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-four patent family members in forty countries.
The generic ingredient in TRUSELTIQ is infigratinib phosphate. 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: | 134 |
US Patents: | 4 |
Applicants: | 1 |
NDAs: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 33 |
Clinical Trials: | 2 |
Patent Applications: | 12 |
Drug Prices: | Drug price information for TRUSELTIQ |
What excipients (inactive ingredients) are in TRUSELTIQ? | TRUSELTIQ excipients list |
DailyMed Link: | TRUSELTIQ at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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 |
United States Department of Defense | 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 ⤷ 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 TRUSELTIQ
Pharmaceutical dosage forms
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Pharmaceutical dosage forms
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Compounds and compositions as protein kinase inhibitors
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
FDA Regulatory Exclusivity protecting TRUSELTIQ
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Try a Trial
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: ⤷ 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Helsinn Hlthcare | TRUSELTIQ | infigratinib phosphate | CAPSULE;ORAL | 214622-001 | May 28, 2021 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Helsinn Hlthcare | TRUSELTIQ | infigratinib phosphate | CAPSULE;ORAL | 214622-002 | May 28, 2021 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Helsinn Hlthcare | TRUSELTIQ | infigratinib phosphate | CAPSULE;ORAL | 214622-001 | May 28, 2021 | DISCN | 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 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: ⤷ Try a Trial
Australia
Patent: 14362999
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 30055
Estimated Expiration: ⤷ Try a Trial
Chile
Patent: 16001436
Estimated Expiration: ⤷ Try a Trial
China
Patent: 5813635
Estimated Expiration: ⤷ Try a Trial
Patent: 6942629
Estimated Expiration: ⤷ Try a Trial
Croatia
Patent: 0191691
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 79667
Estimated Expiration: ⤷ Try a Trial
Ecuador
Patent: 16060194
Estimated Expiration: ⤷ Try a Trial
Eurasian Patent Organization
Patent: 6288
Estimated Expiration: ⤷ Try a Trial
Patent: 1691231
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 79667
Estimated Expiration: ⤷ Try a Trial
Patent: 97179
Estimated Expiration: ⤷ Try a Trial
Hong Kong
Patent: 23833
Estimated Expiration: ⤷ Try a Trial
Hungary
Patent: 45156
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 5705
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 22619
Estimated Expiration: ⤷ Try a Trial
Patent: 04585
Estimated Expiration: ⤷ Try a Trial
Patent: 17502941
Estimated Expiration: ⤷ Try a Trial
Patent: 19142927
Estimated Expiration: ⤷ Try a Trial
Lithuania
Patent: 79667
Estimated Expiration: ⤷ Try a Trial
Malaysia
Patent: 4303
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 16007652
Estimated Expiration: ⤷ Try a Trial
Morocco
Patent: 175
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 9865
Estimated Expiration: ⤷ Try a Trial
Patent: 0002
Estimated Expiration: ⤷ Try a Trial
Peru
Patent: 160851
Estimated Expiration: ⤷ Try a Trial
Philippines
Patent: 016501039
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 79667
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 79667
Estimated Expiration: ⤷ Try a Trial
Serbia
Patent: 270
Estimated Expiration: ⤷ Try a Trial
Singapore
Patent: 202104627U
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 79667
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 1603064
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 2349893
Estimated Expiration: ⤷ Try a Trial
Patent: 160096093
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 45983
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 21938
Estimated Expiration: ⤷ Try a Trial
Patent: 00759
Estimated Expiration: ⤷ Try a Trial
Patent: 1605494
Estimated Expiration: ⤷ Try a Trial
Patent: 2128137
Estimated Expiration: ⤷ Try a Trial
Tunisia
Patent: 16000207
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 TRUSELTIQ around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Australia | 2005256491 | Pyrimidine urea derivatives as kinase inhibitors | ⤷ Try a Trial |
Malaysia | 194303 | PHARMACEUTICAL DOSAGE FORMS | ⤷ Try a Trial |
Philippines | 12014502593 | 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 | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |