Lefamulin acetate - Generic Drug Details
✉ Email this page to a colleague
▶ Start for $1
Remove trial restrictions
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
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 |
