Viewing data from:

LITHOSTAT

NDA

ACETOHYDROXAMIC ACID | N018749 | MISSION PHARMACAL CO

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 Lithostat (2023)

Total Spending

$572K

Total Claims

1,238

Beneficiaries

203

Avg Cost/Unit

$6.85

Spending Trend

$835K(2019)→$743K(2020)→$973K(2021)→$702K(2022)→$572K(2023)

YoY Change:-49.1%

5yr CAGR:-21.9%

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

API Supply Chain1 active DMF2 inactive

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

PMC ISOCHEMACETOHYDROXAMIC ACID

DMF 61701985

SIGMA F AND D DIV LTDInactiveACETOHYDROXAMIC ACID

DMF 39381980

EASTMAN KODAK COInactiveACETOHYDROXAMIC ACID (LITHOSTAT)PROCESSED ROCHESTER, N.Y. FACILITIES

DMF 50991983

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

Products (1)

#001 — 250MG

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: May 31, 1983

No patent or exclusivity listings for this strength.