Details for New Drug Application (NDA): 214517

✉ Email this page to a colleague

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:	10,071,977	Patent Expiration:	Feb 12, 2035	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patent:	10,149,829	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

Subscribe to access the full database, or Subscribe
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	5,856,529	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.