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-seven patent family members in thirty-four countries.
One supplier is listed for this compound.
Summary for LEFAMULIN ACETATE
| International Patents: | 87 |
| US Patents: | 3 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 22 |
| Patent Applications: | 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 |
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 |
*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
| Drug Class | Anti-coagulant Calculi Dissolution Agent Pleuromutilin Antibacterial |
| Mechanism of Action | Acidifying Activity Calcium Chelating Activity Cytochrome P450 3A Inhibitors Cytochrome P450 3A4 Inhibitors |
| Physiological Effect | Decreased Coagulation Factor Activity |
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 | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Nabriva | XENLETA | lefamulin acetate | SOLUTION;INTRAVENOUS | 211673-001 | Aug 19, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Nabriva | XENLETA | lefamulin acetate | SOLUTION;INTRAVENOUS | 211673-001 | Aug 19, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Nabriva | XENLETA | lefamulin acetate | TABLET;ORAL | 211672-001 | Aug 19, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Nabriva | XENLETA | lefamulin acetate | SOLUTION;INTRAVENOUS | 211673-001 | Aug 19, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| >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 | ⤷ Sign Up | ⤷ Sign Up |
| Nabriva | XENLETA | lefamulin acetate | TABLET;ORAL | 211672-001 | Aug 19, 2019 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for LEFAMULIN ACETATE
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| New Zealand | 603804 | Process for the preparation of pleuromutilins | ⤷ Sign Up |
| Eurasian Patent Organization | 200970868 | ПРОИЗВОДНЫЕ ПЛЕВРОМУТИЛИНА ДЛЯ ЛЕЧЕНИЯ ЗАБОЛЕВАНИЙ, ОПОСРЕДУЕМЫХ МИКРОБАМИ | ⤷ Sign Up |
| Taiwan | I585073 | ⤷ Sign Up | |
| Poland | 2576505 | ⤷ Sign Up | |
| Spain | 2909198 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for LEFAMULIN ACETATE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2137143 | 132020000000167 | Italy | ⤷ Sign Up | PRODUCT NAME: LEFAMULINA SUOI SALI E SOLVATI(XENLETA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1457, 20200728 |
| 2137143 | PA2020531 | Lithuania | ⤷ Sign Up | PRODUCT NAME: LEFAMULINAS, JO DRUSKOS IR SOLVATAI; REGISTRATION NO/DATE: EU/1/20/1457 20200727 |
| 2137143 | LUC00178 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: LEFAMULINE, SELS ET SOLVATES DE CELLE-CI; AUTHORISATION NUMBER AND DATE: EU/1/20/1457 20200728 |
| 2137143 | 2020/053 | Ireland | ⤷ Sign Up | 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 | 20C1053 | France | ⤷ Sign Up | PRODUCT NAME: LEFAMULINE; NAT. REGISTRATION NO/DATE: EU/1/20/1457 20200728; FIRST REGISTRATION: FR - 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.
ISSN: 2162-2639
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