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
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 |


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
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.
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 |