Viewing data from:

EDECRIN

NDA

ETHACRYNIC ACID | N016092 | BAUSCH HEALTH AMERICAS INC

2 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 Edecrin (2023)

Total Spending

$517K

Total Claims

229

Beneficiaries

Avg Cost/Unit

$25.30

Spending Trend

$1.4M(2019)→$921K(2020)→$766K(2021)→$676K(2022)→$517K(2023)

YoY Change:+0.2%

5yr CAGR:+1.0%

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

API Supply Chain10 active DMFs2 inactive

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

EGIS PHARMACEUTICALS PLCETHACRYNIC ACID

DMF 171932004

ZYDUS LIFESCIENCES LTDETHACRYNIC ACID USP

DMF 256472012

TOPCHEM PHARMACEUTICALS LTDETHACRYNIC ACID

DMF 259362012

OLON SPAETHACRYNIC ACID

DMF 259732012

MATRIX PHARMACORP PRIVATE LTDETHACRYNIC ACID USP

DMF 260132012

CHEMWERTH INCETHACRYNIC ACID USP NON-STERILE BULK DRUG

DMF 263372013

BRECKENRIDGE PHARMACEUTICAL INCETHACRYNIC ACID USP

DMF 274732013

BIOPHORE INDIA PHARMACEUTICALS PVT LTDETHACRYNIC ACID

DMF 294292015

SOLARA ACTIVE PHARMA SCIENCES LTDETHACRYNIC ACID USP

DMF 320692017

EMCURE PHARMACEUTICALS LTDETHACRYNIC ACID USP

DMF 324272018

EGIS PHARMACEUTICALS PRIVATE LTDInactiveETHACRYNIC ACID

DMF 74111988

SUNNY PHARMTECH INCInactiveETHACRYNIC ACID USP

DMF 319252017

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Feb 11, 2005	SUPPL -42	View Letter (PDF)
Mar 2, 2004	SUPPL -39	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 25MG

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 50MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982