Question 1

Is there a generic for Lefamulin acetate?

Accepted Answer

The FDA Orange Book does not currently list an approved generic (ANDA) for Lefamulin acetate. It is available as 2 brand (NDA) applications.

Question 2

What is the reference-listed drug for Lefamulin acetate?

Accepted Answer

XENLETA (NDA 211673, HONG KONG) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Lefamulin acetate?

Accepted Answer

The Orange Book lists 4 patents against Lefamulin acetate products, with the earliest listed expiry in 2028. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Question 4

Does Lefamulin acetate have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 4 marketing-exclusivity periods for Lefamulin acetate. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

Question 5

What dosage forms of Lefamulin acetate are approved?

Accepted Answer

Lefamulin acetate is approved in the following dosage forms: solution, tablet.

Product	Applicant	Application	TE	Approved
XENLETARLD	HONG KONG	NDA 211673	—	Aug 19, 2019
XENLETARLD	HONG KONG	NDA 211672	—	Aug 19, 2019

Patent	Expires	In	Type
8153689	Mar 19, 2028	in 1 yr 9 mo	SubstanceProduct
9120727	May 23, 2031	in 5 yr	SubstanceProduct
8071643	Mar 25, 2033	in 6 yr 10 mo	SubstanceProduct
12121582	Jun 14, 2036	in 10 yr 2 mo	Product

Lefamulin acetate

Brand (NDA) products · solution, tablet

Marketing exclusivity (4)

Listed patents (4)

Lefamulin acetate — frequently asked questions

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