Details for New Drug Application (NDA): 205677

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NDA 205677 describes HETLIOZ, which is a drug marketed by Vanda Pharms Inc and is included in two NDAs. It is available from one supplier. There are thirty-one patents protecting this drug and two Paragraph IV challenges. Additional details are available on the HETLIOZ profile page.

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.

Summary for 205677

Tradename:	HETLIOZ
Applicant:	Vanda Pharms Inc
Ingredient:	tasimelteon
Patents:	30

Pharmacology for NDA: 205677

Mechanism of Action	Melatonin Receptor Agonists

Suppliers and Packaging for NDA: 205677

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
HETLIOZ	tasimelteon	CAPSULE;ORAL	205677	NDA	Vanda Pharmaceuticals Inc.	43068-220	43068-220-01	30 CAPSULE in 1 BOTTLE (43068-220-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	20MG
Approval Date:	Jan 31, 2014	TE:	AB	RLD:	Yes
Regulatory Exclusivity Expiration:	Dec 1, 2027
Regulatory Exclusivity Use:	THE TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENIS SYNDROME (SMS) IN PATIENTS 16 YEARS OF AGE AND OLDER
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 205677

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Vanda Pharms Inc	HETLIOZ	tasimelteon	CAPSULE;ORAL	205677-001	Jan 31, 2014	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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