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Serving leading biopharmaceutical companies globally:

Dow
UBS
Chubb
Farmers Insurance
Julphar
US Army
Healthtrust
Novartis
QuintilesIMS
Accenture

Generated: November 22, 2017

DrugPatentWatch Database Preview

SPRYCEL Drug Profile

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What is the patent landscape for Sprycel, and when can generic versions of Sprycel launch?

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

This drug has one hundred and nineteen patent family members in thirty-nine countries and nine supplementary protection certificates in eight countries.

The generic ingredient in SPRYCEL is dasatinib. There are nine drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the dasatinib profile page.

Pharmacology for SPRYCEL

Medical Subject Heading (MeSH) Categories for SPRYCEL

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
SPRYCEL
dasatinib
TABLET;ORAL021986-006Oct 28, 2010RXYesNo► Subscribe► SubscribeYY ► Subscribe
Bristol Myers Squibb
SPRYCEL
dasatinib
TABLET;ORAL021986-005Oct 28, 2010RXYesNo► Subscribe► SubscribeY ► Subscribe
Bristol Myers Squibb
SPRYCEL
dasatinib
TABLET;ORAL021986-004May 30, 2008ABRXYesYes► Subscribe► Subscribe ► Subscribe
Bristol Myers Squibb
SPRYCEL
dasatinib
TABLET;ORAL021986-004May 30, 2008ABRXYesYes► Subscribe► SubscribeYY ► Subscribe
Bristol Myers Squibb
SPRYCEL
dasatinib
TABLET;ORAL021986-001Jun 28, 2006ABRXYesNo► Subscribe► SubscribeYY ► Subscribe
Bristol Myers Squibb
SPRYCEL
dasatinib
TABLET;ORAL021986-005Oct 28, 2010RXYesNo► Subscribe► Subscribe ► Subscribe
Bristol Myers Squibb
SPRYCEL
dasatinib
TABLET;ORAL021986-001Jun 28, 2006ABRXYesNo► Subscribe► SubscribeYY ► Subscribe
Bristol Myers Squibb
SPRYCEL
dasatinib
TABLET;ORAL021986-006Oct 28, 2010RXYesNo► Subscribe► SubscribeYY ► Subscribe
Bristol Myers Squibb
SPRYCEL
dasatinib
TABLET;ORAL021986-002Jun 28, 2006ABRXYesNo► Subscribe► Subscribe ► Subscribe
Bristol Myers Squibb
SPRYCEL
dasatinib
TABLET;ORAL021986-003Jun 28, 2006ABRXYesNo► Subscribe► SubscribeYY ► Subscribe
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Paragraph IV (Patent) Challenges for SPRYCEL

Drugname Dosage Strength RLD Submissiondate
dasatinibTablets80 mg and 140 mgSprycel6/17/2011
dasatinibTablets80 mg and 140 mgSprycel6/16/2011
dasatinibTablets20 mg, 50 mg, 70 mg and 100 mgSprycel6/28/2010

Non-Orange Book Patents for Tradename: SPRYCEL

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
6,979,694 Cyclic protein tyrosine kinase inhibitors► Subscribe
8,716,323Cyclic protein tyrosine kinase inhibitors► Subscribe
8,993,567Cyclic protein tyrosine kinase inhibitors► Subscribe
8,242,270Process for preparing 2-aminothiazole-5-aromatic carboxamides as kinase inhibitors► Subscribe
9,382,219Cyclic protein tyrosine kinase inhibitors► Subscribe
7,189,854Cyclic protein tyrosine kinase inhibitors► Subscribe
7,091,223Cyclic protein tyrosine kinase 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: SPRYCEL

Country Document Number Estimated Expiration
Portugal1711481► Subscribe
BrazilPI0515721► Subscribe
Russian Federation2260592► Subscribe
Spain2337272► Subscribe
Indonesia30460► Subscribe
Argentina044506► Subscribe
Luxembourg92146► Subscribe
Canada2366932► Subscribe
Japan2002542193► Subscribe
New Zealand542171► 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: SPRYCEL

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
13/003Ireland► SubscribePRODUCT NAME: DASATINIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF.; REGISTRATION NO/DATE: EU/1/06/363/001-015 20061120
90004-8Sweden► SubscribePRODUCT NAME: DASATINIB OCH FARMACEUTISKT GODTAGBARA SALTER DAERAV; REG. NO/DATE: EU/1/06/363/001 20061120
2013000012Germany► SubscribePRODUCT NAME: DASATINIB UND PHARMAZEUTISCH GEEIGNETE SALZE DAVON; REGISTRATION NO/DATE: EU/1/06/363/001-009 EU/1/06/363/010-011 EU/1/06/363/012-015 20061120
00567Netherlands► SubscribePRODUCT NAME: DASATINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/06/363/001 .... 009 20061120
1169038/01Switzerland► SubscribeFORMER OWNER: BRISTOL-MYERS SQUIBB HOLDINGS IRELAND, CH
2013 00006Denmark► SubscribePRODUCT NAME: DASATINIB OG FARMACEUTISK ACCEPTABLE SALTE DERAF, HERUNDER MONOHYDRATET; REG. NO/DATE: EU/1/06/363/001-015 20061122
C0003France► SubscribePRODUCT NAME: DASATINIB ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/06/363/001 20061122
0567Netherlands► SubscribePRODUCT NAME: DASATINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/06/363/001 - 009 20061120
146Luxembourg► SubscribePRODUCT NAME: DASATINIB ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Cerilliant
US Department of Justice
Daiichi Sankyo
Mallinckrodt
Medtronic
AstraZeneca
Baxter
Covington
Farmers Insurance

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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