You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: May 23, 2024

TASIGNA Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


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 ninety patent family members in fifty-two 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® Litigation and Generic Entry Outlook for Tasigna

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

  Sign Up

Drug patent expirations by year for TASIGNA
Drug Prices for TASIGNA

See drug prices for TASIGNA

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.

Patents protecting TASIGNA

Inhibitors of tyrosine kinases
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Pharmaceutical compositions comprising nilotinib hydrochloride monohydrate
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Pharmaceutical compositions comprising nilotinib or its salt
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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

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: ⤷  Sign Up

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: ⤷  Sign Up

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 OR INTOLERANCE TO PRIOR TYROSINE-KINASE INHIBITOR (TKI) THERAPY
Exclusivity Expiration: ⤷  Sign Up

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷  Sign Up

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷  Sign Up

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

Expired US Patents for TASIGNA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis TASIGNA nilotinib hydrochloride CAPSULE;ORAL 022068-003 Mar 22, 2018 ⤷  Sign Up ⤷  Sign Up
Novartis TASIGNA nilotinib hydrochloride CAPSULE;ORAL 022068-002 Jun 17, 2010 ⤷  Sign Up ⤷  Sign Up
Novartis TASIGNA nilotinib hydrochloride CAPSULE;ORAL 022068-001 Oct 29, 2007 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent 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: ⤷  Sign Up

Australia

Patent: 10322102
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 2012011693
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 79490
Estimated Expiration: ⤷  Sign Up

Chile

Patent: 12001270
Estimated Expiration: ⤷  Sign Up

China

Patent: 2612368
Estimated Expiration: ⤷  Sign Up

Colombia

Patent: 51690
Estimated Expiration: ⤷  Sign Up

Croatia

Patent: 0160472
Estimated Expiration: ⤷  Sign Up

Cyprus

Patent: 17519
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 01384
Estimated Expiration: ⤷  Sign Up

Ecuador

Patent: 12011903
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 01384
Estimated Expiration: ⤷  Sign Up

Finland

Patent: 01384
Estimated Expiration: ⤷  Sign Up

Guatemala

Patent: 1200150
Estimated Expiration: ⤷  Sign Up

Hong Kong

Patent: 69950
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 27307
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 9727
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 29615
Estimated Expiration: ⤷  Sign Up

Patent: 13511524
Estimated Expiration: ⤷  Sign Up

Patent: 15180636
Estimated Expiration: ⤷  Sign Up

Jordan

Patent: 34
Estimated Expiration: ⤷  Sign Up

Malaysia

Patent: 9956
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 12005694
Estimated Expiration: ⤷  Sign Up

Montenegro

Patent: 413
Estimated Expiration: ⤷  Sign Up

Morocco

Patent: 738
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 9968
Estimated Expiration: ⤷  Sign Up

Peru

Patent: 121476
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 01384
Estimated Expiration: ⤷  Sign Up

Russian Federation

Patent: 25835
Estimated Expiration: ⤷  Sign Up

Patent: 12124811
Estimated Expiration: ⤷  Sign Up

San Marino

Patent: 01600143
Estimated Expiration: ⤷  Sign Up

Serbia

Patent: 747
Estimated Expiration: ⤷  Sign Up

Singapore

Patent: 201501169V
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 01384
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 1203328
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 1743315
Estimated Expiration: ⤷  Sign Up

Patent: 120102635
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 72128
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 98116
Estimated Expiration: ⤷  Sign Up

Patent: 1141481
Estimated Expiration: ⤷  Sign Up

Tunisia

Patent: 12000206
Estimated Expiration: ⤷  Sign Up

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
Norway 20091501 ⤷  Sign Up
Jordan 2757 املاح احادي هيدرات احادي هيدروكلوريد 4-ميثيل-ان-(3-(4-ميثيل-ايميدازول-1-يل)-5-ثلاثي فلورو-فنيل)-3-(4-بيريدين-3-يل-بيريميدين-2-يل أمينو)-بنزاميد (MONOHYDROCHLORIDE MONOHYDRATE SALT OF 4-METHYL-N-(3-(4-METHYL-IMIDAZOL-1-YL)-5-TRIFLUOROMETHYL-PHENYL]-3-(4-PYRIDIN-3-YL-PYRIMIDIN-2-YLAMINO)-BENZAMIDE) ⤷  Sign Up
European Patent Office 2501384 MÉTHODE DE TRAITEMENT DE TROUBLES PROLIFÉRATIFS ET D'AUTRES AFFECTIONS PATHOLOGIQUES MÉDIÉS PAR BCR-ABL, C-KIT, DDR1, DDR2 OU L'ACTIVITÉ KINASE DU PDGF-R (METHOD OF TREATING PROLIFERATIVE DISORDERS AND OTHER PATHOLOGICAL CONDITIONS MEDIATED BY BCR-ABL, C-KIT, DDR1, DDR2 OR PDGF-R KINASE ACTIVITY) ⤷  Sign Up
Taiwan 201418244 Pharmaceutical compositions ⤷  Sign Up
South Korea 20080027855 SALTS OF 4-METHYL-N-[3-(4-METHYL-IMIDAZOL-1-YL)-5-TRIFLUOROMETHYL-PHENYL]-3-(4-PYRIDIN-3-YL-PYRIMIDIN-2-YLAMINO)-BENZAMIDE ⤷  Sign Up
Eurasian Patent Organization 016856 КРИСТАЛЛИЧЕСКИЕ ФОРМЫ 4-МЕТИЛ-N-[3-(4-МЕТИЛИМИДАЗОЛ-1-ИЛ)-5-ТРИФТОРМЕТИЛФЕНИЛ]-3-(4-ПИРИДИН-3-ИЛПИРИМИДИН-2-ИЛАМИНО)БЕНЗАМИДА (CRYSTALLINE FORMS OF 4-METHYL-N-[3-(4-METHYLIMIDAZOL-1-YL)-5-TRIFLUOROMETHYLPHENYL]-3-(4-PYRIDIN-3-YLPYRIMIDIN-2-YLAMINO)BENZAMIDE) ⤷  Sign Up
South Korea 101651288 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Make Better Decisions: Try a trial or see plans & pricing

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.