dasatinib · Bristol Myers Squibb · NDA 021986
Sprycel
Earliest generic entry, as listed · earliest of 6 marketed strengths
Open now
No unexpired patents or exclusivities are listed for this product.
Listed patents · 0 unexpired
No unexpired patents listed.
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
- 25 Oct 2026Generic approved · 021986-00111 Sep 2026
Products covered · 6
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 021986 · 001 · RLD | tablet, oral | 20MG | open |
| 021986 · 002 · RLD | tablet, oral | 50MG | open |
| 021986 · 003 · RLD | tablet, oral | 70MG | open |
| 021986 · 004 · RLD | tablet, oral | 100MG | open |
| 021986 · 005 · RLD | tablet, oral | 80MG | open |
| 021986 · 006 · RLD | tablet, oral | 140MG | open |
Expired or delisted (4)
- US 7491725 · — · 28 Sep 2026
- US 7491725 · substance, product · 28 Mar 2026
- PED · 21 Jun 2026
- ODE-225 · 21 Dec 2025