HETLIOZ Drug Patent Profile

When do Hetlioz patents expire, and what generic alternatives are available?

Hetlioz is a drug marketed by Vanda Pharms Inc and is included in two NDAs. There are thirty-three patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and seventeen patent family members in twenty-four countries.

The generic ingredient in HETLIOZ is tasimelteon. There are three drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the tasimelteon profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Hetlioz

A generic version of HETLIOZ was approved as tasimelteon by TEVA PHARMS USA INC on December 12^th, 2022.

Summary for HETLIOZ

International Patents:	217
US Patents:	31
Applicants:	1
NDAs:	2
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for HETLIOZ

Paragraph IV (Patent) Challenges for HETLIOZ

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
HETLIOZ	Capsules	tasimelteon	20 mg	205677	3	2018-01-31

US Patents and Regulatory Information for HETLIOZ

HETLIOZ is protected by forty-eight US patents and one FDA Regulatory Exclusivity.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Vanda Pharms Inc	HETLIOZ LQ	tasimelteon	SUSPENSION;ORAL	214517-001	Dec 1, 2020		RX	Yes	Yes	10,829,465		Y	Y
Vanda Pharms Inc	HETLIOZ	tasimelteon	CAPSULE;ORAL	205677-001	Jan 31, 2014	AB	RX	Yes	Yes	11,285,129
Vanda Pharms Inc	HETLIOZ	tasimelteon	CAPSULE;ORAL	205677-001	Jan 31, 2014	AB	RX	Yes	Yes
Vanda Pharms Inc	HETLIOZ LQ	tasimelteon	SUSPENSION;ORAL	214517-001	Dec 1, 2020		RX	Yes	Yes	10,610,511
Vanda Pharms Inc	HETLIOZ	tasimelteon	CAPSULE;ORAL	205677-001	Jan 31, 2014	AB	RX	Yes	Yes	12,049,457		Y	Y
Vanda Pharms Inc	HETLIOZ LQ	tasimelteon	SUSPENSION;ORAL	214517-001	Dec 1, 2020		RX	Yes	Yes	11,141,400
Vanda Pharms Inc	HETLIOZ LQ	tasimelteon	SUSPENSION;ORAL	214517-001	Dec 1, 2020		RX	Yes	Yes	9,730,910

International Patents for HETLIOZ

When does loss-of-exclusivity occur for HETLIOZ?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

European Patent Office

Japan

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 HETLIOZ around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3105212	TASIMELTÉON DE QUALITÉ PHARMACEUTIQUE, HAUTEMENT PURIFIÉ (HIGHLY PURIFIED PHARMACEUTICAL GRADE TASIMELTEON)
European Patent Office	3470405	TASIMELTEON DE QUALITÉ PHARMACEUTIQUE HAUTEMENT PURIFIÉE (HIGHLY PURIFIED PHARMACEUTICAL GRADE TASIMELTEON)
European Patent Office	4223747	TASIMELTEON DE QUALITÉ PHARMACEUTIQUE HAUTEMENT PURIFIÉ (HIGHLY PURIFIED PHARMACEUTICAL GRADE TASIMELTEON)
Japan	2017506642	高純度医薬品等級タシメルテオン
Japan	2020079248	高純度医薬品等級タシメルテオン (HIGHLY PURIFIED PHARMACEUTICAL GRADE TASIMELTEON)
Japan	2022088624	高純度医薬品等級タシメルテオン
Japan	2022190155	高純度医薬品等級タシメルテオン