Last Updated: August 10, 2026

NILOTINIB Drug Patent Profile

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Which patents cover Nilotinib, and when can generic versions of Nilotinib launch?

Nilotinib is a drug marketed by Cipla, Apotex, Dr Reddys, Hetero Labs Ltd V, MSN, Teva Pharms Inc, and Torrent. and is included in seven NDAs.

The generic ingredient in NILOTINIB is nilotinib hydrochloride. There are eleven drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the nilotinib hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Nilotinib

A generic version of NILOTINIB was approved as nilotinib hydrochloride by APOTEX on January 5^th, 2024.

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Summary for NILOTINIB

US Patents:	0
Applicants:	7
NDAs:	7
What excipients (inactive ingredients) are in NILOTINIB?	NILOTINIB excipients list
DailyMed Link:	NILOTINIB at DailyMed

Drug patent expirations by year for NILOTINIB

Recent Clinical Trials for NILOTINIB

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Sponsor	Phase
United States Department of Defense	PHASE1
Medical University of South Carolina	PHASE1
Columbia University	PHASE1

See all NILOTINIB clinical trials

Pharmacology for NILOTINIB

Drug Class	Kinase Inhibitor
Mechanism of Action	Bcr-Abl Tyrosine Kinase Inhibitors Cytochrome P450 2B6 Inducers Cytochrome P450 2C8 Inducers Cytochrome P450 2C8 Inhibitors Cytochrome P450 2D6 Inhibitors P-Glycoprotein Inhibitors UGT1A1 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for NILOTINIB

L01EA	BCR-ABL tyrosine kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for NILOTINIB

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cipla	NILOTINIB D-TARTRATE	nilotinib d-tartrate	CAPSULE;ORAL	218922-001	Feb 19, 2025		RX	Yes	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Torrent	NILOTINIB HYDROCHLORIDE	nilotinib hydrochloride	CAPSULE;ORAL	218532-001	Dec 15, 2025	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Dr Reddys	NILOTINIB HYDROCHLORIDE	nilotinib hydrochloride	CAPSULE;ORAL	218350-001	Nov 19, 2025	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Apotex	NILOTINIB HYDROCHLORIDE	nilotinib hydrochloride	CAPSULE;ORAL	203640-001	Jan 5, 2024	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Msn	NILOTINIB HYDROCHLORIDE	nilotinib hydrochloride	CAPSULE;ORAL	218544-001	Nov 19, 2025	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Dr Reddys	NILOTINIB HYDROCHLORIDE	nilotinib hydrochloride	CAPSULE;ORAL	218350-002	Nov 19, 2025	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

DrugChatter Q&A for NILOTINIB

Nilotinib api manufacturers?
Apotex novartis nilotinib?
Nilotinib tasigna supplier?
Nilotinib patent expiration date?
Nilotinib patent expiry date?

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