Get our Free Drug Patent Expiration Updates

Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
Covington
Queensland Health
McKinsey
Express Scripts
Chubb
Fuji
Julphar
Colorcon

Generated: September 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205677

« Back to Dashboard

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 seven 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. One supplier is 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:7
Generic Entry Opportunity Date for 205677
Generic Entry Date for 205677*:
Constraining patent/regulatory exclusivity:
TREATMENT OF NON-24-HOUR SLEEP-WAKE DISORDER
Dosage:
CAPSULE;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: 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)

Profile 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:TREATMENT OF NON-24-HOUR SLEEP-WAKE DISORDER
Patent:➤ Try a Free TrialPatent Expiration:Dec 9, 2018Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF NON-24 HOUR SLEEP-WAKE DISORDER BY ADMINISTERING TASIMELTEON

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Chubb
Deloitte
Cerilliant
Medtronic
Chinese Patent Office
McKesson
Farmers Insurance
Accenture
US Department of Justice

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.