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Last Updated: January 17, 2021

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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 thirteen 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
Applicant:Vanda Pharms Inc
Generic Entry Opportunity Date for 205677
Generic Entry Date for 205677*:
Constraining patent/regulatory exclusivity:

*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)
Paragraph IV (Patent) Challenges for 205677
Tradename Dosage Ingredient NDA Submissiondate
HETLIOZ CAPSULE;ORAL tasimelteon 205677 2018-01-31

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength20MG
Approval Date:Jan 31, 2014TE:RLD:Yes
Regulatory Exclusivity Expiration:Jan 31, 2021
Regulatory Exclusivity Use:
Patent:  Start TrialPatent Expiration:Feb 12, 2035Product Flag?YSubstance Flag?YDelist Request?
Patent:  Start TrialPatent Expiration:Jan 25, 2033Product Flag?Substance Flag?Delist Request?

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Serving leading biopharmaceutical companies globally:

Harvard Business School
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