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. It is available from one supplier. There are four 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:	Hong Kong
Ingredient:	lefamulin acetate
Patents:	3

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

Generic Entry Date for 211673^: ⤷ Get Started Free* Constraining patent/regulatory exclusivity: 8,071,643 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:	12,121,582	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	6,753,445	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent 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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.