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SODIUM SULAMYD

NDA

SULFACETAMIDE SODIUM | N005963 | SCHERING CORP SUB SCHERING PLOUGH CORP

3 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 Sulfacetamide Sodium* (2023)

Total Spending

$2.1M

Total Claims

31,974

Beneficiaries

23,854

Avg Cost/Unit

$1.93

Spending Trend

$3.5M(2019)→$3.0M(2020)→$2.4M(2021)→$2.4M(2022)→$2.1M(2023)

YoY Change:-5.0%

5yr CAGR:-5.0%

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

API Supply Chain0 active DMFs1 inactive

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

NAPP CHEMICALS INCInactiveSULFACETAMIDE

DMF 44001981

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

Products (3)

Sort:

#001 — 10% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

SOLUTION/DROPS;OPHTHALMIC | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 10% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

OINTMENT;OPHTHALMIC | Approved: Approved Prior to Jan 1, 1982

#003 — 30% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

SOLUTION/DROPS;OPHTHALMIC | Approved: Approved Prior to Jan 1, 1982