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Last Updated: November 8, 2024

Dasatinib - Generic Drug Details


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

Dasatinib is the generic ingredient in three branded drugs marketed by Apotex, Nanocopoeia, and Bristol Myers Squibb, and is included in four 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 fifty-three patent family members in twenty-nine countries.

There are fourteen drug master file entries for dasatinib. Four suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for dasatinib
Recent Clinical Trials for dasatinib

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

SponsorPhase
Hospital Universitario Dr. Jose E. GonzalezPhase 2
Fernando De la Garza SalazarPhase 2
Institut Paoli-CalmettesPhase 2

See all dasatinib clinical trials

Generic filers with tentative approvals for DASATINIB
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up80MGTABLET;ORAL
⤷  Sign Up⤷  Sign Up70MGTABLET;ORAL
⤷  Sign Up⤷  Sign Up50MGTABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for dasatinib
Medical Subject Heading (MeSH) Categories for dasatinib
Paragraph IV (Patent) Challenges for DASATINIB
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
SPRYCEL Tablets dasatinib 80 mg and 140 mg 021986 1 2011-06-17
SPRYCEL Tablets dasatinib 20 mg, 50 mg, 70 mg and 100 mg 021986 1 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 021986-002 Jun 28, 2006 AB RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Bristol Myers Squibb SPRYCEL dasatinib TABLET;ORAL 021986-002 Jun 28, 2006 AB RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Nanocopoeia PHYRAGO dasatinib TABLET;ORAL 216099-005 Dec 5, 2023 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bristol Myers Squibb SPRYCEL dasatinib TABLET;ORAL 021986-006 Oct 28, 2010 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bristol Myers Squibb SPRYCEL dasatinib TABLET;ORAL 021986-004 May 30, 2008 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>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 021986-002 Jun 28, 2006 ⤷  Sign Up ⤷  Sign Up
Bristol Myers Squibb SPRYCEL dasatinib TABLET;ORAL 021986-006 Oct 28, 2010 ⤷  Sign Up ⤷  Sign Up
Bristol Myers Squibb SPRYCEL dasatinib TABLET;ORAL 021986-002 Jun 28, 2006 ⤷  Sign Up ⤷  Sign Up
Bristol Myers Squibb SPRYCEL dasatinib TABLET;ORAL 021986-001 Jun 28, 2006 ⤷  Sign Up ⤷  Sign Up
Bristol Myers Squibb SPRYCEL dasatinib TABLET;ORAL 021986-004 May 30, 2008 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for dasatinib

Country Patent Number Title Estimated Expiration
Norway 338049 ⤷  Sign Up
Norway 20072179 ⤷  Sign Up
Spain 2337272 ⤷  Sign Up
China 1980909 Process for preparing 2-aminothiazole-5-aromatic carboxamides as kinase inhibitors ⤷  Sign Up
South Africa 200606242 PROCESS FOR PREPARING 2-AMINOTHIAZOLE-5-AROMATIC CARBOXAMIDES AS KINASE INHIBITORS ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for dasatinib

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1169038 13C0003 France ⤷  Sign Up PRODUCT NAME: DASATINIB ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/06/363/001 20061122
1169038 2013/003 Ireland ⤷  Sign Up PRODUCT NAME: DASATINIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF.; REGISTRATION NO/DATE: EU/1/06/363/001-015 20061120
1169038 2013C/005 Belgium ⤷  Sign Up PRODUCT NAME: DASATINIB SOUS TOUTES FORMES COUVERTES PAR LA PROTECTION DU BREVET DE BASE INCLUANT LES SOLVATES, LES HYDRATES, TEL QUE LA FORME MONOHYDRATEE, ET LES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/06/363/001 20061122
1169038 122013000012 Germany ⤷  Sign Up 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 ⤷  Sign Up PRODUCT NAME: DASATINIB ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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