TASIGNA Drug Patent Profile
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When do Tasigna patents expire, and when can generic versions of Tasigna launch?
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Pharmaceutical compositions comprising nilotinib hydrochloride monohydrate
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Pharmaceutical compositions comprising nilotinib or its salt
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Method of treating proliferative disorders and other pathological conditions mediated by Bcr-Abl, c-Kit, DDR1, DDR2 or PDGF-R kinase activity
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
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: ⤷ Try a Trial
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: ⤷ Try a Trial
PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷ Try a Trial
PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷ Try a Trial
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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Novartis | TASIGNA | nilotinib hydrochloride | CAPSULE;ORAL | 022068-001 | Oct 29, 2007 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Novartis | TASIGNA | nilotinib hydrochloride | CAPSULE;ORAL | 022068-001 | Oct 29, 2007 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Novartis | TASIGNA | nilotinib hydrochloride | CAPSULE;ORAL | 022068-001 | Oct 29, 2007 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Novartis | TASIGNA | nilotinib hydrochloride | CAPSULE;ORAL | 022068-003 | Mar 22, 2018 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Novartis | TASIGNA | nilotinib hydrochloride | CAPSULE;ORAL | 022068-002 | Jun 17, 2010 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
>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 | 022068-002 | Jun 17, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
Novartis | TASIGNA | nilotinib hydrochloride | CAPSULE;ORAL | 022068-001 | Oct 29, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
Novartis | TASIGNA | nilotinib hydrochloride | CAPSULE;ORAL | 022068-003 | Mar 22, 2018 | ⤷ Try a Trial | ⤷ Try a Trial |
>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: ⤷ Try a Trial
Australia
Patent: 10322102
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 2012011693
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 79490
Estimated Expiration: ⤷ Try a Trial
Chile
Patent: 12001270
Estimated Expiration: ⤷ Try a Trial
China
Patent: 2612368
Estimated Expiration: ⤷ Try a Trial
Colombia
Patent: 51690
Estimated Expiration: ⤷ Try a Trial
Croatia
Patent: 0160472
Estimated Expiration: ⤷ Try a Trial
Cyprus
Patent: 17519
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 01384
Estimated Expiration: ⤷ Try a Trial
Ecuador
Patent: 12011903
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 01384
Estimated Expiration: ⤷ Try a Trial
Finland
Patent: 01384
Estimated Expiration: ⤷ Try a Trial
Guatemala
Patent: 1200150
Estimated Expiration: ⤷ Try a Trial
Hong Kong
Patent: 69950
Estimated Expiration: ⤷ Try a Trial
Hungary
Patent: 27307
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 9727
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 29615
Estimated Expiration: ⤷ Try a Trial
Patent: 13511524
Estimated Expiration: ⤷ Try a Trial
Patent: 15180636
Estimated Expiration: ⤷ Try a Trial
Jordan
Patent: 34
Estimated Expiration: ⤷ Try a Trial
Malaysia
Patent: 9956
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 12005694
Estimated Expiration: ⤷ Try a Trial
Montenegro
Patent: 413
Estimated Expiration: ⤷ Try a Trial
Morocco
Patent: 738
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 9968
Estimated Expiration: ⤷ Try a Trial
Peru
Patent: 121476
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 01384
Estimated Expiration: ⤷ Try a Trial
Russian Federation
Patent: 25835
Estimated Expiration: ⤷ Try a Trial
Patent: 12124811
Estimated Expiration: ⤷ Try a Trial
San Marino
Patent: 01600143
Estimated Expiration: ⤷ Try a Trial
Serbia
Patent: 747
Estimated Expiration: ⤷ Try a Trial
Singapore
Patent: 201501169V
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 01384
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 1203328
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 1743315
Estimated Expiration: ⤷ Try a Trial
Patent: 120102635
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 72128
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 98116
Estimated Expiration: ⤷ Try a Trial
Patent: 1141481
Estimated Expiration: ⤷ Try a Trial
Tunisia
Patent: 12000206
Estimated Expiration: ⤷ Try a Trial
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 |
---|---|---|---|
Cuba | 23916 | FORMAS CRISTALINAS DE LA 4-METIL-N-[3-(4-METIL-IMIDAZOL-1-IL)-5-TRIFLUORO-METIL-FENIL]-3-IL-PIRIMIDIN-2-IL-AMINO)-BENZAMIDA | ⤷ Try a Trial |
New Zealand | 564409 | Crystalline forms of 4-methyl-N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-benzamide hydrochloride | ⤷ Try a Trial |
Poland | 3984528 | ⤷ Try a Trial | |
Hong Kong | 1077811 | INHIBITORS OF TYROSINE KINASES | ⤷ Try a Trial |
South Korea | 20150100946 | SALTS OF 4-METHYL-N-[3-(4-METHYL-IMIDAZOL-1-YL)-5-TRIFLUOROMETHYL-PHENYL]-3-(4-PYRIDIN-3-YL-PYRIMIDIN-2-YLAMINO)-BENZAMIDE | ⤷ Try a Trial |
Japan | 4895976 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |