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Last Updated: December 5, 2023

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 twenty-four 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-seven patent family members in twenty-four countries.

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

Summary for tasimelteon

International Patents:	197
US Patents:	24
Tradenames:	3
Applicants:	4
NDAs:	5
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	57
Clinical Trials:	21
Patent Applications:	314
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

Recent Clinical Trials for tasimelteon

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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	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 LQ	tasimelteon	SUSPENSION;ORAL	214517-001	Dec 1, 2020		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y	Y		⤷ Try a Trial
Vanda Pharms Inc	HETLIOZ	tasimelteon	CAPSULE;ORAL	205677-001	Jan 31, 2014	AB	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Vanda Pharms Inc	HETLIOZ LQ	tasimelteon	SUSPENSION;ORAL	214517-001	Dec 1, 2020		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Vanda Pharms Inc	HETLIOZ LQ	tasimelteon	SUSPENSION;ORAL	214517-001	Dec 1, 2020		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Vanda Pharms Inc	HETLIOZ	tasimelteon	CAPSULE;ORAL	205677-001	Jan 31, 2014	AB	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>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	tasimelteon	CAPSULE;ORAL	205677-001	Jan 31, 2014	⤷ Try a Trial	⤷ Try a Trial
Vanda Pharms Inc	HETLIOZ LQ	tasimelteon	SUSPENSION;ORAL	214517-001	Dec 1, 2020	⤷ Try a Trial	⤷ Try a Trial
>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
China	105142630	Treatment of circadian rhythm disorders	⤷ Try a Trial
South Korea	20220113983	액체 타시멜테온 제형 및 이의 사용 방법	⤷ Try a Trial
Canada	2861108	TRAITEMENT DE TROUBLES DU RYTHME CIRCADIEN (TREATMENT OF CIRCADIAN RHYTHM DISORDERS)	⤷ Try a Trial
Japan	2017526693	スミス‐マゲニス症候群を治療するためのタシメルテオン	⤷ Try a Trial
Japan	2019038822	概日リズム障害の治療 (TREATMENT OF CIRCADIAN RHYTHM DISORDERS)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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