LEMBOREXANT - Generic Drug Details

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

Lemborexant is the generic ingredient in one branded drug marketed by Eisai Inc and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Lemborexant has fifty-three patent family members in thirty-two countries.

One supplier is listed for this compound.

Summary for LEMBOREXANT

International Patents:	53
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	42
Clinical Trials:	27
Patent Applications:	24
What excipients (inactive ingredients) are in LEMBOREXANT?	LEMBOREXANT excipients list
DailyMed Link:	LEMBOREXANT at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for LEMBOREXANT

Generic Entry Date for LEMBOREXANT^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up Dosage: TABLET;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.

Recent Clinical Trials for LEMBOREXANT

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

Sponsor	Phase
Nova Scotia Health Authority	Phase 4
Chulalongkorn University	Phase 1/Phase 2
Brendan Lucey	Phase 2

See all LEMBOREXANT clinical trials

Pharmacology for LEMBOREXANT

Drug Class	Orexin Receptor Antagonist
Mechanism of Action	Cytochrome P450 2B6 Inducers Orexin Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for LEMBOREXANT

N05CJ	Orexin receptor antagonists
N05C	HYPNOTICS AND SEDATIVES
N05	PSYCHOLEPTICS
N	Nervous system

N05CM	Other hypnotics and sedatives
N05C	HYPNOTICS AND SEDATIVES
N05	PSYCHOLEPTICS
N	Nervous system

US Patents and Regulatory Information for LEMBOREXANT

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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
Eisai Inc	DAYVIGO	lemborexant	TABLET;ORAL	212028-001	Apr 7, 2020		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Eisai Inc	DAYVIGO	lemborexant	TABLET;ORAL	212028-001	Apr 7, 2020		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Eisai Inc	DAYVIGO	lemborexant	TABLET;ORAL	212028-002	Apr 7, 2020		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Eisai Inc	DAYVIGO	lemborexant	TABLET;ORAL	212028-001	Apr 7, 2020		RX	Yes	No	⤷ 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

International Patents for LEMBOREXANT

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Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2016063995		⤷ Sign Up
Peru	20131162	COMPUESTOS DE CICLOPROPANO COMO ANTAGONISTAS DEL RECEPTOR DE OREXINA	⤷ Sign Up
Singapore	11201703064W	COMPOSITIONS AND METHODS FOR TREATING INSOMNIA	⤷ Sign Up
South Korea	102444608		⤷ 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.