Details for New Drug Application (NDA): 211672

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NDA 211672 describes XENLETA, which is a drug marketed by Nabriva and is included in two NDAs. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the XENLETA profile page.

The generic ingredient in XENLETA is lefamulin acetate. One supplier is listed for this compound. Additional details are available on the lefamulin acetate profile page.

Summary for 211672

Tradename:	XENLETA
Applicant:	Nabriva
Ingredient:	lefamulin acetate
Patents:	3

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 211672

Generic Entry Date for 211672^: ⤷ Subscribe* Constraining patent/regulatory exclusivity: 9,120,727 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.

Pharmacology for NDA: 211672

Mechanism of Action	Cytochrome P450 3A Inhibitors Cytochrome P450 3A4 Inhibitors

Suppliers and Packaging for NDA: 211672

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
XENLETA	lefamulin acetate	TABLET;ORAL	211672	NDA	Nabriva Therapeutics US, Inc.	72000-110	72000-110-10	10 TABLET, COATED in 1 BLISTER PACK (72000-110-10)
XENLETA	lefamulin acetate	TABLET;ORAL	211672	NDA	Nabriva Therapeutics US, Inc.	72000-110	72000-110-30	30 TABLET, COATED in 1 BOTTLE (72000-110-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 600MG BASE
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:	8,071,643	Patent Expiration:	Jan 16, 2029	Product Flag?	Y	Substance Flag?	Y	Delist Request?

Expired US Patents for NDA 211672

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Nabriva	XENLETA	lefamulin acetate	TABLET;ORAL	211672-001	Aug 19, 2019	6,753,445	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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