FDA Orange Book · active-ingredient family
Dasatinib
Dasatinib: 2 brands, 9 generics; first approved Jun 28, 2006; generic available.
Generic available18 exclusivity periods
Generic status & protection
Generic available: 9 ANDA applications approved.
Earliest patent expiry Latest exclusivity ends
Brands (NDA)
2
Generics (ANDA)
9
Listed patents
8
Next patent expiry
Mar 28, 2026
5 mo ago
Brand (NDA) products
Originator applications
- PHYRAGORLDHANDA THERAPNDA 21609920236 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx — 50MG TABLET ORAL Rx — 70MG TABLET ORAL Rx — 80MG TABLET ORAL Rx — 100MG TABLET ORAL Rx — 140MG TABLET ORAL Rx — - SPRYCELRLDBRISTOL MYERS SQUIBBNDA 02198620066 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 70MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB 80MG TABLET ORAL Rx AB 140MG TABLET ORAL Rx AB
Generic (ANDA) products (9)
Abbreviated applications
- DASATINIBALEMBICANDA 21626120256 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 70MG TABLET ORAL Rx AB 80MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB 140MG TABLET ORAL Rx AB - DASATINIBTEVA PHARMS USAANDA 21109420256 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 70MG TABLET ORAL Rx AB 80MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB 140MG TABLET ORAL Rx AB - DASATINIBLUPINANDA 21435020256 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 70MG TABLET ORAL Rx AB 80MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB 140MG TABLET ORAL Rx AB - DASATINIBEUGIA PHARMAANDA 21654720256 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 70MG TABLET ORAL Rx AB 80MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB 140MG TABLET ORAL Rx AB - DASATINIBBIOCON PHARMAANDA 21721720256 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 70MG TABLET ORAL Rx AB 80MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB 140MG TABLET ORAL Rx AB - DASATINIBDR REDDYSANDA 21338320256 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 70MG TABLET ORAL Rx AB 80MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB 140MG TABLET ORAL Rx AB - DASATINIBZYDUS PHARMSANDA 21871920256 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 70MG TABLET ORAL Rx AB 80MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB 140MG TABLET ORAL Rx AB - DASATINIBAPOTEXANDA 20318020212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 80MG TABLET ORAL Rx AB 140MG TABLET ORAL Rx AB - DASATINIBAPOTEXANDA 20210320164 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 20MG TABLET ORAL Rx AB 50MG TABLET ORAL Rx AB 70MG TABLET ORAL Rx AB 100MG TABLET ORAL Rx AB
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Marketing exclusivity
Hatch-Waxman
- M-307New use / labeling-change exclusivity (3 years)
in 3 mo
- M-307New use / labeling-change exclusivity (3 years)
in 3 mo
- M-307New use / labeling-change exclusivity (3 years)
in 3 mo
- M-307New use / labeling-change exclusivity (3 years)
in 3 mo
- M-307New use / labeling-change exclusivity (3 years)
in 3 mo
- M-307New use / labeling-change exclusivity (3 years)
in 3 mo
- ODE-225Orphan-drug exclusivity (7 years)
8 mo ago
- PEDPediatric exclusivity (adds 6 months)
2 mo ago
- ODE-225Orphan-drug exclusivity (7 years)
8 mo ago
- PEDPediatric exclusivity (adds 6 months)
2 mo ago
- ODE-225Orphan-drug exclusivity (7 years)
8 mo ago
- PEDPediatric exclusivity (adds 6 months)
2 mo ago
- ODE-225Orphan-drug exclusivity (7 years)
8 mo ago
- PEDPediatric exclusivity (adds 6 months)
2 mo ago
- ODE-225Orphan-drug exclusivity (7 years)
8 mo ago
- PEDPediatric exclusivity (adds 6 months)
2 mo ago
- ODE-225Orphan-drug exclusivity (7 years)
8 mo ago
- PEDPediatric exclusivity (adds 6 months)
2 mo ago
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 7491725 | 5 mo ago | SubstanceProduct | |
| 7491725*PED | in 1 mo | ||
| 12544376 | in 14 yr 8 mo | U-3767 | |
| 11324745 | in 14 yr 8 mo | U-3767 | |
| 11202778 | in 14 yr 8 mo | U-3770 | |
| 12433891 | in 14 yr 8 mo | U-3769 | |
| 12465606 | in 14 yr 8 mo | Product | |
| 11298356 | in 14 yr 8 mo | Product |
Approval history
FDA approval span
First approval
20 yr 5 mo ago
Most recent approval
10 mo ago
Approvals span 2006–2025 across 11 FDA applications.
Brand (NDA) 218%
Generic (ANDA) 982%
Dasatinib: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
