Time limited offer for new users ▶ Get up to 3 months free

Serving leading biopharmaceutical companies globally:

Dow
Boehringer Ingelheim
Colorcon
AstraZeneca
Merck
Moodys

Last Updated: February 9, 2023

TRUSELTIQ Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions


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

< Available with Subscription >

  Try it Free

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
Drug patent expirations by year for TRUSELTIQ
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

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 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

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 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Helsinn Hlthcare TRUSELTIQ infigratinib phosphate CAPSULE;ORAL 214622-002 May 28, 2021 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Helsinn Hlthcare TRUSELTIQ infigratinib phosphate CAPSULE;ORAL 214622-001 May 28, 2021 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Helsinn Hlthcare TRUSELTIQ infigratinib phosphate CAPSULE;ORAL 214622-002 May 28, 2021 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Helsinn Hlthcare TRUSELTIQ infigratinib phosphate CAPSULE;ORAL 214622-002 May 28, 2021 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Helsinn Hlthcare TRUSELTIQ infigratinib phosphate CAPSULE;ORAL 214622-001 May 28, 2021 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Helsinn Hlthcare TRUSELTIQ infigratinib phosphate CAPSULE;ORAL 214622-001 May 28, 2021 RX Yes No 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 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

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Moodys
Boehringer Ingelheim
Merck
McKesson
Mallinckrodt
McKinsey

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.