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
International Patents: | 53 |
US Patents: | 5 |
Tradenames: | 3 |
Applicants: | 3 |
NDAs: | 4 |
Drug Master File Entries: | 14 |
Finished Product Suppliers / Packagers: | 4 |
Raw Ingredient (Bulk) Api Vendors: | 139 |
Clinical Trials: | 361 |
Patent Applications: | 6,922 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for dasatinib |
What excipients (inactive ingredients) are in dasatinib? | dasatinib excipients list |
DailyMed Link: | dasatinib at DailyMed |
Recent Clinical Trials for dasatinib
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Hospital Universitario Dr. Jose E. Gonzalez | Phase 2 |
Fernando De la Garza Salazar | Phase 2 |
Institut Paoli-Calmettes | Phase 2 |
Generic filers with tentative approvals for DASATINIB
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 80MG | TABLET;ORAL |
⤷ Sign Up | ⤷ Sign Up | 70MG | TABLET;ORAL |
⤷ Sign Up | ⤷ Sign Up | 50MG | TABLET;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
Drug Class | Kinase Inhibitor |
Mechanism of Action | Cytochrome P450 3A4 Inhibitors Protein Kinase Inhibitors |
Medical Subject Heading (MeSH) Categories for dasatinib
Anatomical Therapeutic Chemical (ATC) Classes for dasatinib
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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