Viewing data from:

SULFAMYLON

NDA

MAFENIDE ACETATE | N016763 | RISING PHARMA HOLDINGS INC

1 strength0 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 Sulfamylon (2023)

Total Spending

$52K

Total Claims

391

Beneficiaries

268

Avg Cost/Unit

$1.26

Spending Trend

$16K(2021)→$51K(2022)→$52K(2023)

YoY Change:+6.9%

5yr CAGR:+5.6%

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

API Supply Chain3 active DMFs

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

MATRIX PHARMACORP PRIVATE LTDMAFENIDE ACETATE USP

DMF 246152011

PH HEALTH LTDMAFENIDE ACETATE USP

DMF 247222011

MATRIX PHARMACORP PRIVATE LTDMAFENIDE ACETATE USP

DMF 322922017

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

Products (1)

#001 — EQ 85MG BASE/GM

RLD

0 patents0 exclusivities▴

CREAM;TOPICAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.