Orange Book product · Brand (NDA)

SPRYCEL

DASATINIB

Brand (NDA)NDA 021986TE ABRX BRISTOL MYERS SQUIBB

Jun 28, 2006

Approved

Brand (NDA)

Application

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jun 28, 2006
20 yr 3 mo ago
Exclusivity ends · ODE-225
Orphan-drug exclusivity (7 years)
Dec 21, 2025
6 mo ago
Patent 7491725 expires
Listed drug substance patent expiration.
Mar 28, 2026
3 mo ago
Today
Exclusivity ends · PED
Pediatric exclusivity (adds 6 months)
Jun 21, 2026
in 2 d
Patent 7491725*PED expires
Listed listed patent expiration.
Sep 28, 2026
in 3 mo

Active ingredient

DASATINIB

Strength

20MG

Dosage form

TABLET

Route

ORAL

TE code

Application

NDA 021986

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
7491725	Mar 28, 2026	3 mo ago	SubstanceProduct
7491725*PED	Sep 28, 2026	in 3 mo