FDA Orange Book

Generic for Sprycel

Sprycel contains dasatinib. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.

Source: FDA Orange Book data file dated 2026-10-09. Publisher page

Yes. The generic name for Sprycel is dasatinib. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

Run it in Rivvi

Map Sprycel and your other top fills to their generics

Every strength in RxNorm, with brands that have no generic flagged.

Build the map

Free to start. Opens Rivvi, the AI workspace for healthcare teams.

Sprycel products in the Orange Book

Sprycel products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
tablet, oral	100MG	Marketed (Rx)	AB	9	AB
tablet, oral	140MG	Marketed (Rx)	AB	9	AB
tablet, oral	20MG	Marketed (Rx)	AB	9	AB
tablet, oral	50MG	Marketed (Rx)	AB	9	AB
tablet, oral	70MG	Marketed (Rx)	AB	9	AB
tablet, oral	80MG	Marketed (Rx)	AB	9	AB

NDA 021986, held by BRISTOL MYERS SQUIBB CO. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic dasatinib

Approved generic versions of Sprycel
Company	ANDA	TE code	Approved	Strengths
APOTEX INC	202103	AB (A-rated, therapeutically equivalent)	June 10, 2016	100MG, 20MG, 50MG, 70MG
APOTEX INC	203180	AB (A-rated, therapeutically equivalent)	November 23, 2021	140MG, 80MG
BIOCON PHARMA LTD	217217	AB (A-rated, therapeutically equivalent)	March 3, 2025	100MG, 140MG, 20MG, 50MG, 70MG, 80MG
DR REDDYS LABORATORIES LTD	213383	AB (A-rated, therapeutically equivalent)	March 3, 2025	100MG, 140MG, 20MG, 50MG, 70MG, 80MG
ZYDUS PHARMACEUTICALS USA INC	218719	AB (A-rated, therapeutically equivalent)	March 3, 2025	100MG, 140MG, 20MG, 50MG, 70MG, 80MG
EUGIA PHARMA SPECIALITIES LTD	216547	AB (A-rated, therapeutically equivalent)	April 22, 2025	100MG, 140MG, 20MG, 50MG, 70MG, 80MG
LUPIN INC	214350	AB (A-rated, therapeutically equivalent)	August 25, 2025	100MG, 140MG, 20MG, 50MG, 70MG, 80MG
TEVA PHARMACEUTICALS USA INC	211094	AB (A-rated, therapeutically equivalent)	August 27, 2025	100MG, 140MG, 20MG, 50MG, 70MG, 80MG
ALEMBIC PHARMACEUTICALS LTD	216261	AB (A-rated, therapeutically equivalent)	November 6, 2025	100MG, 140MG, 20MG, 50MG, 70MG, 80MG
MSN LABORATORIES PRIVATE LTD	219579	AB (A-rated, therapeutically equivalent)	September 11, 2026	100MG, 140MG, 20MG, 50MG, 70MG, 80MG

Sprycel patents

Patents listed for Sprycel
Patent	Expires	Covers	Use code	NDA
7491725	March 28, 2026	Drug substance, Drug product	None	021986
7491725*PED	September 28, 2026	Method of use	None	021986

Sprycel exclusivity

Exclusivity listed for Sprycel
Code	Meaning	Expires	NDA
ODE-225	Orphan drug exclusivity	December 21, 2025	021986
PED	Pediatric exclusivity	June 21, 2026	021986

Sprycel NDC codes

Questions

Is there a generic for Sprycel?

Yes. The generic name for Sprycel is dasatinib. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

What is the generic name for Sprycel?

The active ingredient in Sprycel is dasatinib, per the FDA Orange Book.

When does the Sprycel patent expire?

The last patent listed for Sprycel in the Orange Book expires September 28, 2026. A listed patent expiry date is not a generic launch date.

What does a therapeutic equivalence code mean?

In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.