Tasimelteon - Generic Drug Details

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What are the generic drug sources for tasimelteon and what is the scope of patent protection?

Tasimelteon is the generic ingredient in three branded drugs marketed by Vanda Pharms Inc, Apotex, MSN, and Teva Pharms Usa Inc, and is included in five NDAs. There are thirty-one patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Tasimelteon has one hundred and ninety-eight patent family members in twenty-four countries.

There are three drug master file entries for tasimelteon. Four suppliers are listed for this compound.

Summary for tasimelteon

International Patents:	198
US Patents:	31
Tradenames:	3
Applicants:	4
NDAs:	5
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	57
Clinical Trials:	21
Patent Applications:	285
Drug Prices:	Drug price trends for tasimelteon
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for tasimelteon
What excipients (inactive ingredients) are in tasimelteon?	tasimelteon excipients list
DailyMed Link:	tasimelteon at DailyMed

See drug prices for tasimelteon

Recent Clinical Trials for tasimelteon

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Saint-Joseph University	Phase 3
Vanda Pharmaceuticals	Phase 2
Vanda Pharmaceuticals	Phase 4

See all tasimelteon clinical trials

Pharmacology for tasimelteon

Drug Class	Melatonin Receptor Agonist
Mechanism of Action	Melatonin Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for tasimelteon

N05CH	Melatonin receptor agonists
N05C	HYPNOTICS AND SEDATIVES
N05	PSYCHOLEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for TASIMELTEON

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
HETLIOZ LQ	Oral Suspension	tasimelteon	4 mg/mL	214517	1	2024-04-01
HETLIOZ	Capsules	tasimelteon	20 mg	205677	3	2018-01-31

US Patents and Regulatory Information for tasimelteon

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Vanda Pharms Inc	HETLIOZ	tasimelteon	CAPSULE;ORAL	205677-001	Jan 31, 2014	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Vanda Pharms Inc	HETLIOZ	tasimelteon	CAPSULE;ORAL	205677-001	Jan 31, 2014	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Vanda Pharms Inc	HETLIOZ LQ	tasimelteon	SUSPENSION;ORAL	214517-001	Dec 1, 2020		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Vanda Pharms Inc	HETLIOZ LQ	tasimelteon	SUSPENSION;ORAL	214517-001	Dec 1, 2020		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for tasimelteon

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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	⤷ Sign Up	⤷ Sign Up
Vanda Pharms Inc	HETLIOZ	tasimelteon	CAPSULE;ORAL	205677-001	Jan 31, 2014	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for tasimelteon

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Vanda Pharmaceuticals Netherlands B.V.	Hetlioz	tasimelteon	EMEA/H/C/003870 Hetlioz is indicated for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) in totally blind adults.,	Authorised	no	no	yes	2015-07-03
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for tasimelteon

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Country	Patent Number	Title	Estimated Expiration
Hungary	E034876		⤷ Sign Up
Japan	2019038822		⤷ Sign Up
Australia	2016204178		⤷ Sign Up
Israel	266159	טיפול בהפרעות במקצב הצירקדיאני (Treatment of circadian rhythm disorders)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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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 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.