Is there a generic for Nilotinib d-tartrate?

The FDA Orange Book does not currently list an approved generic (ANDA) for Nilotinib d-tartrate. It is available as 1 brand (NDA) application.

What is the reference-listed drug for Nilotinib d-tartrate?

NILOTINIB D-TARTRATE (NDA 218922, CIPLA) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Nilotinib d-tartrate are approved?

Nilotinib d-tartrate is approved in the following dosage form: capsule.

FDA Orange Book · active-ingredient family

Nilotinib d-tartrate

Nilotinib d-tartrate is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:NILOTINIB D-TARTRATE · NDA 218922

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · capsule

Product	Applicant	Application	TE	Approved
NILOTINIB D-TARTRATERLD×3	CIPLA	NDA 218922	—	Feb 19, 2025

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Nilotinib d-tartrate — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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