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DICHLORPHENAMIDE

ANDA

DICHLORPHENAMIDE | A218783 | RISING PHARMA HOLDINGS INC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: KEVEYIS(TE code: AB)

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Taro Research Institute FDA-2006-P-0447 · 8 docket documents Taro Pharmaceuticals U.S.A., Inc. filed this citizen petition on April 12, 2006, requesting that the FDA determine ANDA suitability for Dichlorphenamide Tablets USP, 50 mg, based on Merck's discontinued reference-listed drug Daranide Tablets, 50 mg, which was voluntarily withdrawn in May 2003 for re	Other	2008-07-10	Granted	Taro Research Institute

Source: Regulations.gov. FDA citizen petitions matched by application number.

Medicare Part D Spending

CMS annual spending data for Dichlorphenamide (2024)

Total Spending

$723K

Total Claims

Beneficiaries

Avg Cost/Unit

$236.16

Spending Trend

$452K(2023)→$723K(2024)

YoY Change:-3.5%

5yr CAGR:-3.5%

Source: CMS Medicare Part D Spending by Drug (2024). 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.

Products (1)

#001 — 50MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Nov 18, 2025

No patent or exclusivity listings for this strength.