Details for New Drug Application (NDA): 214517

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NDA 214517 describes HETLIOZ LQ, which is a drug marketed by Vanda Pharms Inc and is included in one NDA. It is available from one supplier. There are twenty-five patents protecting this drug. Additional details are available on the HETLIOZ LQ profile page.

The generic ingredient in HETLIOZ LQ 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.

Summary for 214517

Tradename:	HETLIOZ LQ
Applicant:	Vanda Pharms Inc
Ingredient:	tasimelteon
Patents:	25

Pharmacology for NDA: 214517

Mechanism of Action	Melatonin Receptor Agonists

Suppliers and Packaging for NDA: 214517

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
HETLIOZ LQ	tasimelteon	SUSPENSION;ORAL	214517	NDA	Vanda Pharmaceuticals Inc.	43068-304	43068-304-02	1 BOTTLE in 1 CARTON (43068-304-02) / 48 mL in 1 BOTTLE
HETLIOZ LQ	tasimelteon	SUSPENSION;ORAL	214517	NDA	Vanda Pharmaceuticals Inc.	43068-304	43068-304-06	1 BOTTLE in 1 CARTON (43068-304-06) / 158 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION;ORAL			Strength	4MG/ML
Approval Date:	Dec 1, 2020	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Dec 1, 2027
Regulatory Exclusivity Use:	FOR THE TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME (SMS) IN PEDIATRIC PATIENTS 3 TO 15 YEARS OF AGE
Patent:	⤷ Sign Up	Patent Expiration:	Feb 12, 2035	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patent:	⤷ Sign Up	Patent Expiration:	Jan 25, 2033	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME NON-24 HOUR SLEEP-WAKE DISORDER BY AVOIDING THE USE OF TASIMELTEON IN COMBINATION WITH CYP1A2 STRONG INHIBITORS

Expired US Patents for NDA 214517

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Vanda Pharms Inc	HETLIOZ LQ	tasimelteon	SUSPENSION;ORAL	214517-001	Dec 1, 2020	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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