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^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: GENERATING ANTIBIOTIC INCENTIVES NOW Dosage: SOLUTION;INTRAVENOUS
Generic Entry Dates for lefamulin acetate^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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

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

J01XX	Other antibacterials
J01X	OTHER ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for lefamulin acetate

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Glossary

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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
>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

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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

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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
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for lefamulin acetate

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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
>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.

Summary for lefamulin acetate

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for lefamulin acetate

Pharmacology for lefamulin acetate

Anatomical Therapeutic Chemical (ATC) Classes for lefamulin acetate

Make Better Decisions: Try a trial or see plans & pricing

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for lefamulin acetate