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 two branded drugs marketed by Vanda Pharms Inc and is included in two NDAs. There are twenty 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 eighty-four patent family members in thirty-one countries.

There are three drug master file entries for tasimelteon. One supplier is listed for this compound. There are two tentative approvals for this compound.

Summary for tasimelteon

International Patents:	184
US Patents:	20
Tradenames:	2
Applicants:	1
NDAs:	2
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	47
Clinical Trials:	20
Patent Applications:	421
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

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

Generic filers with tentative approvals for TASIMELTEON

Applicant	Application No.	Strength	Dosage Form
See Plans and Pricing	See Plans and Pricing	20MG	CAPSULE; ORAL
See Plans and Pricing	See Plans and Pricing	20MG	CAPSULE; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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	tasimelteon	CAPSULE;ORAL	205677-001	Jan 31, 2014		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing	Y	Y		See Plans and Pricing
Vanda Pharms Inc	HETLIOZ	tasimelteon	CAPSULE;ORAL	205677-001	Jan 31, 2014		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing	Y	Y		See Plans and Pricing
Vanda Pharms Inc	HETLIOZ	tasimelteon	CAPSULE;ORAL	205677-001	Jan 31, 2014		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Vanda Pharms Inc	HETLIOZ LQ	tasimelteon	SUSPENSION;ORAL	214517-001	Dec 1, 2020		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Vanda Pharms Inc	HETLIOZ LQ	tasimelteon	SUSPENSION;ORAL	214517-001	Dec 1, 2020		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing	Y	Y		See Plans and Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity 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
World Intellectual Property Organization (WIPO)	2015123389		See Plans and Pricing
Australia	2015206797	Administration of tasimelteon under fasted conditions	See Plans and Pricing
Norway	992804		See Plans and Pricing
Spain	2230626		See Plans and Pricing
Mexico	2017002796	TASIMELTEON PARA TRATAR EL SINDROME DE SMITH-MAGENIS. (TASIMELTEON FOR TREATING SMITH-MAGENIS SYNDROME.)	See Plans and Pricing
>Country	>Patent Number	>Title	>Estimated Expiration

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