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DARANIDE

NDA

DICHLORPHENAMIDE | N011366 | XERIS PHARMACEUTICALS 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 Keveyis (2023)

Total Spending

$20.7M

Total Claims

808

Beneficiaries

Avg Cost/Unit

$343.97

Spending Trend

$354K(2022)→$20.7M(2023)

YoY Change:+12.1%

5yr CAGR:+12.1%

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

API Supply Chain4 active DMFs1 inactive

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

TARO PHARMACEUTICAL INDUSTRIES LTDDICHLORPHENAMIDE USP

DMF 266642013

APITORIA PHARMA PRIVATE LTDDICHLORPHENAMIDE USP

DMF 328612018

NOVITIUM PHARMA LLCDICHLORPHENAMIDE USP

DMF 343712019

BIOPHORE INDIA PHARMACEUTICALS PVT LTDDICHLORPHENAMIDE USP

DMF 352032020

STEROID SRLInactiveDICHLORPHENAMIDE (1,2 DICHLOR 3,5 DISULPHONAMIDO BENZENE)

DMF 32641978

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Nov 22, 2019	SUPPL -33	View Letter (PDF)
Aug 10, 2015	SUPPL -30	View Letter (PDF)
Mar 19, 2012	SUPPL -28	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.

#002 — 50MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Aug 7, 2015