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Last Updated: October 26, 2021

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Lefamulin acetate - Generic Drug Details

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What are the generic sources for lefamulin acetate and what is the scope of patent protection?

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

Lefamulin acetate has one hundred and sixteen patent family members in forty-one countries.

Summary for lefamulin acetate
International Patents:116
US Patents:4
Tradenames:1
Applicants:1
NDAs:2
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

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 SOLUTION;INTRAVENOUS 211673-001 Aug 19, 2019 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y Y ⤷  Free Forever Trial
Nabriva XENLETA lefamulin acetate SOLUTION;INTRAVENOUS 211673-001 Aug 19, 2019 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Nabriva XENLETA lefamulin acetate TABLET;ORAL 211672-001 Aug 19, 2019 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Nabriva XENLETA lefamulin acetate TABLET;ORAL 211672-001 Aug 19, 2019 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y Y ⤷  Free Forever Trial
Nabriva XENLETA lefamulin acetate TABLET;ORAL 211672-001 Aug 19, 2019 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Nabriva XENLETA lefamulin acetate TABLET;ORAL 211672-001 Aug 19, 2019 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y Y ⤷  Free Forever Trial
Nabriva XENLETA lefamulin acetate SOLUTION;INTRAVENOUS 211673-001 Aug 19, 2019 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y Y ⤷  Free Forever Trial
>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 ⤷  Free Forever Trial ⤷  Free Forever Trial
Nabriva XENLETA lefamulin acetate TABLET;ORAL 211672-001 Aug 19, 2019 ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for lefamulin acetate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2137143 PA2020531 Lithuania ⤷  Free Forever Trial PRODUCT NAME: LEFAMULINAS, JO DRUSKOS IR SOLVATAI; REGISTRATION NO/DATE: EU/1/20/1457 20200727
2137143 301086 Netherlands ⤷  Free Forever Trial PRODUCT NAME: LEFAMULINE, ALSMEDE ZOUTEN EN SOLVATEN ERVAN; REGISTRATION NO/DATE: EU/1/20/1457 20200728
2137143 2020/053 Ireland ⤷  Free Forever Trial 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
2137143 132020000000167 Italy ⤷  Free Forever Trial PRODUCT NAME: LEFAMULINA SUOI SALI E SOLVATI(XENLETA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1457, 20200728
2137143 54/2020 Austria ⤷  Free Forever Trial PRODUCT NAME: LEFAMULIN, SALZE UND SOLVATE DAVON; REGISTRATION NO/DATE: EU/1/20/1457 (MITTEILUNG) 20200728
2137143 LUC00178 Luxembourg ⤷  Free Forever Trial PRODUCT NAME: LEFAMULINE, SELS ET SOLVATES DE CELLE-CI; AUTHORISATION NUMBER AND DATE: EU/1/20/1457 20200728
2137143 2021C/501 Belgium ⤷  Free Forever Trial PRODUCT NAME: LEFAMULINE, ZOUTEN EN SOLVATEN ERVAN; AUTHORISATION NUMBER AND 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:

McKinsey
Johnson and Johnson
AstraZeneca
Boehringer Ingelheim
Dow
Mallinckrodt

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