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TASIGNA Drug Profile

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When do Tasigna patents expire, and what generic alternatives are available?

Tasigna is a drug marketed by Novartis and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and seventy-two patent family members in fifty-one countries.

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

US ANDA Litigation and Generic Entry Outlook for Tasigna

Tasigna was eligible for patent challenges on October 29, 2011.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 7, 2032. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for TASIGNA

International Patents:	272
US Patents:	7
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	113
Clinical Trials:	58
Patent Applications:	4,513
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for TASIGNA
DailyMed Link:	TASIGNA at DailyMed

See drug prices for TASIGNA

Generic Entry Opportunity Date for TASIGNA

NDA:

022068

Dosage:

CAPSULE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for TASIGNA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Ohio State University Comprehensive Cancer Center	Phase 1
National Institutes of Health (NIH)	Phase 2
Plateforme labellisée Inca – Hôpital Européen Georges Pompidou, Paris	Phase 3

See all TASIGNA clinical trials

Pharmacology for TASIGNA

Drug Class	Kinase Inhibitor
Mechanism of Action	Protein Kinase Inhibitors

Paragraph IV (Patent) Challenges for TASIGNA

Tradename	Dosage	Ingredient	NDA	Submissiondate
TASIGNA	CAPSULE;ORAL	nilotinib hydrochloride	022068	2019-10-17
TASIGNA	CAPSULE;ORAL	nilotinib hydrochloride	022068	2013-11-08

US Patents and Regulatory Information for TASIGNA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	TASIGNA	nilotinib hydrochloride	CAPSULE;ORAL	022068-001	Oct 29, 2007		RX	Yes	Yes
Novartis	TASIGNA	nilotinib hydrochloride	CAPSULE;ORAL	022068-001	Oct 29, 2007		RX	Yes	Yes					Y
Novartis	TASIGNA	nilotinib hydrochloride	CAPSULE;ORAL	022068-001	Oct 29, 2007		RX	Yes	Yes					Y
Novartis	TASIGNA	nilotinib hydrochloride	CAPSULE;ORAL	022068-001	Oct 29, 2007		RX	Yes	Yes					Y
Novartis	TASIGNA	nilotinib hydrochloride	CAPSULE;ORAL	022068-003	Mar 22, 2018		RX	Yes	No					Y
Novartis	TASIGNA	nilotinib hydrochloride	CAPSULE;ORAL	022068-002	Jun 17, 2010		RX	Yes	No					Y
Novartis	TASIGNA	nilotinib hydrochloride	CAPSULE;ORAL	022068-002	Jun 17, 2010		RX	Yes	No

International Patents for TASIGNA

Country	Patent Number	Estimated Expiration
Russian Federation	2013101749
Chile	2007002766
Austria	414699
Australia	2010241419
European Patent Office	2284168
Canada	2677315
Tunisia	SN08028