Details for New Drug Application (NDA): 211673

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NDA 211673 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 211673

Tradename:	XENLETA
Applicant:	Nabriva
Ingredient:	lefamulin acetate
Patents:	2

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

Generic Entry Date for 211673^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: GENERATING ANTIBIOTIC INCENTIVES NOW 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.

Pharmacology for NDA: 211673

Mechanism of Action	Acidifying Activity Calcium Chelating Activity Cytochrome P450 3A Inhibitors Cytochrome P450 3A4 Inhibitors
Physiological Effect	Decreased Coagulation Factor Activity

Suppliers and Packaging for NDA: 211673

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
XENLETA	lefamulin acetate	SOLUTION;INTRAVENOUS	211673	NDA	Nabriva Therapeutics US, Inc.	72000-030	72000-030-06	6 BAG in 1 CARTON (72000-030-06) / 270 mL in 1 BAG (72000-030-01)
XENLETA	lefamulin acetate	SOLUTION;INTRAVENOUS	211673	NDA	Nabriva Therapeutics US, Inc.	72000-120	72000-120-06	6 VIAL, SINGLE-USE in 1 CARTON (72000-120-06) / 15 mL in 1 VIAL, SINGLE-USE (72000-120-01)

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:	⤷ Sign Up	Patent Expiration:	Jan 16, 2029	Product Flag?	Y	Substance Flag?	Y	Delist Request?

Expired US Patents for NDA 211673

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Nabriva	XENLETA	lefamulin acetate	SOLUTION;INTRAVENOUS	211673-001	Aug 19, 2019	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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