Viewing data from:

BAXDELA

NDA

DELAFLOXACIN MEGLUMINE | N208610 | MELINTA SUBSIDIARY CORP

1 strength5 unique patents2 unique exclusivities

Patent Timeline

5 unique patents, 2 exclusivities by expiration date

Expiring < 1yr (2)Active (3)TodayExclusivity

2023

2024

2025

2026

2027

2028

2029

2030

2031

Today

Dec. 28, 2029

Jun. 19, 2031

Oct. 2, 2026

Aug. 6, 2026

Sep. 23, 2029

NCE

Jun. 19, 2022

GAIN

Jun. 19, 2027

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 Baxdela* (2023)

Total Spending

$1.1M

Total Claims

510

Beneficiaries

343

Avg Cost/Unit

$84.24

Spending Trend

$4.4M(2019)→$2.3M(2020)→$1.6M(2021)→$1.4M(2022)→$1.1M(2023)

YoY Change:+0.5%

5yr CAGR:+3.0%

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

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Oct 25, 2019	SUPPL -7	View Letter (PDF)
May 7, 2019	SUPPL -6	View Letter (PDF)
Oct 23, 2018	SUPPL -5	View Letter (PDF)
Jun 19, 2017	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 450MG BASE

RLD

5 patents2 exclusivities▴

TABLET;ORAL | Approved: Jun 19, 2017

Patents (5)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
RE46617	Dec 28, 2029	—	Yes	—	—	—
7728143	Jun 19, 2031	—	Yes	—	—	—
8252813	Oct 2, 2026	—	—	Yes		—
8273892	Aug 6, 2026	—	Yes	—	—	—
8871938	Sep 23, 2029	—	Yes	—	—	—

Exclusivities (2)

Code	Date	Status
GAIN	Jun 19, 2027	< 1 year
NCE	Jun 19, 2022	Expired