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

Lefamulin acetate has one hundred and sixteen patent family members in forty-one countries.

Summary for lefamulin acetate

International Patents:	116
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	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

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		RX	Yes	Yes			Y	Y
Nabriva	XENLETA	lefamulin acetate	SOLUTION;INTRAVENOUS	211673-001	Aug 19, 2019		RX	Yes	Yes
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	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		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	Estimated Expiration
Hungary	E035861
Norway	20030100
Netherlands	301086
Slovenia	2137143
Japan	2010522143
Poland	358674
Hungary	S2100001

Supplementary Protection Certificates for lefamulin acetate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2137143	PA2020531	Lithuania		PRODUCT NAME: LEFAMULINAS, JO DRUSKOS IR SOLVATAI; REGISTRATION NO/DATE: EU/1/20/1457 20200727
2137143	301086	Netherlands		PRODUCT NAME: LEFAMULINE, ALSMEDE ZOUTEN EN SOLVATEN ERVAN; REGISTRATION NO/DATE: EU/1/20/1457 20200728
2137143	2020/053	Ireland		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	132020000000167	Italy		PRODUCT NAME: LEFAMULINA SUOI SALI E SOLVATI(XENLETA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1457, 20200728
2137143	54/2020	Austria		PRODUCT NAME: LEFAMULIN, SALZE UND SOLVATE DAVON; REGISTRATION NO/DATE: EU/1/20/1457 (MITTEILUNG) 20200728
2137143	LUC00178	Luxembourg		PRODUCT NAME: LEFAMULINE, SELS ET SOLVATES DE CELLE-CI; AUTHORISATION NUMBER AND DATE: EU/1/20/1457 20200728
2137143	2021C/501	Belgium		PRODUCT NAME: LEFAMULINE, ZOUTEN EN SOLVATEN ERVAN; AUTHORISATION NUMBER AND DATE: EU/1/20/1457 20200728