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Dasatinib - Generic Drug Details

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Dasatinib is the generic ingredient in two branded drugs marketed by Apotex Inc and Bristol Myers Squibb, and is included in two NDAs. There are five patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has one hundred and seven patent family members in thirty-nine countries.

There are six drug master file entries for dasatinib. Two suppliers are listed for this compound.

Summary for Generic Name: dasatinib

Tradenames:2
Patents:5
Applicants:2
NDAs:2
Drug Master File Entries: see list6
Suppliers / Packaging: see list2
Therapeutic Class:Antineoplastics
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: dasatinib

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bristol Myers Squibb
SPRYCEL
dasatinib
TABLET;ORAL021986-005Oct 28, 2010RXNo6,596,746► subscribeYY ► subscribe
Bristol Myers Squibb
SPRYCEL
dasatinib
TABLET;ORAL021986-004May 30, 2008RXYes7,125,875► subscribe ► subscribe
Apotex Inc
DASATINIB
dasatinib
TABLET;ORAL202103-002Jun 10, 2016RXNo► subscribe► subscribe
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Non-Orange Book Patents for Generic Ingredient: dasatinib

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
8,716,323Cyclic protein tyrosine kinase inhibitors► subscribe
6,979,694 Cyclic protein tyrosine kinase inhibitors► subscribe
9,382,219Cyclic 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 Ingredient: dasatinib

Country Document Number Estimated Expiration
Israel177280► subscribe
TaiwanI338004► subscribe
BrazilPI0515721► 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: DASATINIB

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
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
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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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