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Last Updated: March 29, 2024

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*:
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
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:DISCNDosage:SOLUTION;INTRAVENOUSStrengthEQ 150MG BASE/15ML (EQ 10MG BASE/ML)
Approval Date:Aug 19, 2019TE: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:⤷  Try a TrialPatent Expiration:Jan 16, 2029Product Flag?YSubstance Flag?YDelist Request?

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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.