Details for New Drug Application (NDA): 211673

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NDA 211673 describes XENLETA, which is a drug marketed by Hong Kong and is included in two NDAs. There are four patents protecting this drug. Additional details are available on the XENLETA profile page.

The generic ingredient in XENLETA is lefamulin acetate. Additional details are available on the lefamulin acetate profile page.

Summary for 211673

Tradename:	XENLETA
Applicant:	Hong Kong
Ingredient:	lefamulin acetate
Patents:	3

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 211673

Generic Entry Date for 211673^: ⤷ Start Trial* Constraining patent/regulatory exclusivity: ⤷ Start Trial Dosage: SOLUTION;INTRAVENOUS

^*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.

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	EQ 150MG BASE/15ML (EQ 10MG BASE/ML)
Approval Date:	Aug 19, 2019	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Aug 19, 2029
Regulatory Exclusivity Use:	GENERATING ANTIBIOTIC INCENTIVES NOW
Regulatory Exclusivity Expiration:	Aug 19, 2024
Regulatory Exclusivity Use:	NEW CHEMICAL ENTITY
Patent:	⤷ Start Trial	Patent Expiration:	Jun 14, 2036	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 211673

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Hong Kong	XENLETA	lefamulin acetate	SOLUTION;INTRAVENOUS	211673-001	Aug 19, 2019	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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Summary for 211673

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 211673

Profile for product number 001

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DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 211673