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BUMEX

NDA

BUMETANIDE | N018225 | VALIDUS PHARMACEUTICALS LLC

3 strengths0 unique patents0 unique exclusivities

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 Bumetanide* (2023)

Total Spending

$98.4M

Total Claims

2,193,078

Beneficiaries

522,275

Avg Cost/Unit

$0.58

Spending Trend

$116.3M(2019)→$119.8M(2020)→$119.3M(2021)→$115.7M(2022)→$98.4M(2023)

YoY Change:-20.5%

5yr CAGR:-9.5%

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

API Supply Chain8 active DMFs2 inactive

8 active API suppliers hold Drug Master Files for this ingredient.

GUILIN PHARMACEUTICAL CO LTDBUMETANIDE USP

DMF 86821990

OLON SPABUMETANIDE

DMF 109941994

INDUSTRIALE CHIMICA SRLBUMETANIDE

DMF 247502011

SOLARA ACTIVE PHARMA SCIENCES LTDBUMETANIDE USP

DMF 332612018

MSN LABORATORIES PRIVATE LTDBUMETANIDE USP

DMF 339152019

HAINAN POLY PHARM CO LTDBUMETANIDE USP

DMF 402722024

MEDILUX LABORATORIES PVT LTDBUMETANIDE USP

DMF 418302025

UNICHEM LABORATORIES LTDBUMETANIDE USP

DMF 420472025

QUIMICA SINTETICA SAInactiveBUMETANIDE

DMF 84351990

LEO PHARMACEUTICAL PRODUCTS LTDInactiveBUMETANIDE PURE MICRONISED

DMF 127021997

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

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Jan 19, 2024	SUPPL -29	View Letter (PDF)
Aug 10, 2018	SUPPL -28	View Letter (PDF)
May 9, 2017	SUPPL -26	View Letter (PDF)
Jan 26, 2010	SUPPL -24	View Letter (PDF)
Jun 8, 2003	SUPPL -22	View Letter (PDF)
Oct 29, 2002	SUPPL -19	View Letter (PDF)
Oct 29, 2002	SUPPL -18	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Feb 28, 1983

No patent or exclusivity listings for this strength.

#002 — 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Feb 28, 1983

#003 — 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jun 14, 1985