TRUSELTIQ Drug Patent Profile
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Which patents cover Truseltiq, and what generic alternatives are available?
Truseltiq is a drug marketed by Helsinn Hlthcare and is included in one NDA. There are four patents protecting this drug.
This drug has one hundred and thirty-three patent family members in forty countries.
The generic ingredient in TRUSELTIQ is infigratinib phosphate. One supplier is listed for this compound. Additional details are available on the infigratinib phosphate profile page.
DrugPatentWatch® Generic Entry Outlook for Truseltiq
Truseltiq will be eligible for patent challenges on May 28, 2025. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be December 11, 2034. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for TRUSELTIQ
International Patents: | 133 |
US Patents: | 4 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 107 |
Clinical Trials: | 2 |
Patent Applications: | 590 |
What excipients (inactive ingredients) are in TRUSELTIQ? | TRUSELTIQ excipients list |
DailyMed Link: | TRUSELTIQ at DailyMed |

DrugPatentWatch® Estimated Generic Entry Opportunity Date for TRUSELTIQ
Generic Entry Date for TRUSELTIQ*:
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 TRUSELTIQ
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Emory University | Phase 2 |
National Cancer Institute (NCI) | Phase 2 |
Stanford University | Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for TRUSELTIQ
US Patents and Regulatory Information for TRUSELTIQ
TRUSELTIQ is protected by four US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of TRUSELTIQ 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 TRUSELTIQ
Pharmaceutical dosage forms
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Pharmaceutical dosage forms
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Compounds and compositions as protein kinase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Crystalline forms of 3-(2,6-dichloro-3,5-dimethoxy-phenyl)-1-{6-[4-(4-ethyl-piperazin-1-yl) -phenylamino]-pyrimidin-4-yl}-1-methyl-urea and salts thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
FDA Regulatory Exclusivity protecting TRUSELTIQ
NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing
FOR TREATMENT OF ADULTS WITH PREVIOUSLY TREATED, UNRESECTABLE LOCALLY ADVANCED OR METASTATIC CHOLANGIOCARCINOMA WITH A FIBROBLAST GROWTH FACTOR RECEPTOR 2 (FGFR2) FUSION OR OTHER REARRANGEMENT AS DETECTED BY AN FDA-APPROVED TEST
Exclusivity Expiration: See Plans and Pricing
International Patents for TRUSELTIQ
When does loss-of-exclusivity occur for TRUSELTIQ?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Argentina
Patent: 8716
Estimated Expiration: See Plans and Pricing
Australia
Patent: 14362999
Estimated Expiration: See Plans and Pricing
Canada
Patent: 30055
Estimated Expiration: See Plans and Pricing
Chile
Patent: 16001436
Estimated Expiration: See Plans and Pricing
China
Patent: 5813635
Estimated Expiration: See Plans and Pricing
Croatia
Patent: 0191691
Estimated Expiration: See Plans and Pricing
Denmark
Patent: 79667
Estimated Expiration: See Plans and Pricing
Ecuador
Patent: 16060194
Estimated Expiration: See Plans and Pricing
Eurasian Patent Organization
Patent: 6288
Estimated Expiration: See Plans and Pricing
Patent: 1691231
Estimated Expiration: See Plans and Pricing
European Patent Office
Patent: 79667
Estimated Expiration: See Plans and Pricing
Patent: 97179
Estimated Expiration: See Plans and Pricing
Hong Kong
Patent: 23833
Estimated Expiration: See Plans and Pricing
Hungary
Patent: 45156
Estimated Expiration: See Plans and Pricing
Israel
Patent: 5705
Estimated Expiration: See Plans and Pricing
Japan
Patent: 22619
Estimated Expiration: See Plans and Pricing
Patent: 04585
Estimated Expiration: See Plans and Pricing
Patent: 17502941
Estimated Expiration: See Plans and Pricing
Patent: 19142927
Estimated Expiration: See Plans and Pricing
Lithuania
Patent: 79667
Estimated Expiration: See Plans and Pricing
Malaysia
Patent: 4303
Estimated Expiration: See Plans and Pricing
Mexico
Patent: 16007652
Estimated Expiration: See Plans and Pricing
Morocco
Patent: 175
Estimated Expiration: See Plans and Pricing
New Zealand
Patent: 9865
Estimated Expiration: See Plans and Pricing
Patent: 0002
Estimated Expiration: See Plans and Pricing
Peru
Patent: 160851
Estimated Expiration: See Plans and Pricing
Philippines
Patent: 016501039
Estimated Expiration: See Plans and Pricing
Poland
Patent: 79667
Estimated Expiration: See Plans and Pricing
Portugal
Patent: 79667
Estimated Expiration: See Plans and Pricing
Serbia
Patent: 270
Estimated Expiration: See Plans and Pricing
Singapore
Patent: 202104627U
Estimated Expiration: See Plans and Pricing
Slovenia
Patent: 79667
Estimated Expiration: See Plans and Pricing
South Africa
Patent: 1603064
Estimated Expiration: See Plans and Pricing
South Korea
Patent: 2349893
Estimated Expiration: See Plans and Pricing
Patent: 160096093
Estimated Expiration: See Plans and Pricing
Spain
Patent: 45983
Estimated Expiration: See Plans and Pricing
Taiwan
Patent: 21938
Estimated Expiration: See Plans and Pricing
Patent: 1605494
Estimated Expiration: See Plans and Pricing
Patent: 2128137
Estimated Expiration: See Plans and Pricing
Tunisia
Patent: 16000207
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 TRUSELTIQ around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Spain | 2745983 | See Plans and Pricing | |
Taiwan | I526440 | See Plans and Pricing | |
China | 111100077 | 3-(2,6-二氯-3,5-二甲氧基-苯基)-1-{6-[4-(4-乙基-哌嗪-1-基)-苯基氨基]-嘧啶-4-基}-1-甲基-脲及其盐的晶型 (Crystalline forms of 3-(2,6-dichloro-3,5-dimethoxy-phenyl) -1-{6-[4-(4-ethyl-piperazin-1-yl)-phenylamino] -pyrimidin-4-yl}-1-methyl-urea and salts thereof.) | See Plans and Pricing |
Hong Kong | 1104286 | PYRIMIDINE UREA DERIVATIVES AS KINASE INHIBITORS | See Plans and Pricing |
Eurasian Patent Organization | 201691231 | ФАРМАЦЕВТИЧЕСКИЕ ЛЕКАРСТВЕННЫЕ ФОРМЫ | See Plans and Pricing |
Guatemala | 201200181 | FORMAS CRISTALINAS DE 3-(2,6-DICLORO-3,5-DIMETOXI-FENIL)-1-{6-[4-(4-ETIL-PIPERAZIN-1-IL}-FENIL-AMINO]-PIRIMIDIN-4-IL]-1-METIL-UREA Y SALES DE LAS MISMAS | See Plans and Pricing |
China | 103121973 | Pyrimidine urea derivatives as kinase inhibitors | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |