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Dasatinib - Generic Drug Details

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What are the generic sources for dasatinib and what is the scope of patent protection?

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 twenty-eight patent family members in thirty-nine countries.

There are fourteen drug master file entries for dasatinib. One supplier is listed for this compound.

Summary for dasatinib

International Patents:	128
US Patents:	5
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	14
Suppliers / Packagers:	1
Bulk Api Vendors:	117
Clinical Trials:	306
Patent Applications:	5,031
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for dasatinib
DailyMed Link:	dasatinib at DailyMed

Recent Clinical Trials for dasatinib

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Hoffmann-La Roche	Phase 1
Zhejiang University	Early Phase 1
Yake Biotechnology Ltd.	Early Phase 1

See all dasatinib clinical trials

Pharmacology for dasatinib

Drug Class	Kinase Inhibitor
Mechanism of Action	Protein Kinase Inhibitors Cytochrome P450 3A4 Inhibitors

Medical Subject Heading (MeSH) Categories for dasatinib

Antineoplastic Agents

Protein Kinase Inhibitors

Paragraph IV (Patent) Challenges for DASATINIB

Tradename	Dosage	Ingredient	NDA	Submissiondate
SPRYCEL	TABLET;ORAL	dasatinib	021986	2011-06-17
SPRYCEL	TABLET;ORAL	dasatinib	021986	2010-06-28

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		RX	Yes	Yes
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-006	Oct 28, 2010		RX	Yes	No					Y
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-003	Jun 28, 2006		RX	Yes	No					Y
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-006	Oct 28, 2010		RX	Yes	No					Y
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-001	Jun 28, 2006		RX	Yes	No					Y

Expired US Patents for dasatinib

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-002	Jun 28, 2006
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-001	Jun 28, 2006
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-003	Jun 28, 2006
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-006	Oct 28, 2010
Bristol Myers Squibb	SPRYCEL	dasatinib	TABLET;ORAL	021986-004	May 30, 2008

International Patents for dasatinib

Country	Patent Number	Estimated Expiration
Hong Kong	1244797
New Zealand	513639
Slovenia	1610780
Denmark	1711481
Portugal	1169038

Supplementary Protection Certificates for dasatinib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1169038	92146	Luxembourg		PRODUCT NAME: DASATINIB ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
1169038	6/2013	Austria		PRODUCT NAME: DASATINIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/06/363/001-015 20061120
1169038	13C0003	France		PRODUCT NAME: DASATINIB ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/06/363/001 20061122
1169038	122013000012	Germany		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	132013902119320	Italy		PRODUCT NAME: DASATINIB E I SUOI SALI FARMACEUTICAMENTE ACCETTABILI(SPRYCEL); AUTHORISATION NUMBER(S) AND DATE(S): DA EU/1/06/363/001 A EU/I/06/363/015, 20061120