Question 1

Is there a generic for Nilotinib hydrochloride?

Accepted Answer

Yes. The FDA Orange Book lists 5 approved generic (ANDA) applications for Nilotinib hydrochloride, referencing the brand TASIGNA. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

Question 2

What is the reference-listed drug for Nilotinib hydrochloride?

Accepted Answer

TASIGNA (NDA 022068, NOVARTIS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Nilotinib hydrochloride?

Accepted Answer

The Orange Book lists 12 patents against Nilotinib hydrochloride products, with the earliest listed expiry in 2026. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Question 4

Does Nilotinib hydrochloride have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 6 marketing-exclusivity periods for Nilotinib hydrochloride. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

Question 5

What dosage forms of Nilotinib hydrochloride are approved?

Accepted Answer

Nilotinib hydrochloride is approved in the following dosage form: capsule.

Product	Applicant	Application	TE	Approved
NILOTINIB HYDROCHLORIDE×2	TORRENT	ANDA 218532	AB	Dec 15, 2025
NILOTINIB HYDROCHLORIDE×3	DR REDDYS	ANDA 218350	AB	Nov 19, 2025
NILOTINIB HYDROCHLORIDE×2	HETERO LABS LTD V	ANDA 209651	AB	Nov 19, 2025
NILOTINIB HYDROCHLORIDE×3	MSN	ANDA 218544	AB	Nov 19, 2025
NILOTINIB HYDROCHLORIDE×3	APOTEX	ANDA 203640	AB	Jan 05, 2024

Patent	Expires	In	Type
8389537	Jul 18, 2026	in 29 d	U-1374
8415363	Jul 18, 2026	in 29 d	SubstanceProductU-1407
8501760	Jul 18, 2026	in 29 d	Product
8415363*PED	Jan 18, 2027	in 7 mo
8389537*PED	Jan 18, 2027	in 7 mo
8501760*PED	Jan 18, 2027	in 7 mo
8293756	Sep 25, 2027	in 1 yr 3 mo	Product
8293756*PED	Mar 25, 2028	in 1 yr 10 mo
8163904	Aug 23, 2028	in 2 yr 3 mo	SubstanceProduct
8163904*PED	Feb 23, 2029	in 2 yr 9 mo
9061029	Apr 07, 2032	in 5 yr 11 mo	SubstanceU-1374
9061029*PED	Oct 07, 2032	in 6 yr 5 mo

Nilotinib hydrochloride

Brand (NDA) products · capsule

Generic (ANDA) products (5)

Marketing exclusivity (6)

Listed patents (12)

Nilotinib hydrochloride — frequently asked questions

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