DASATINIB Drug Patent Profile
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Which patents cover Dasatinib, and when can generic versions of Dasatinib launch?
Dasatinib is a drug marketed by Apotex and is included in two NDAs.
The generic ingredient in DASATINIB is dasatinib. There are fourteen drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the dasatinib profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Dasatinib
A generic version of DASATINIB was approved as dasatinib by APOTEX on June 10th, 2016.
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Summary for DASATINIB
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 139 |
| Clinical Trials: | 361 |
| Patent Applications: | 4,294 |
| 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 |
|---|---|
| Fernando De la Garza Salazar | Phase 2 |
| Hospital Universitario Dr. Jose E. Gonzalez | Phase 2 |
| Institut Paoli-Calmettes | Phase 2 |
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
DASATINIB is protected by zero US patents and one FDA Regulatory Exclusivity.
FDA Regulatory Exclusivity protecting DASATINIB
PATENT CHALLENGE
Exclusivity Expiration: ⤷ Sign Up
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Apotex | DASATINIB | dasatinib | TABLET;ORAL | 202103-001 | Jun 10, 2016 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Apotex | DASATINIB | dasatinib | TABLET;ORAL | 203180-001 | Nov 23, 2021 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Apotex | DASATINIB | dasatinib | TABLET;ORAL | 202103-002 | Jun 10, 2016 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Apotex | DASATINIB | dasatinib | TABLET;ORAL | 202103-003 | Jun 10, 2016 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Apotex | DASATINIB | dasatinib | TABLET;ORAL | 203180-002 | Nov 23, 2021 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
