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Last Updated: February 29, 2024

Lefamulin acetate - Generic Drug Details


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What are the generic drug sources for lefamulin acetate and what is the scope of freedom to operate?

Lefamulin acetate is the generic ingredient in one branded drug marketed by Nabriva and is included in two NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Lefamulin acetate has eighty-six patent family members in thirty-four countries.

One supplier is listed for this compound.

Summary for lefamulin acetate
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for lefamulin acetate
Generic Entry Dates for lefamulin acetate*:
Constraining patent/regulatory exclusivity:
GENERATING ANTIBIOTIC INCENTIVES NOW
Dosage:
SOLUTION;INTRAVENOUS
Generic Entry Dates for lefamulin acetate*:
Constraining patent/regulatory exclusivity:
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 lefamulin acetate
Anatomical Therapeutic Chemical (ATC) Classes for lefamulin acetate

US Patents and Regulatory Information for lefamulin acetate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Nabriva XENLETA lefamulin acetate TABLET;ORAL 211672-001 Aug 19, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Nabriva XENLETA lefamulin acetate TABLET;ORAL 211672-001 Aug 19, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Nabriva XENLETA lefamulin acetate SOLUTION;INTRAVENOUS 211673-001 Aug 19, 2019 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Nabriva XENLETA lefamulin acetate TABLET;ORAL 211672-001 Aug 19, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for lefamulin acetate

Country Patent Number Title Estimated Expiration
European Patent Office 1972618 Dérivés de pleuromutilin pour le traitement des maladies médiées par des microbes (Pleuromutilin derivatives for the treatment of diseases mediated by microbes) ⤷  Try a Trial
South Korea 20130079406 PROCESS FOR THE PREPARATION OF PLEUROMUTILINS ⤷  Try a Trial
Croatia P20110869 ⤷  Try a Trial
Japan 2014159416 PLEUROMUTILIN DERIVATIVE FOR THERAPY OF DISEASES MEDIATED BY MICROORGANISMS ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for lefamulin acetate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2137143 PA2020531,C2137143 Lithuania ⤷  Try a Trial PRODUCT NAME: LEFAMULINAS, JO DRUSKOS IR SOLVATAI; REGISTRATION NO/DATE: EU/1/20/1457 20200727
2137143 54/2020 Austria ⤷  Try a Trial PRODUCT NAME: LEFAMULIN, SALZE UND SOLVATE DAVON; REGISTRATION NO/DATE: EU/1/20/1457 (MITTEILUNG) 20200728
2137143 132020000000167 Italy ⤷  Try a Trial PRODUCT NAME: LEFAMULINA SUOI SALI E SOLVATI(XENLETA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1457, 20200728
2137143 LUC00178 Luxembourg ⤷  Try a Trial PRODUCT NAME: LEFAMULINE, SELS ET SOLVATES DE CELLE-CI; AUTHORISATION NUMBER AND DATE: EU/1/20/1457 20200728
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.