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Serving 500+ biopharmaceutical companies globally:

Cerilliant
Harvard Business School
Johnson and Johnson
Fuji
Cipla
Medtronic
Federal Trade Commission
Cantor Fitzgerald
QuintilesIMS
Baxter

Generated: September 22, 2017

DrugPatentWatch Database Preview

Apixaban - Generic Drug Details

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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.

Apixaban has one hundred and twenty-two patent family members in forty countries.

There are twenty-four drug master file entries for apixaban. Two suppliers are listed for this compound.

Summary for Generic Name: apixaban

Tradenames:1
Patents:3
Applicants:1
NDAs:1
Drug Master File Entries: see list24
Suppliers / Packagers: see list2
Bulk Api Vendors: see list76
Clinical Trials: see list114
Patent Applications: see list1,301
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:apixaban at DailyMed

Pharmacology for Ingredient: apixaban

Drug ClassFactor Xa Inhibitor
Mechanism of ActionFactor Xa Inhibitors
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bristol Myers Squibb
ELIQUIS
apixaban
TABLET;ORAL202155-001Dec 28, 2012RXYesNo► Subscribe► Subscribe► Subscribe
Bristol Myers Squibb
ELIQUIS
apixaban
TABLET;ORAL202155-001Dec 28, 2012RXYesNo► Subscribe► SubscribeY ► Subscribe
Bristol Myers Squibb
ELIQUIS
apixaban
TABLET;ORAL202155-002Dec 28, 2012RXYesYes► Subscribe► SubscribeYY ► Subscribe
Bristol Myers Squibb
ELIQUIS
apixaban
TABLET;ORAL202155-001Dec 28, 2012RXYesNo► Subscribe► SubscribeYY ► Subscribe
Bristol Myers Squibb
ELIQUIS
apixaban
TABLET;ORAL202155-002Dec 28, 2012RXYesYes► Subscribe► SubscribeY ► Subscribe
Bristol Myers Squibb
ELIQUIS
apixaban
TABLET;ORAL202155-001Dec 28, 2012RXYesNo► Subscribe► Subscribe► Subscribe
Bristol Myers Squibb
ELIQUIS
apixaban
TABLET;ORAL202155-002Dec 28, 2012RXYesYes► Subscribe► Subscribe► Subscribe
Bristol Myers Squibb
ELIQUIS
apixaban
TABLET;ORAL202155-002Dec 28, 2012RXYesYes► Subscribe► SubscribeYY ► Subscribe
Bristol Myers Squibb
ELIQUIS
apixaban
TABLET;ORAL202155-002Dec 28, 2012RXYesYes► Subscribe► Subscribe► Subscribe
Bristol Myers Squibb
ELIQUIS
apixaban
TABLET;ORAL202155-001Dec 28, 2012RXYesNo► Subscribe► SubscribeYY ► Subscribe
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Non-Orange Book Patents for Generic Ingredient: apixaban

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
6,989,391Lactam-containing compounds and derivatives thereof as factor Xa inhibitors► Subscribe
7,371,761Lactam-containing compounds and derivatives thereof as factor Xa inhibitors► Subscribe
7,338,963Lactam-containing compounds and derivatives thereof as factor Xa inhibitors► Subscribe
7,005,435Lactam-containing compounds and derivatives thereof as factor Xa inhibitors► Subscribe
6,673,810 Imidazo-heterobicycles as factor Xa inhibitors► Subscribe
8,470,854Lactam-containing compounds and derivatives thereof as factor XA inhibitors► Subscribe
6,858,616 Nitrogen containing heterobicycles as factor Xa inhibitors► Subscribe
7,960,411Lactam-containing compounds and derivatives thereof as factor Xa inhibitors► Subscribe
8,188,120Lactam-containing compounds and derivatives thereof as factor Xa inhibitors► Subscribe
6,995,172Lactam-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 Ingredient: apixaban

Country Document Number Estimated Expiration
China1578660► Subscribe
Canada2349330► Subscribe
Poland373299► Subscribe
Singapore182750► Subscribe
World Intellectual Property Organization (WIPO)0039131► Subscribe
Hong Kong1180248► Subscribe
New Zealand601738► Subscribe
China101357914► Subscribe
Australia2011220775► Subscribe
European Patent Office2538925► 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: APIXABAN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2011012Lithuania► 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
11/032Ireland► SubscribePRODUCT NAME: APIXABAN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/11/691/001-005 20110518
1427415/01Switzerland► SubscribeFORMER OWNER: BRISTOL-MYERS SQUIBB COMPANY, US
2011 00028Denmark► Subscribe
5 5011-2011Slovakia► SubscribeFORMER OWNER: BRISTOL-MYERS SQUIBB COMPANY, US
C0042France► SubscribePRODUCT NAME: APIXABAN, EVENTUELLEMENT SOUS LA FORME D'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/11/691/001 20110518
3Finland► Subscribe
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
0110017 00045Estonia► SubscribePRODUCT NAME: ELIQUIS - APIKSABAAN; REG NO/DATE: C(2011)3595 18.05.2011
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

UBS
Julphar
Boehringer Ingelheim
Accenture
AstraZeneca
Novartis
Chubb
Baxter
Healthtrust
Medtronic

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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