Viewing data from:

CORTIFOAM

NDA

HYDROCORTISONE ACETATE | N017351 | VIATRIS SPECIALTY LLC

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 Cortifoam (2023)

Total Spending

$528K

Total Claims

799

Beneficiaries

430

Avg Cost/Unit

$28.65

Spending Trend

$8K(2019)→$10K(2020)→$258K(2021)→$412K(2022)→$528K(2023)

YoY Change:+0.6%

5yr CAGR:+1.1%

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

API Supply Chain4 active DMFs6 inactive

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

HENAN LIHUA PHARMACEUTICAL CO LTDHYDROCORTISONE ACETATE

DMF 296852015

SYMBIOTEC PHARMALAB PRIVATE LTDHYDROCORTISONE ACETATE USP

DMF 308202016

JIANGSU LIANHUAN PHARMACEUTICAL CO LTDHYDROCORTISONE ACETATE

DMF 361202021

SHANDONG XINHUA PHARMACEUTICAL CO LTDHYDROCORTISONE ACETATE

DMF 376532022

PASADENA RESEARCH LABORATORIES INCInactiveHYDROCORTISONE ACETATE

DMF 1171953

SANOFI CHIMIEInactiveHYDROCORTISONE ACETATE

DMF 35701979

SCHERING AGInactiveHYDROCORTISONE ACETATE

DMF 47451982

QUATRUMInactiveHYDROCORTISONE ACETATE

DMF 67861987

SHANDONG XINHUA PHARMACEUTICAL CO LTDInactiveHYDROCORTISONE ACETATE

DMF 172632004

YANGZHOU PHARMACEUTICAL CO LTDInactiveHYDROCORTISONE ACETATE

DMF 321352017

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Mar 4, 2024	SUPPL -41	View Letter (PDF)
Dec 11, 2003	SUPPL -30	View Letter (PDF)
Jul 8, 2002	SUPPL -27	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 10%

RLD

0 patents0 exclusivities▴

AEROSOL, METERED;RECTAL | Approved: Feb 10, 1982

No patent or exclusivity listings for this strength.