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Last Updated: May 28, 2022

TASIGNA Drug Patent 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 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

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Summary for TASIGNA
Drug patent expirations by year for TASIGNA
Drug Prices for TASIGNA

See drug prices for TASIGNA

DrugPatentWatch® Estimated Generic Entry Opportunity Date for TASIGNA
Generic Entry Date for TASIGNA*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
Kartos Therapeutics, Inc.Phase 1/Phase 2
Baylor College of MedicinePhase 2
Ohio State University Comprehensive Cancer CenterPhase 1

See all TASIGNA clinical trials

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.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of TASIGNA is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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

Inhibitors of tyrosine kinases
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Salts of 4-methyl-N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-- 3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-Benzamide
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Pharmaceutical compositions comprising nilotinib hydrochloride monohydrate
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Salts of 4-methyl N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyridin-3-yl- -pyrimidin-2-ylamino)-benzamide
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Crystalline forms of 4-methyl-N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyr- idin-3-yl-pyrimidin-2-ylamino)-benzamide
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Pharmaceutical compositions comprising nilotinib or its salt
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Method of treating proliferative disorders and other pathological conditions mediated by Bcr-Abl, c-Kit, DDR1, DDR2 or PDGF-R kinase activity
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting TASIGNA

TREATMENT OF PEDIATRIC PATIENTS GREATER THAN OR EQUAL TO 1 YEAR OF AGE WITH NEWLY DIAGNOSED PHILADELPHIA CHROMOSOME POSITIVE CHRONIC MYELOID LEUKEMIA (PH+CML) IN CHRONIC PHASE
Exclusivity Expiration: See Plans and Pricing

TREATMENT OF PEDIATRIC PATIENTS GREATER THAN OR EQUAL TO 1 YEAR OF AGE WITH CHRONIC PHASE PHILADELPHIA CHROMOSOME POSITIVE CHRONIC MYELOID LEUKEMIA WITH RESISTANCE OR INTOLERANCE TO PRIOR TYROSINE-KINASE INHIBITOR THERAPY
Exclusivity Expiration: See Plans and Pricing

TREATMENT OF PEDIATRIC PATIENTS GREATER THAN OR EQUAL TO 1 YEAR OF AGE WITH ACCELERATED PHASE PHILADELPHIA CHROMOSOME POSITIVE CHRONIC MYELOID LEUKEMIA (PH+ CML) WITH RESISTANCE ORINTOLERANCE TO PRIOR TYROSINE-KINASE INHIBITOR (TKI) THERAPY
Exclusivity Expiration: See Plans and Pricing

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: See Plans and Pricing

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Novartis TASIGNA nilotinib hydrochloride CAPSULE;ORAL 022068-001 Oct 29, 2007 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Novartis TASIGNA nilotinib hydrochloride CAPSULE;ORAL 022068-001 Oct 29, 2007 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Novartis TASIGNA nilotinib hydrochloride CAPSULE;ORAL 022068-001 Oct 29, 2007 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

Patent: 9029
Estimated Expiration: See Plans and Pricing

Australia

Patent: 10322102
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2012011693
Estimated Expiration: See Plans and Pricing

Canada

Patent: 79490
Estimated Expiration: See Plans and Pricing

Chile

Patent: 12001270
Estimated Expiration: See Plans and Pricing

China

Patent: 2612368
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 51690
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0160472
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 17519
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 01384
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 12011903
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 01384
Estimated Expiration: See Plans and Pricing

Guatemala

Patent: 1200150
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 69950
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 27307
Estimated Expiration: See Plans and Pricing

Israel

Patent: 9727
Estimated Expiration: See Plans and Pricing

Japan

Patent: 29615
Estimated Expiration: See Plans and Pricing

Patent: 13511524
Estimated Expiration: See Plans and Pricing

Patent: 15180636
Estimated Expiration: See Plans and Pricing

Jordan

Patent: 34
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 9956
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 12005694
Estimated Expiration: See Plans and Pricing

Montenegro

Patent: 413
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 738
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 9968
Estimated Expiration: See Plans and Pricing

Peru

Patent: 121476
Estimated Expiration: See Plans and Pricing

Poland

Patent: 01384
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 25835
Estimated Expiration: See Plans and Pricing

Patent: 12124811
Estimated Expiration: See Plans and Pricing

San Marino

Patent: 01600143
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 747
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 201501169V
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 01384
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1203328
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1743315
Estimated Expiration: See Plans and Pricing

Patent: 120102635
Estimated Expiration: See Plans and Pricing

Spain

Patent: 72128
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 98116
Estimated Expiration: See Plans and Pricing

Patent: 1141481
Estimated Expiration: See Plans and Pricing

Tunisia

Patent: 12000206
Estimated Expiration: See Plans and Pricing

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 See Plans and Pricing
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.) See Plans and Pricing
Cyprus 1117519 See Plans and Pricing
Eurasian Patent Organization 201000145 КРИСТАЛЛИЧЕСКИЕ ФОРМЫ 4-МЕТИЛ-N-[3-(4-МЕТИЛИМИДАЗОЛ-1-ИЛ)-5-ТРИФТОРМЕТИЛФЕНИЛ]-3-(4-ПИРИДИН-3-ИЛПИРИМИДИН-2-ИЛАМИНО)БЕНЗАМИДА See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
McKesson
Merck
Medtronic
Baxter
Harvard Business School

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.