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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 one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the HETLIOZ profile page.

The generic ingredient in HETLIOZ is tasimelteon. One supplier is listed for this compound. Additional details are available on the tasimelteon profile page.

Summary for NDA: 205677

Tradename:
HETLIOZ
Applicant:
Vanda Pharms Inc
Ingredient:
tasimelteon
Patents:3

Pharmacology for NDA: 205677

Mechanism of ActionMelatonin 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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength20MG
Approval Date:Jan 31, 2014TE:RLD:Yes
Regulatory Exclusivity Expiration:Jan 31, 2019
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Jan 31, 2021
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY
Patent:5,856,529Patent Expiration:Dec 9, 2017Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF NON-24-HOUR SLEEP-WAKE DISORDER


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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 verifification 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.

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