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Last Updated: April 24, 2024

TRUSELTIQ Drug Patent Profile


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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

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Summary for TRUSELTIQ
International Patents:135
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
Drug patent expirations by year for TRUSELTIQ
Drug Prices for TRUSELTIQ

See drug prices for TRUSELTIQ

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

SponsorPhase
Emory UniversityPhase 2
National Cancer Institute (NCI)Phase 2
Stanford UniversityPhase 2

See all TRUSELTIQ clinical trials

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
Helsinn Hlthcare TRUSELTIQ infigratinib phosphate CAPSULE;ORAL 214622-002 May 28, 2021 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  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
Norway 338287 ⤷  Try a Trial
China 101035769 Pyrimidine urea derivatives as kinase inhibitors ⤷  Try a Trial
Argentina 079257 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 ⤷  Try a Trial
China 111269186 激酶抑制剂及其盐的晶型 (Crystalline forms of kinase inhibitors and salt thereof) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.