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Last Updated: April 22, 2024

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 three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Lefamulin acetate has eighty-seven 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

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

Supplementary Protection Certificates for lefamulin acetate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2137143 54/2020 Austria ⤷  Try a Trial PRODUCT NAME: LEFAMULIN, SALZE UND SOLVATE DAVON; REGISTRATION NO/DATE: EU/1/20/1457 (MITTEILUNG) 20200728
2137143 SPC/GB20/052 United Kingdom ⤷  Try a Trial PRODUCT NAME: LEFAMULIN, OPTIONALLY IN THE FORM OF A SALT AND/OR SOLVATE THEREOF; REGISTERED: UK EU/1/20/1457 (NI) 20200728; UK PLGB 53672/0001 20200728; UK PLGB 53672/0002 20200728
2137143 CA 2020 00046 Denmark ⤷  Try a Trial PRODUCT NAME: LEFAMULIN, SALTE OG SOLVATER DERAF; REG. NO/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.