TRUSELTIQ Drug Patent Profile

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

NDA:

214622

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

See all TRUSELTIQ clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for TRUSELTIQ

L01EN	Fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for TRUSELTIQ

TRUSELTIQ is protected by four US patents and two FDA Regulatory Exclusivities.

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

FDA Regulatory Exclusivity protecting TRUSELTIQ

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

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

Australia

Canada

Chile

China

Croatia

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Hong Kong

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

Morocco

New Zealand

Peru

Philippines

Poland

Portugal

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Tunisia

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
Taiwan	I526440
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.)
Hong Kong	1104286	PYRIMIDINE UREA DERIVATIVES AS KINASE INHIBITORS
Eurasian Patent Organization	201691231	ФАРМАЦЕВТИЧЕСКИЕ ЛЕКАРСТВЕННЫЕ ФОРМЫ
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
China	103121973	Pyrimidine urea derivatives as kinase inhibitors