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SPRYCEL Drug Profile

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

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 ten patent family members in thirty-nine countries.

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

Summary for Tradename: SPRYCEL

Patents:5
Applicants:1
NDAs:1
Suppliers / Packagers: see list2
Bulk Api Vendors: see list94
Clinical Trials: see list24
Patent Applications: see list4,049
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:SPRYCEL at DailyMed

Pharmacology for Tradename: SPRYCEL

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bristol Myers Squibb
SPRYCEL
dasatinib
TABLET;ORAL021986-006Oct 28, 2010RXYesNo7,491,725► SubscribeYY ► Subscribe
Bristol Myers Squibb
SPRYCEL
dasatinib
TABLET;ORAL021986-005Oct 28, 2010RXYesNo8,680,103► SubscribeY ► Subscribe
Bristol Myers Squibb
SPRYCEL
dasatinib
TABLET;ORAL021986-004May 30, 2008RXYesYes7,153,856► Subscribe ► Subscribe
Bristol Myers Squibb
SPRYCEL
dasatinib
TABLET;ORAL021986-004May 30, 2008RXYesYes6,596,746► SubscribeYY ► Subscribe
Bristol Myers Squibb
SPRYCEL
dasatinib
TABLET;ORAL021986-001Jun 28, 2006RXYesNo6,596,746► SubscribeYY ► Subscribe
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Paragraph IV activity 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
9,382,219Cyclic protein tyrosine kinase inhibitors► Subscribe
8,242,270Process for preparing 2-aminothiazole-5-aromatic carboxamides as kinase inhibitors► Subscribe
7,091,223Cyclic protein tyrosine kinase inhibitors► Subscribe
8,993,567Cyclic 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
Ukraine87456► Subscribe
Slovenia1610780► Subscribe
South Korea20070020153► Subscribe
Japan5148115► Subscribe
Czech Republic20013677► 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
90004-8Sweden► SubscribePRODUCT NAME: DASATINIB OCH FARMACEUTISKT GODTAGBARA SALTER DAERAV; REG. NO/DATE: EU/1/06/363/001 20061120
1169038/01Switzerland► SubscribeFORMER OWNER: BRISTOL-MYERS SQUIBB HOLDINGS IRELAND, CH
00567Netherlands► 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
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
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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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