FDA Orange Book

Generic for Tasigna

Tasigna contains nilotinib. 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 Tasigna is nilotinib. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Tasigna products in the Orange Book

Tasigna products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
capsule, oral	EQ 150MG BASE	Marketed (Rx)	AB	6	AB
capsule, oral	EQ 200MG BASE	Marketed (Rx)	AB	6	AB
capsule, oral	EQ 50MG BASE	Marketed (Rx)	AB	4	AB

NDA 022068, held by NOVARTIS PHARMACEUTICALS CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic nilotinib

Approved generic versions of Tasigna
Company	ANDA	TE code	Approved	Strengths
APOTEX INC	203640	AB (A-rated, therapeutically equivalent)	January 5, 2024	EQ 150MG BASE, EQ 200MG BASE, EQ 50MG BASE
DR REDDYS LABORATORIES LTD	218350	AB (A-rated, therapeutically equivalent)	November 19, 2025	EQ 150MG BASE, EQ 200MG BASE, EQ 50MG BASE
HETERO LABS LTD UNIT V	209651	AB (A-rated, therapeutically equivalent)	November 19, 2025	EQ 150MG BASE, EQ 200MG BASE
MSN LABORATORIES PRIVATE LTD	218544	AB (A-rated, therapeutically equivalent)	November 19, 2025	EQ 150MG BASE, EQ 200MG BASE, EQ 50MG BASE
TORRENT PHARMACEUTICALS LTD	218532	AB (A-rated, therapeutically equivalent)	December 15, 2025	EQ 150MG BASE, EQ 200MG BASE
TEVA PHARMACEUTICALS INC	219134	AB (A-rated, therapeutically equivalent)	June 26, 2026	EQ 150MG BASE, EQ 200MG BASE, EQ 50MG BASE

Tasigna patents

Patents listed for Tasigna
Patent	Expires	Covers	Use code	NDA
8389537	July 18, 2026	Method of use	U-1374	022068
8415363	July 18, 2026	Drug substance, Drug product	U-1407	022068
8415363	July 18, 2026	Drug substance, Drug product	U-1374	022068
8501760	July 18, 2026	Drug product	None	022068
8415363*PED	January 18, 2027	Method of use	None	022068
8389537*PED	January 18, 2027	Method of use	None	022068
8501760*PED	January 18, 2027	Method of use	None	022068
8293756	September 25, 2027	Drug product	None	022068
8293756*PED	March 25, 2028	Method of use	None	022068
8163904	August 23, 2028	Drug substance, Drug product	None	022068
8163904*PED	February 23, 2029	Method of use	None	022068
9061029	April 7, 2032	Drug substance	U-1374	022068
9061029	April 7, 2032	Drug substance	U-3231	022068
9061029*PED	October 7, 2032	Method of use	None	022068

Tasigna exclusivity

Exclusivity listed for Tasigna
Code	Meaning	Expires	NDA
ODE-380	Orphan drug exclusivity	September 23, 2028	022068
PED	Pediatric exclusivity	March 23, 2029	022068

Tasigna NDC codes

Questions

Is there a generic for Tasigna?

Yes. The generic name for Tasigna is nilotinib. 6 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 Tasigna?

The active ingredient in Tasigna is nilotinib, per the FDA Orange Book.

When does the Tasigna patent expire?

The last patent listed for Tasigna in the Orange Book expires October 7, 2032. 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.