO/DATE: SWISSMEDIC 61549 26.08.2011
90029-7Sweden► SubscribePRODUCT NAME: APIXABAN OCH FARMACEUTISKT ACCEPTABLA SALTER DAERAV; REG. NO/DATE: EU/1/11/691/001-005 20110518
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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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