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Last Updated: November 30, 2022

Dasatinib - Generic Drug Details


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

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

Dasatinib has forty-seven patent family members in twenty-nine countries.

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

Recent Clinical Trials for dasatinib

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

SponsorPhase
Eva BonfillPhase 2
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Phase 1/Phase 2
Ruijin HospitalPhase 1/Phase 2

See all dasatinib clinical trials

Generic filers with tentative approvals for DASATINIB
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing50MGTABLET;ORAL
See Plans and PricingSee Plans and Pricing140MGTABLET;ORAL
See Plans and PricingSee Plans and Pricing100MGTABLET;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 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Bristol Myers Squibb SPRYCEL dasatinib TABLET;ORAL 021986-006 Oct 28, 2010 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Bristol Myers Squibb SPRYCEL dasatinib TABLET;ORAL 021986-003 Jun 28, 2006 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Bristol Myers Squibb SPRYCEL dasatinib TABLET;ORAL 021986-002 Jun 28, 2006 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Apotex Inc DASATINIB dasatinib TABLET;ORAL 202103-004 Jun 10, 2016 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 021986-003 Jun 28, 2006 See Plans and Pricing See Plans and Pricing
Bristol Myers Squibb SPRYCEL dasatinib TABLET;ORAL 021986-003 Jun 28, 2006 See Plans and Pricing See Plans and Pricing
Bristol Myers Squibb SPRYCEL dasatinib TABLET;ORAL 021986-001 Jun 28, 2006 See Plans and Pricing See Plans and Pricing
Bristol Myers Squibb SPRYCEL dasatinib TABLET;ORAL 021986-002 Jun 28, 2006 See Plans and Pricing See Plans and Pricing
Bristol Myers Squibb SPRYCEL dasatinib TABLET;ORAL 021986-006 Oct 28, 2010 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for dasatinib

Country Patent Number Title Estimated Expiration
China 1980909 Process for preparing 2-aminothiazole-5-aromatic carboxamides as kinase inhibitors See Plans and Pricing
Poland 1711481 See Plans and Pricing
Taiwan I338004 See Plans and Pricing
Cyprus 1109907 See Plans and Pricing
World Intellectual Property Organization (WIPO) 2006052810 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for dasatinib

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1169038 300567 Netherlands See Plans and Pricing PRODUCT NAME: DASATINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/06/363/001 - 009 20061120
1169038 C300567 Netherlands See Plans and Pricing PRODUCT NAME: DASATINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/06/363/001 .... 009 20061120
1169038 1390004-8 Sweden See Plans and Pricing PRODUCT NAME: DASATINIB OCH FARMACEUTISKT GODTAGBARA SALTER DAERAV; REG. NO/DATE: EU/1/06/363/001 20061120
1169038 CA 2013 00006 Denmark See Plans and Pricing PRODUCT NAME: DASATINIB OG FARMACEUTISK ACCEPTABLE SALTE DERAF, HERUNDER MONOHYDRATET; REG. NO/DATE: EU/1/06/363/001-015 20061122
1169038 6/2013 Austria See Plans and Pricing PRODUCT NAME: DASATINIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/06/363/001-015 20061120
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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