Dasatinib - Generic Drug Details
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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, Biocon Pharma, Dr Reddys, Eugia Pharma, Zydus Pharms, Handa Therap, and Bristol Myers Squibb, and is included in eight 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. Nine 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: | 7 |
NDAs: | 8 |
Drug Master File Entries: | 14 |
Finished Product Suppliers / Packagers: | 9 |
Raw Ingredient (Bulk) Api Vendors: | 139 |
Clinical Trials: | 361 |
Patent Applications: | 6,263 |
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 |
⤷ Try for Free | ⤷ Try for Free | 140MG | TABLET;ORAL |
⤷ Try for Free | ⤷ Try for Free | 100MG | TABLET;ORAL |
⤷ Try for Free | ⤷ Try for Free | 80MG | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Eugia Pharma | DASATINIB | dasatinib | TABLET;ORAL | 216547-003 | Apr 22, 2025 | AB | RX | No | No | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | |||
Bristol Myers Squibb | SPRYCEL | dasatinib | TABLET;ORAL | 021986-001 | Jun 28, 2006 | AB | RX | Yes | No | ⤷ Try for Free | ⤷ Try for Free | Y | ⤷ Try for Free | ||
Zydus Pharms | DASATINIB | dasatinib | TABLET;ORAL | 218719-001 | Mar 3, 2025 | AB | RX | No | No | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | |||
Zydus Pharms | DASATINIB | dasatinib | TABLET;ORAL | 218719-006 | Mar 3, 2025 | AB | RX | No | No | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | |||
>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 | 021986-005 | Oct 28, 2010 | ⤷ Try for Free | ⤷ Try for Free |
Bristol Myers Squibb | SPRYCEL | dasatinib | TABLET;ORAL | 021986-002 | Jun 28, 2006 | ⤷ Try for Free | ⤷ Try for Free |
Bristol Myers Squibb | SPRYCEL | dasatinib | TABLET;ORAL | 021986-006 | Oct 28, 2010 | ⤷ Try for Free | ⤷ Try for Free |
Bristol Myers Squibb | SPRYCEL | dasatinib | TABLET;ORAL | 021986-005 | Oct 28, 2010 | ⤷ Try for Free | ⤷ Try for Free |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for dasatinib
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
European Patent Office | 1812432 | 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 for Free |
Austria | E453630 | ⤷ Try for Free | |
South Africa | 200606242 | PROCESS FOR PREPARING 2-AMINOTHIAZOLE-5-AROMATIC CARBOXAMIDES AS KINASE INHIBITORS | ⤷ Try for Free |
Brazil | PI0507476 | processo para preparação de 2-aminotiazol-5-carboxamidas aromáticas como inibidores de cinase | ⤷ Try for Free |
>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 for Free | PRODUCT NAME: DASATINIB ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES |
1169038 | 2013/003 | Ireland | ⤷ Try for Free | PRODUCT NAME: DASATINIB AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF.; REGISTRATION NO/DATE: EU/1/06/363/001-015 20061120 |
1169038 | CA 2013 00006 | Denmark | ⤷ Try for Free | PRODUCT NAME: DASATINIB OG FARMACEUTISK ACCEPTABLE SALTE DERAF, HERUNDER MONOHYDRATET; REG. NO/DATE: EU/1/06/363/001-015 20061122 |
1169038 | C300567 | Netherlands | ⤷ Try for Free | 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 |
Market Dynamics and Financial Trajectory for Dasatinib
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