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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 two branded drugs marketed by Apotex Inc and Bristol Myers Squibb, and is included in two 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 one hundred and twenty-eight patent family members in thirty-nine countries.
There are fourteen drug master file entries for dasatinib. One supplier is listed for this compound.
Summary for dasatinib
International Patents: | 128 |
US Patents: | 5 |
Tradenames: | 2 |
Applicants: | 2 |
NDAs: | 2 |
Drug Master File Entries: | 14 |
Suppliers / Packagers: | 1 |
Bulk Api Vendors: | 117 |
Clinical Trials: | 306 |
Patent Applications: | 5,031 |
Formulation / Manufacturing: | see details |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for dasatinib |
DailyMed Link: | dasatinib at DailyMed |
Recent Clinical Trials for dasatinib
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Hoffmann-La Roche | Phase 1 |
Zhejiang University | Early Phase 1 |
Yake Biotechnology Ltd. | Early Phase 1 |
Pharmacology for dasatinib
Drug Class | Kinase Inhibitor |
Mechanism of Action | Protein Kinase Inhibitors Cytochrome P450 3A4 Inhibitors |
Medical Subject Heading (MeSH) Categories 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 | 021986-004 | May 30, 2008 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
Bristol Myers Squibb | SPRYCEL | dasatinib | TABLET;ORAL | 021986-006 | Oct 28, 2010 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
Bristol Myers Squibb | SPRYCEL | dasatinib | TABLET;ORAL | 021986-003 | Jun 28, 2006 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
Bristol Myers Squibb | SPRYCEL | dasatinib | TABLET;ORAL | 021986-006 | Oct 28, 2010 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
Bristol Myers Squibb | SPRYCEL | dasatinib | TABLET;ORAL | 021986-001 | Jun 28, 2006 | RX | Yes | No | Start Trial | Start Trial | Y | Start 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 | 021986-002 | Jun 28, 2006 | Start Trial | Start Trial |
Bristol Myers Squibb | SPRYCEL | dasatinib | TABLET;ORAL | 021986-001 | Jun 28, 2006 | Start Trial | Start Trial |
Bristol Myers Squibb | SPRYCEL | dasatinib | TABLET;ORAL | 021986-003 | Jun 28, 2006 | Start Trial | Start Trial |
Bristol Myers Squibb | SPRYCEL | dasatinib | TABLET;ORAL | 021986-006 | Oct 28, 2010 | Start Trial | Start Trial |
Bristol Myers Squibb | SPRYCEL | dasatinib | TABLET;ORAL | 021986-004 | May 30, 2008 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for dasatinib
Country | Patent Number | Estimated Expiration |
---|---|---|
Hong Kong | 1244797 | Start Trial |
New Zealand | 513639 | Start Trial |
Slovenia | 1610780 | Start Trial |
Denmark | 1711481 | Start Trial |
Portugal | 1169038 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for dasatinib
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1169038 | 92146 | Luxembourg | Start Trial | PRODUCT NAME: DASATINIB ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES |
1169038 | 6/2013 | Austria | Start Trial | PRODUCT NAME: DASATINIB UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/06/363/001-015 20061120 |
1169038 | 13C0003 | France | Start Trial | PRODUCT NAME: DASATINIB ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/06/363/001 20061122 |
1169038 | 122013000012 | Germany | Start 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 | 132013902119320 | Italy | Start 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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