You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 28, 2024

Dasatinib - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


What are the generic 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. 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
Fernando De la Garza SalazarPhase 2
Hospital Universitario Dr. Jose E. GonzalezPhase 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 Trial100MGTABLET;ORAL
⤷  Try a Trial⤷  Try a Trial80MGTABLET;ORAL
⤷  Try a Trial⤷  Try a Trial70MGTABLET;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 021986-006 Oct 28, 2010 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bristol Myers Squibb SPRYCEL dasatinib TABLET;ORAL 021986-004 May 30, 2008 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bristol Myers Squibb SPRYCEL dasatinib TABLET;ORAL 021986-001 Jun 28, 2006 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Nanocopoeia PHYRAGO dasatinib TABLET;ORAL 216099-004 Dec 5, 2023 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Nanocopoeia PHYRAGO dasatinib TABLET;ORAL 216099-002 Dec 5, 2023 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
World Intellectual Property Organization (WIPO) 2006052810 ⤷  Try a Trial
Japan 2008519049 ⤷  Try a Trial
Brazil PI0515721 uso de um inibidor de src cinase e um inibidor de bcr-abl, composição farmacêutica e combinação ⤷  Try a Trial
Argentina 053984 COMBINACION DE UN INHIBIDOR DE PROTEINA CINASA SRC Y UN INHIBIDOR BCR - ABL PARA EL TRATAMIENTO DE ENFERMEDADES PROLIFERATIVAS ⤷  Try a Trial
Russian Federation 2382039 СПОСОБ ПОЛУЧЕНИЯ 2-АМИНОТИАЗОЛ-5-АРОМАТИЧЕСКИХ КАРБОКСАМИДОВ В КАЧЕСТВЕ ИНГИБИТОРОВ КИНАЗ (METHOD OF PRODUCING 2-AMINOTHIAZOLE-5-AROMATIC CARBOXAMIDES AS KINASE INHIBITORS) ⤷  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 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
1169038 CA 2013 00006 Denmark ⤷  Try a Trial PRODUCT NAME: DASATINIB OG FARMACEUTISK ACCEPTABLE SALTE DERAF, HERUNDER MONOHYDRATET; REG. NO/DATE: EU/1/06/363/001-015 20061122
1169038 C300567 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
1169038 1390004-8 Sweden ⤷  Try a Trial PRODUCT NAME: DASATINIB OCH FARMACEUTISKT GODTAGBARA SALTER DAERAV; REG. NO/DATE: EU/1/06/363/001 20061120
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.