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 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

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			Y	Y
Nabriva	XENLETA	lefamulin acetate	SOLUTION;INTRAVENOUS	211673-001	Aug 19, 2019		RX	Yes	Yes

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
Spain	2620459
Taiwan	I585073
Australia	2008229609	Pleuromutilin derivatives for the treatment of diseases mediated by microbes
Denmark	2137143

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	LUC00178	Luxembourg		PRODUCT NAME: LEFAMULINE, SELS ET SOLVATES DE CELLE-CI; AUTHORISATION NUMBER AND DATE: EU/1/20/1457 20200728
2137143	SPC/GB20/052	United Kingdom		PRODUCT NAME: LEFAMULIN, OPTIONALLY IN THE FORM OF A SALT AND/OR SOLVATE THEREOF; REGISTERED: UK EU/1/20/1457 (NI) 20200728; UK PLGB 53672/0001 20200728; UK PLGB 53672/0002 20200728
2137143	132020000000167	Italy		PRODUCT NAME: LEFAMULINA SUOI SALI E SOLVATI(XENLETA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1457, 20200728