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Last Updated: March 1, 2024

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 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. 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
Hospital Universitario Dr. Jose E. GonzalezPhase 2
Fernando De la Garza SalazarPhase 2
Princess Maxima Center for Pediatric OncologyPhase 1/Phase 2

See all dasatinib clinical trials

Generic filers with tentative approvals for DASATINIB
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial80MGTABLET;ORAL
⤷  Try a Trial⤷  Try a Trial70MGTABLET;ORAL
⤷  Try a Trial⤷  Try a Trial50MGTABLET;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
Nanocopoeia PHYRAGO dasatinib TABLET;ORAL 216099-004 Dec 5, 2023 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bristol Myers Squibb SPRYCEL dasatinib TABLET;ORAL 021986-003 Jun 28, 2006 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Bristol Myers Squibb SPRYCEL dasatinib TABLET;ORAL 021986-005 Oct 28, 2010 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a 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 021986-003 Jun 28, 2006 ⤷  Try a Trial ⤷  Try a Trial
Bristol Myers Squibb SPRYCEL dasatinib TABLET;ORAL 021986-006 Oct 28, 2010 ⤷  Try a Trial ⤷  Try a Trial
Bristol Myers Squibb SPRYCEL dasatinib TABLET;ORAL 021986-001 Jun 28, 2006 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for dasatinib

Country Patent Number Title Estimated Expiration
Canada 2586649 COMBINAISON D'UN INHIBITEUR DE LA SRC KINASE ET DE BCR-ABL DESTINEE AU TRAITEMENT DE MALADIES A EVOLUTION CHRONIQUE (COMBINATION OF A SRC KINASE INHIBITOR AND A BCR-ABL INHIBITOR FOR THE TREATMENT OF PROLIFERATIVE DISEASES) ⤷  Try a Trial
Norway 338049 ⤷  Try a Trial
Portugal 1711481 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for dasatinib

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1169038 92146 Luxembourg ⤷  Try a Trial PRODUCT NAME: DASATINIB ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
1169038 122013000012 Germany ⤷  Try a 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 13C0003 France ⤷  Try a Trial PRODUCT NAME: DASATINIB ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/06/363/001 20061122
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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