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Last Updated: June 24, 2022

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 fourteen 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. One supplier is 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:14
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 214517
Generic Entry Date for 214517*:
Constraining patent/regulatory exclusivity:
Dosage:
SUSPENSION;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.

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:RXDosage:SUSPENSION;ORALStrength4MG/ML
Approval Date:Dec 1, 2020TE: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
Regulatory Exclusivity Expiration:Dec 1, 2023
Regulatory Exclusivity Use:NEW PRODUCT
Patent:See Plans and PricingPatent Expiration:Feb 12, 2035Product Flag?YSubstance Flag?YDelist Request?

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Serving leading biopharmaceutical companies globally:

Medtronic
AstraZeneca
Dow
McKinsey
Colorcon
Mallinckrodt

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.