Viewing data from:

SIRTURO

NDA

BEDAQUILINE FUMARATE | N204384 | JANSSEN THERAPEUTICS DIV JANSSEN PRODUCTS LP

2 strengths2 unique patents4 unique exclusivities

Patent Timeline

2 unique patents, 4 exclusivities by expiration date

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

2027

2028

2029

Today

7498343

Dec. 1, 2026

8546428

Mar. 19, 2029

ODE-251

Aug. 9, 2026

ODE*

Aug. 9, 2026

ODE-307

May. 27, 2027

M-306

Jun. 21, 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 Sirturo (2023)

Total Spending

$3.0M

Total Claims

645

Beneficiaries

105

Avg Cost/Unit

$163.77

Spending Trend

$980K(2019)→$1.6M(2020)→$2.0M(2021)→$2.1M(2022)→$3.0M(2023)

YoY Change:-0.4%

5yr CAGR:+0.3%

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

API Supply Chain2 active DMFs

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

MSN LIFE SCIENCES PRIVATE LTDBEDAQUILINE FUMARATE

DMF 332682018

MATRIX PHARMACORP PRIVATE LTDBEDAQUILINE FUMARATE

DMF 354262020

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

14 letters from Drugs@FDA

Date	Submission	Document
Jul 29, 2025	SUPPL -20	View Letter (PDF)
Jun 24, 2024	SUPPL -19	View Letter (PDF)
Oct 13, 2023	SUPPL -17	View Letter (PDF)
Sep 27, 2021	SUPPL -16	View Letter (PDF)
May 29, 2020	SUPPL -13	View Letter (PDF)
Jan 7, 2020	SUPPL -14	View Letter (PDF)
Dec 4, 2019	SUPPL -11	View Letter (PDF)
Aug 16, 2019	SUPPL -12	View Letter (PDF)
Aug 13, 2019	SUPPL -10	View Letter (PDF)
Dec 10, 2015	SUPPL -6	View Letter (PDF)
May 19, 2015	SUPPL -5	View Letter (PDF)
Oct 22, 2014	SUPPL -4	View Letter (PDF)
Aug 29, 2013	SUPPL -2	View Letter (PDF)
Jan 2, 2013	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 100MG BASE

RLD

2 patents3 exclusivities▴

TABLET;ORAL | Approved: Dec 28, 2012

Patents (2)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7498343	Dec 1, 2026	—	Yes	Yes		—
8546428	Mar 19, 2029	—	Yes	Yes		—

Exclusivities (3)

Code	Date	Status
M-306	Jun 21, 2027	< 1 year
ODE-251	Aug 9, 2026	< 1 year
ODE-307	May 27, 2027	< 1 year

#002 — EQ 20MG BASE

RLD

2 patents3 exclusivities▾

TABLET;ORAL | Approved: May 27, 2020