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Last Updated: March 29, 2024

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 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
Innovative Therapies For Children with Cancer ConsortiumPhase 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 Trial140MGTABLET;ORAL
⤷  Try a Trial⤷  Try a Trial100MGTABLET;ORAL
⤷  Try a Trial⤷  Try a Trial80MGTABLET;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 216099-002 Dec 5, 2023 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Nanocopoeia PHYRAGO dasatinib TABLET;ORAL 216099-003 Dec 5, 2023 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Bristol Myers Squibb SPRYCEL dasatinib TABLET;ORAL 021986-001 Jun 28, 2006 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Bristol Myers Squibb SPRYCEL dasatinib TABLET;ORAL 021986-004 May 30, 2008 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Bristol Myers Squibb SPRYCEL dasatinib TABLET;ORAL 021986-001 Jun 28, 2006 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 021986-006 Oct 28, 2010 ⤷  Try a Trial ⤷  Try a Trial
Bristol Myers Squibb SPRYCEL dasatinib TABLET;ORAL 021986-005 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
Bristol Myers Squibb SPRYCEL dasatinib TABLET;ORAL 021986-002 Jun 28, 2006 ⤷  Try a Trial ⤷  Try a Trial
Bristol Myers Squibb SPRYCEL dasatinib TABLET;ORAL 021986-004 May 30, 2008 ⤷  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
Argentina 047533 PROCESO PARA PREPARAR CARBOXAMIDAS 2-AMINOTIAZOL-5-AROMATICAS COMO INHIBIDORES DE LA QUINASA ⤷  Try a Trial
India 6567DEN2014 ⤷  Try a Trial
Taiwan 200628156 Combination of a SRC kinase inhibitor and a BCR-ABL inhibitor for the treatment of proliferative diseases ⤷  Try a Trial
Israel 177280 גביש מונוהידראט של 2-אמינותיאזול-5-ארומטי קרבוקסאמידי, תהליך להכנתו, הרכב פארמצבטי שלו ושימושו להכנת תרופה (Crystalline monohydrate of a 2-aminothiazole-5-aromatic carboxamide, process for preparing same, pharmaceutical composition comprising same and use thereof for preparation of a medicament) ⤷  Try a Trial
Taiwan I338004 ⤷  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 132013902119320 Italy ⤷  Try a Trial 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
1169038 2013C/005 Belgium ⤷  Try a Trial 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 13C0003 France ⤷  Try a Trial PRODUCT NAME: DASATINIB ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/06/363/001 20061122
1169038 2013/003 Ireland ⤷  Try a Trial PRODUCT NAME: DASATINIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF.; REGISTRATION NO/DATE: EU/1/06/363/001-015 20061120
1169038 300567 Netherlands ⤷  Try a Trial PRODUCT NAME: DASATINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/06/363/001 - 009 20061120
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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