Viewing data from:

XENLETA

NDA

LEFAMULIN ACETATE | N211672 | HONG KONG KING FRIEND INDUSTRIAL CO LTD

1 strength3 unique patents2 unique exclusivities

Patent Timeline

3 unique patents, 2 exclusivities by expiration date

Active (3)TodayExclusivity

2025

2026

2027

2028

2029

2030

2031

2032

2033

Today

8071643

Mar. 25, 2033

8153689

Mar. 19, 2028

9120727

May. 23, 2031

NCE

Aug. 19, 2024

GAIN

Aug. 19, 2029

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Xenleta* (2023)

Total Spending

$40K

Total Claims

Beneficiaries

Avg Cost/Unit

$143.44

Spending Trend

$76K(2020)→$121K(2021)→$68K(2022)→$40K(2023)

YoY Change:+0.9%

5yr CAGR:+3.7%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Mar 17, 2021	SUPPL -2	View Letter (PDF)
Oct 13, 2020	SUPPL -1	View Letter (PDF)
Aug 20, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 600MG BASE

RLD

3 patents2 exclusivities▴

TABLET;ORAL | Approved: Aug 19, 2019

Patents (3)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8071643	Mar 25, 2033	—	Yes	Yes	—	—
8153689	Mar 19, 2028	—	Yes	Yes	—	—
9120727	May 23, 2031	—	Yes	Yes	—	—

Exclusivities (2)

Code	Date	Status
GAIN	Aug 19, 2029	Active
NCE	Aug 19, 2024	Expired