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-five 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.
There is one tentative approval for the generic drug (nilotinib hydrochloride), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
Summary for TASIGNA
International Patents: | 275 |
US Patents: | 7 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 134 |
Clinical Trials: | 67 |
Patent Applications: | 3,757 |
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 Loss of Exclusivity (LOE) 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 ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ 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.
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 ORINTOLERANCE 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 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Novartis | TASIGNA | nilotinib hydrochloride | CAPSULE;ORAL | 022068-001 | Oct 29, 2007 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Novartis | TASIGNA | nilotinib hydrochloride | CAPSULE;ORAL | 022068-001 | Oct 29, 2007 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Novartis | TASIGNA | nilotinib hydrochloride | CAPSULE;ORAL | 022068-001 | Oct 29, 2007 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Novartis | TASIGNA | nilotinib hydrochloride | CAPSULE;ORAL | 022068-003 | Mar 22, 2018 | 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 |
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
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 |
---|---|---|---|
Croatia | P20151383 | ⤷ Try a Trial | |
Colombia | 6551690 | MÉTODO PARA EL TRATAMIENTO DE TRANSTORNOS PROLIFERATIVOS Y OTRAS CONDICIONES PATOLĂ“GICAS MEDIADAS POR LA ACTIVIDAD DE CINASA DE BCR -ABL, C-KIT,DDR1, DDR2 O PDGF-R | ⤷ Try a Trial |
Spain | 2475066 | ⤷ Try a Trial | |
Israel | 165977 | SUBSTITUTED PYRIMIDINYLAMINOBENZAMIDES , PROCESS FOR THE PREPARATION THEREOF AND PHARMACEUTICAL COMPOSITIONS COMPRISING THE SAME | ⤷ Try a Trial |
Japan | 2011219495 | INHIBITOR OF TYROSINE KINASE | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |