Viewing data from:

ENBUMYST

NDA

BUMETANIDE | N219500 | CORSTASIS THERAPEUTICS INC

1 strength4 unique patents0 unique exclusivities

Patent Timeline

4 unique patents by expiration date

Active (4)Today

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Today

Dec. 4, 2040

Dec. 4, 2040

Dec. 4, 2040

May. 14, 2045

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

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

1 letter from Drugs@FDA

Date	Submission	Document
Sep 15, 2025	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.5MG/SPRAY

RLD

4 patents0 exclusivities▴

SPRAY;NASAL | Approved: Sep 12, 2025

Patents (4)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
11123319	Dec 4, 2040	—	—	Yes	—	—
11260038	Dec 4, 2040	—	—	—		—
12329731	Dec 4, 2040	—	—	Yes		—
12558330	May 14, 2045	—	—	Yes		—