LEFAMULIN ACETATE - Generic Drug Details

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

Constraining patent/regulatory exclusivity:

GENERATING ANTIBIOTIC INCENTIVES NOW

Dosage:

SOLUTION;INTRAVENOUS

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
Mechanism of Action	Acidifying Activity Calcium Chelating Activity
Physiological Effect	Decreased Coagulation Factor Activity

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		DISCN	Yes	No
Nabriva	XENLETA	lefamulin acetate	TABLET;ORAL	211672-001	Aug 19, 2019		RX	Yes	Yes
Nabriva	XENLETA	lefamulin acetate	TABLET;ORAL	211672-001	Aug 19, 2019		RX	Yes	Yes			Y	Y
Nabriva	XENLETA	lefamulin acetate	SOLUTION;INTRAVENOUS	211673-001	Aug 19, 2019		DISCN	Yes	No			Y	Y
Nabriva	XENLETA	lefamulin acetate	TABLET;ORAL	211672-001	Aug 19, 2019		RX	Yes	Yes			Y	Y

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
Nabriva	XENLETA	lefamulin acetate	TABLET;ORAL	211672-001	Aug 19, 2019

International Patents for LEFAMULIN ACETATE

Country	Patent Number	Title	Estimated Expiration
Israel	200440	תולדות פלאורומוטילין לטיפול במחלות המתווכות על ידי מיקרובים (Pleuromutilin derivatives for the treatment of diseases mediated by microbes)
South Korea	101478593
Norway	2021002
European Patent Office	3299356	PROCÉDÉ DE PRÉPARATION DE PLEUROMUTILINES (PROCESS FOR THE PREPARATION OF PLEUROMUTILINS)
Slovenia	3299356

Supplementary Protection Certificates for LEFAMULIN ACETATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2137143	20C1053	France		PRODUCT NAME: LEFAMULINE; NAT. REGISTRATION NO/DATE: EU/1/20/1457 20200728; FIRST REGISTRATION: FR - EU/1/20/1457 20200728
2137143	2090054-4	Sweden		PRODUCT NAME: LEFAMULIN, SALTS AND SOLVATES THEREOF; REG. NO/DATE: EU/1/20/1457 20200728
2137143	CR 2020 00046	Denmark		PRODUCT NAME: LEFAMULIN, SALTE OG SOLVATER DERAF; REG. NO/DATE: EU/1/20/1457 20200728
2137143	C20200039 00365	Estonia		PRODUCT NAME: LEFAMULIIN;REG NO/DATE: EU/1/20/1457 28.07.2020
2137143	2021C/501	Belgium		PRODUCT NAME: LEFAMULINE, ZOUTEN EN SOLVATEN ERVAN; AUTHORISATION NUMBER AND DATE: EU/1/20/1457 20200728