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Last Updated: August 17, 2022

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-four patent family members in thirty-three countries.

Summary for lefamulin acetate
International Patents:84
US Patents:3
Tradenames:1
Applicants:1
NDAs:2
Raw Ingredient (Bulk) Api Vendors: 16
Patent Applications: 4
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for lefamulin acetate
What excipients (inactive ingredients) are in lefamulin acetate?lefamulin acetate excipients list
DailyMed Link:lefamulin acetate at DailyMed
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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Nabriva XENLETA lefamulin acetate TABLET;ORAL 211672-001 Aug 19, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Nabriva XENLETA lefamulin acetate SOLUTION;INTRAVENOUS 211673-001 Aug 19, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Nabriva XENLETA lefamulin acetate SOLUTION;INTRAVENOUS 211673-001 Aug 19, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Nabriva XENLETA lefamulin acetate SOLUTION;INTRAVENOUS 211673-001 Aug 19, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Nabriva XENLETA lefamulin acetate TABLET;ORAL 211672-001 Aug 19, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for lefamulin acetate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Nabriva XENLETA lefamulin acetate SOLUTION;INTRAVENOUS 211673-001 Aug 19, 2019 See Plans and Pricing See Plans and Pricing
Nabriva XENLETA lefamulin acetate TABLET;ORAL 211672-001 Aug 19, 2019 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for lefamulin acetate

Country Patent Number Title Estimated Expiration
European Patent Office 2399904 Procédé de préparation de pleuromutilines (Process for the preparation of pleuromutilins) See Plans and Pricing
Taiwan I585073 See Plans and Pricing
Japan 6038021 See Plans and Pricing
China 101668738 Pleuromutilin derivatives for the treatment of diseases mediated by microbes See Plans and Pricing
Japan 6501742 See Plans and Pricing
European Patent Office 2137143 DÉRIVÉS DE PLEUROMUTILINE POUR LE TRAITEMENT DE MALADIES TRANSMISES PAR DES MICROBES (PLEUROMUTILIN DERIVATIVES FOR THE TREATMENT OF DISEASES MEDIATED BY MICROBES) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for lefamulin acetate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2137143 54/2020 Austria See Plans and Pricing PRODUCT NAME: LEFAMULIN, SALZE UND SOLVATE DAVON; REGISTRATION NO/DATE: EU/1/20/1457 (MITTEILUNG) 20200728
2137143 132020000000167 Italy See Plans and Pricing PRODUCT NAME: LEFAMULINA SUOI SALI E SOLVATI(XENLETA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1457, 20200728
2137143 CA 2020 00046 Denmark See Plans and Pricing PRODUCT NAME: LEFAMULIN, SALTE OG SOLVATER DERAF; REG. NO/DATE: EU/1/20/1457 20200728
2137143 LUC00178 Luxembourg See Plans and Pricing PRODUCT NAME: LEFAMULINE, SELS ET SOLVATES DE CELLE-CI; AUTHORISATION NUMBER AND DATE: EU/1/20/1457 20200728
2137143 CR 2020 00046 Denmark See Plans and Pricing PRODUCT NAME: LEFAMULIN, SALTE OG SOLVATER DERAF; REG. NO/DATE: EU/1/20/1457 20200728
2137143 2020/053 Ireland See Plans and Pricing PRODUCT NAME: LEFAMULIN, SALTS AND SOLVATES THEREOF; NAT REGISTRATION NO/DATE: EU/1/20/1457 20200728; FIRST REGISTRATION NO/DATE: EU/1/20/1457 20200728
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Colorcon
Johnson and Johnson
Dow
McKesson
Merck
Harvard Business School

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.