TASIGNA Drug Patent Profile

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 two Paragraph IV challenges.

This drug has two hundred and seventy-six 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.

DrugPatentWatch^® 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 are two Paragraph IV patent challenges for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for TASIGNA

International Patents:	276
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	123
Clinical Trials:	64
Patent Applications:	4,436
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for TASIGNA
What excipients (inactive ingredients) are in TASIGNA?	TASIGNA excipients list
DailyMed Link:	TASIGNA at DailyMed

See drug prices for TASIGNA

DrugPatentWatch^® Estimated 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
Kartos Therapeutics, Inc.	Phase 1/Phase 2
Baylor College of Medicine	Phase 2
Ohio State University Comprehensive Cancer Center	Phase 1

See all TASIGNA clinical trials

Pharmacology for TASIGNA

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 TASIGNA

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

Paragraph IV (Patent) Challenges for TASIGNA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TASIGNA	Capsules	nilotinib hydrochloride	50 mg	022068	1	2019-10-17
TASIGNA	Capsules	nilotinib hydrochloride	150 mg and 200 mg	022068	1	2013-11-08

US Patents and Regulatory Information for TASIGNA

TASIGNA is protected by seven US patents and five FDA Regulatory Exclusivities.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting TASIGNA

FDA Regulatory Exclusivity protecting 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					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	022068-001	Oct 29, 2007		RX	Yes	Yes					Y

International Patents for TASIGNA

When does loss-of-exclusivity occur for TASIGNA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Croatia

Cyprus

Denmark

Ecuador

European Patent Office

Guatemala

Hong Kong

Hungary

Israel

Japan

Jordan

Malaysia

Mexico

Montenegro

Morocco

New Zealand

Peru

Poland

Russian Federation

San Marino

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Tunisia

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering TASIGNA around the world.

Country	Patent Number	Title	Estimated Expiration
China	101228151	Salts of 4-methyl-N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyridin-3-yl-pyrimidine-2-ylamino)-benzamide
Mexico	2012005694	METODO PARA EL TRATAMIENTO DE TRANSTORNOS PROLIFERATIVOS Y OTRAS CONDICIONES PATOLOGICAS MEDIADAS POR LA ACTIVIDAD DE CINASA DE CBR-ABL, C-KIT, DDR1, DDR2 O PDGF-R. (METHOD OF TREATING PROLIFERATIVE DISORDERS AND OTHER PATHOLOGICAL CONDITIONS MEDIATED BY BCR-ABL, C-KIT, DDR1, DDR2 OR PDGF-R KINASE ACTIVITY.)
Cyprus	1117519
Eurasian Patent Organization	201000145	КРИСТАЛЛИЧЕСКИЕ ФОРМЫ 4-МЕТИЛ-N-[3-(4-МЕТИЛИМИДАЗОЛ-1-ИЛ)-5-ТРИФТОРМЕТИЛФЕНИЛ]-3-(4-ПИРИДИН-3-ИЛПИРИМИДИН-2-ИЛАМИНО)БЕНЗАМИДА