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Last Updated: October 22, 2020

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

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

Recent Clinical Trials for DASATINIB

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

SponsorPhase
PfizerPhase 1/Phase 2
Technische Universität DresdenPhase 1/Phase 2
Novartis PharmaceuticalsPhase 1/Phase 2

See all DASATINIB clinical trials

Pharmacology for DASATINIB
Medical Subject Heading (MeSH) Categories for DASATINIB
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 021986-003 Jun 28, 2006 RX Yes No   Start Trial   Start Trial   Start Trial
Bristol Myers Squibb SPRYCEL dasatinib TABLET;ORAL 021986-002 Jun 28, 2006 RX Yes No   Start Trial   Start Trial Y   Start Trial
Bristol Myers Squibb SPRYCEL dasatinib TABLET;ORAL 021986-002 Jun 28, 2006 RX Yes No   Start Trial   Start Trial   Start Trial
Bristol Myers Squibb SPRYCEL dasatinib TABLET;ORAL 021986-001 Jun 28, 2006 RX Yes No   Start Trial   Start Trial Y   Start Trial
Bristol Myers Squibb SPRYCEL dasatinib TABLET;ORAL 021986-006 Oct 28, 2010 RX Yes No   Start Trial   Start Trial   Start Trial
Apotex Inc DASATINIB dasatinib TABLET;ORAL 202103-003 Jun 10, 2016 DISCN No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for DASATINIB

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bristol Myers Squibb SPRYCEL dasatinib TABLET;ORAL 021986-001 Jun 28, 2006   Start Trial   Start Trial
Bristol Myers Squibb SPRYCEL dasatinib TABLET;ORAL 021986-006 Oct 28, 2010   Start Trial   Start Trial
Bristol Myers Squibb SPRYCEL dasatinib TABLET;ORAL 021986-004 May 30, 2008   Start Trial   Start Trial
Bristol Myers Squibb SPRYCEL dasatinib TABLET;ORAL 021986-002 Jun 28, 2006   Start Trial   Start Trial
Bristol Myers Squibb SPRYCEL dasatinib TABLET;ORAL 021986-005 Oct 28, 2010   Start Trial   Start Trial
Bristol Myers Squibb SPRYCEL dasatinib TABLET;ORAL 021986-003 Jun 28, 2006   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for DASATINIB

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1169038 300567 Netherlands   Start Trial PRODUCT NAME: DASATINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/06/363/001 - 009 20061120
1169038 C01169038/01 Switzerland   Start Trial FORMER OWNER: BRISTOL-MYERS SQUIBB HOLDINGS IRELAND, CH
1169038 6/2013 Austria   Start Trial PRODUCT NAME: DASATINIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/06/363/001-015 20061120
1169038 122013000012 Germany   Start Trial 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 92146 Luxembourg   Start Trial PRODUCT NAME: DASATINIB ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
1169038 CA 2013 00006 Denmark   Start Trial PRODUCT NAME: DASATINIB OG FARMACEUTISK ACCEPTABLE SALTE DERAF, HERUNDER MONOHYDRATET; REG. NO/DATE: EU/1/06/363/001-015 20061122
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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AstraZeneca

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