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Serving leading biopharmaceutical companies globally:

Deloitte
Healthtrust
Cipla
Harvard Business School
Fish and Richardson
Covington
Express Scripts
Citi
Boehringer Ingelheim
US Department of Justice

Generated: January 20, 2018

DrugPatentWatch Database Preview

Dasatinib - Generic Drug Details

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What are the generic sources for dasatinib and what is the scope of dasatinib freedom to operate?

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.

Dasatinib has one hundred and nineteen patent family members in thirty-nine countries.

There are ten drug master file entries for dasatinib. Two suppliers are listed for this compound.
Pharmacology for dasatinib
Medical Subject Heading (MeSH) Categories for dasatinib

US Patents and Regulatory Information for dasatinib

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;ORAL 021986-004 May 30, 2008 AB RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Bristol Myers Squibb SPRYCEL dasatinib TABLET;ORAL 021986-006 Oct 28, 2010 RX Yes No ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Bristol Myers Squibb SPRYCEL dasatinib TABLET;ORAL 021986-001 Jun 28, 2006 AB RX Yes No ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Bristol Myers Squibb SPRYCEL dasatinib TABLET;ORAL 021986-003 Jun 28, 2006 AB RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Bristol Myers Squibb SPRYCEL dasatinib TABLET;ORAL 021986-005 Oct 28, 2010 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Bristol Myers Squibb SPRYCEL dasatinib TABLET;ORAL 021986-001 Jun 28, 2006 AB RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Bristol Myers Squibb SPRYCEL dasatinib TABLET;ORAL 021986-006 Oct 28, 2010 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Apotex Inc DASATINIB dasatinib TABLET;ORAL 202103-003 Jun 10, 2016 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Bristol Myers Squibb SPRYCEL dasatinib TABLET;ORAL 021986-002 Jun 28, 2006 AB RX Yes No ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Bristol Myers Squibb SPRYCEL dasatinib TABLET;ORAL 021986-002 Jun 28, 2006 AB RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Non-Orange Book US Patents for 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
7,189,854 Cyclic protein tyrosine kinase inhibitors ➤ Subscribe
8,242,270 Process for preparing 2-aminothiazole-5-aromatic carboxamides as kinase inhibitors ➤ Subscribe
9,382,219 Cyclic protein tyrosine kinase inhibitors ➤ Subscribe
8,716,323 Cyclic protein tyrosine kinase inhibitors ➤ Subscribe
7,091,223 Cyclic protein tyrosine kinase inhibitors ➤ Subscribe
6,979,694 Cyclic protein tyrosine kinase inhibitors ➤ Subscribe
8,993,567 Cyclic protein tyrosine kinase inhibitors ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for dasatinib

Supplementary Protection Certificates for dasatinib

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2013000012 Germany ➤ Subscribe PRODUCT 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
1169038/01 Switzerland ➤ Subscribe FORMER OWNER: BRISTOL-MYERS SQUIBB HOLDINGS IRELAND, CH
0567 Netherlands ➤ Subscribe PRODUCT NAME: DASATINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/06/363/001 - 009 20061120
00567 Netherlands ➤ Subscribe PRODUCT NAME: DASATINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/06/363/001 .... 009 20061120
90004-8 Sweden ➤ Subscribe PRODUCT NAME: DASATINIB OCH FARMACEUTISKT GODTAGBARA SALTER DAERAV; REG. NO/DATE: EU/1/06/363/001 20061120
146 Luxembourg ➤ Subscribe PRODUCT NAME: DASATINIB ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
2013 00006 Denmark ➤ Subscribe PRODUCT NAME: DASATINIB OG FARMACEUTISK ACCEPTABLE SALTE DERAF, HERUNDER MONOHYDRATET; REG. NO/DATE: EU/1/06/363/001-015 20061122
13/003 Ireland ➤ Subscribe PRODUCT NAME: DASATINIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF.; REGISTRATION NO/DATE: EU/1/06/363/001-015 20061120
C0003 France ➤ Subscribe PRODUCT NAME: DASATINIB ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/06/363/001 20061122
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Chubb
Argus Health
Fuji
Johnson and Johnson
Express Scripts
QuintilesIMS
Mallinckrodt
Daiichi Sankyo
US Army

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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