FDA Orange Book · active-ingredient family
Dasatinib
Dasatinib is approved as 2 brand and 9 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:PHYRAGO · NDA 216099
2
Brand (NDA)
9
Generics (ANDA)
8
Listed patents
18
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PHYRAGORLD×6 | HANDA THERAP | NDA 216099 | — | Dec 05, 2023 | |
| SPRYCELRLD×6 | BRISTOL MYERS SQUIBB | NDA 021986 | AB | Jun 28, 2006 |
Generic (ANDA) products (9)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DASATINIB×6 | ALEMBIC | ANDA 216261 | AB | Nov 06, 2025 | |
| DASATINIB×6 | TEVA PHARMS USA | ANDA 211094 | AB | Aug 27, 2025 | |
| DASATINIB×6 | LUPIN | ANDA 214350 | AB | Aug 25, 2025 | |
| DASATINIB×6 | EUGIA PHARMA | ANDA 216547 | AB | Apr 22, 2025 | |
| DASATINIB×6 | BIOCON PHARMA | ANDA 217217 | AB | Mar 03, 2025 | |
| DASATINIB×6 | DR REDDYS | ANDA 213383 | AB | Mar 03, 2025 | |
| DASATINIB×6 | ZYDUS PHARMS | ANDA 218719 | AB | Mar 03, 2025 | |
| DASATINIB×2 | APOTEX | ANDA 203180 | AB | Nov 23, 2021 | |
| DASATINIB×4 | APOTEX | ANDA 202103 | AB | Jun 10, 2016 |
Marketing exclusivity (18)
- M-307New use / labeling-change exclusivity (3 years)
Dec 05, 2026
in 6 mo
- M-307New use / labeling-change exclusivity (3 years)
Dec 05, 2026
in 6 mo
- M-307New use / labeling-change exclusivity (3 years)
Dec 05, 2026
in 6 mo
- M-307New use / labeling-change exclusivity (3 years)
Dec 05, 2026
in 6 mo
- M-307New use / labeling-change exclusivity (3 years)
Dec 05, 2026
in 6 mo
- M-307New use / labeling-change exclusivity (3 years)
Dec 05, 2026
in 6 mo
- ODE-225Orphan-drug exclusivity (7 years)
Dec 21, 2025
6 mo ago
- PEDPediatric exclusivity (adds 6 months)
Jun 21, 2026
in 2 d
- ODE-225Orphan-drug exclusivity (7 years)
Dec 21, 2025
6 mo ago
- PEDPediatric exclusivity (adds 6 months)
Jun 21, 2026
in 2 d
- ODE-225Orphan-drug exclusivity (7 years)
Dec 21, 2025
6 mo ago
- PEDPediatric exclusivity (adds 6 months)
Jun 21, 2026
in 2 d
- ODE-225Orphan-drug exclusivity (7 years)
Dec 21, 2025
6 mo ago
- PEDPediatric exclusivity (adds 6 months)
Jun 21, 2026
in 2 d
- ODE-225Orphan-drug exclusivity (7 years)
Dec 21, 2025
6 mo ago
- PEDPediatric exclusivity (adds 6 months)
Jun 21, 2026
in 2 d
- ODE-225Orphan-drug exclusivity (7 years)
Dec 21, 2025
6 mo ago
- PEDPediatric exclusivity (adds 6 months)
Jun 21, 2026
in 2 d
Listed patents (8)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7491725 | Mar 28, 2026 | 3 mo ago | SubstanceProduct |
| 7491725*PED | Sep 28, 2026 | in 3 mo | |
| 12544376 | Jan 22, 2041 | in 14 yr 10 mo | U-3767 |
| 11324745 | Jan 22, 2041 | in 14 yr 10 mo | U-3767 |
| 11202778 | Jan 22, 2041 | in 14 yr 10 mo | U-3770 |
| 12433891 | Jan 22, 2041 | in 14 yr 10 mo | U-3769 |
| 12465606 | Jan 22, 2041 | in 14 yr 10 mo | Product |
| 11298356 | Jan 22, 2041 | in 14 yr 10 mo | Product |
Dasatinib — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
