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 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.
Summary for TASIGNA
International Patents: | 290 |
US Patents: | 7 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 133 |
Clinical Trials: | 67 |
Patent Applications: | 4,662 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for TASIGNA |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for TASIGNA |
What excipients (inactive ingredients) are in TASIGNA? | TASIGNA excipients list |
DailyMed Link: | TASIGNA at DailyMed |
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 |
Pharmacology for TASIGNA
Anatomical Therapeutic Chemical (ATC) Classes for TASIGNA
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
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Salts of 4-methyl-N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-- 3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-Benzamide
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Pharmaceutical compositions comprising nilotinib hydrochloride monohydrate
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Salts of 4-methyl N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyridin-3-yl- -pyrimidin-2-ylamino)-benzamide
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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
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Pharmaceutical compositions comprising nilotinib or its salt
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Method of treating proliferative disorders and other pathological conditions mediated by Bcr-Abl, c-Kit, DDR1, DDR2 or PDGF-R kinase activity
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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
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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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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 | 022068-001 | Oct 29, 2007 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | TASIGNA | nilotinib hydrochloride | CAPSULE;ORAL | 022068-002 | Jun 17, 2010 | ⤷ 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
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Brazil
Patent: 2012011693
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 79490
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Chile
Patent: 12001270
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China
Patent: 2612368
Estimated Expiration: ⤷ Sign Up
Colombia
Patent: 51690
Estimated Expiration: ⤷ Sign Up
Croatia
Patent: 0160472
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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
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Jordan
Patent: 34
Estimated Expiration: ⤷ Sign Up
Malaysia
Patent: 9956
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 12005694
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Montenegro
Patent: 413
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Morocco
Patent: 738
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New Zealand
Patent: 9968
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Peru
Patent: 121476
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Poland
Patent: 01384
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Russian Federation
Patent: 25835
Estimated Expiration: ⤷ Sign Up
Patent: 12124811
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San Marino
Patent: 01600143
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Serbia
Patent: 747
Estimated Expiration: ⤷ Sign Up
Singapore
Patent: 201501169V
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Slovenia
Patent: 01384
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South Africa
Patent: 1203328
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South Korea
Patent: 1743315
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Patent: 120102635
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Spain
Patent: 72128
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Taiwan
Patent: 98116
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Patent: 1141481
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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 |
---|---|---|---|
Slovenia | 2284167 | ⤷ Sign Up | |
Spain | 2475066 | ⤷ Sign Up | |
Israel | 165977 | SUBSTITUTED PYRIMIDINYLAMINOBENZAMIDES , PROCESS FOR THE PREPARATION THEREOF AND PHARMACEUTICAL COMPOSITIONS COMPRISING THE SAME | ⤷ Sign Up |
Portugal | 2284167 | ⤷ Sign Up | |
Japan | 2011219495 | INHIBITOR OF TYROSINE KINASE | ⤷ Sign Up |
Russian Federation | 2483065 | СОЛИ 4-МЕТИЛ-N-[3-(4-МЕТИЛИМИДАЗОЛ-1-ИЛ)-5-ТРИФТОРМЕТИЛФЕНИЛ]-3-(4-ПИРИДИН-3-ИЛПИРИМИДИН-2-ИЛАМИНО) БЕНЗАМИДА (4-METHYL-N-[3-(4-METHYLIMIDAZOL-1-YL)-5-TRIFLUOROMETHYLPHENYL]-3-(4-PYRIDIN-3-YL-PYRIMIDIN-2-YLAMINO)BENZAMIDE SALTS) | ⤷ Sign Up |
Japan | 2010504942 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |