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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 three patents protecting this drug.

This drug has one hundred and twenty-eight 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:	128
US Patents:	3
Applicants:	1
NDAs:	1
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.

US Patents and Regulatory Information for 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
Helsinn Hlthcare	TRUSELTIQ	infigratinib phosphate	CAPSULE;ORAL	214622-002	May 28, 2021		RX	Yes	Yes			Y	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	214622-001	May 28, 2021		RX	Yes	No				Y

International Patents for TRUSELTIQ

Country	Patent Number	Estimated Expiration
Spain	2745983
Canada	2570873
Poland	1761505
Singapore	10201408063S
Morocco	39175
World Intellectual Property Organization (WIPO)	2006000420