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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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Baker Hostetler, LLP FDA-2015-P-1090 · 7 docket documents Baker Hostetler LLP, on behalf of an unnamed client, filed this petition under 21 U.S.C. § 505 requesting that the FDA declare New Drug Application 17-351 for Cortifoam (hydrocortisone acetate) was not validly approved and should be withdrawn from the market because the application never satisfied s	Other	2015-08-18	Denied	Baker Hostetler, LLP

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

Clinical Trials

297 trials from ClinicalTrials.gov — 7 recruiting, 13 active, 194 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
ASIA Down Syndrome Acute Lymphoblastic Leukemia 2016 NCT03286634	Phase 2	Active	National Hospital Organization Nagoya Medical Center	60	2017-04-18 → 2033-03-31
177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu-J591) and Ketoconazole in Patients With Prostate Cancer NCT00859781	Phase 2	Active	Weill Medical College of Cornell University	55	2009-06 → 2026-09
Blinatumomab in Treating Younger Patients With Relapsed B-cell Acute Lymphoblastic Leukemia NCT02101853	Phase 3	Active	National Cancer Institute (NCI)	669	2014-12-17 → 2026-09-16
Hormonal Mechanisms of Sleep Restriction - Axis Study NCT03142893	Phase 1	Active	Peter y. Liu	80	2017-05-08 → 2026-06-30
Intravenous (IV) Hydrocortisone for TKA (Total Knee Arthroplasty)NCT04082533	Phase 4	Active	Hospital for Special Surgery, New York	132	2019-07-24 → 2026-05
HYPAR Trial - Hydrocortisone vs. Pasireotide in Reducing Pancreatic Surgery Complications NCT02775227	Phase 4	Active	Helsinki University Central Hospital	126	2016-05 → 2029-12
Total Therapy for Infants With Acute Lymphoblastic Leukemia (ALL) I NCT02553460	Phase 1/2	Active	St. Jude Children's Research Hospital	50	2016-01-29 → 2031-10
Hormonal Mechanisms of Sleep Restriction - Axis Study in Older Men and Postmenopausal Women NCT04037605	Early Phase 1	Active	Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center	5	2020-02-09 → 2026-06-24
A Trial of Epigenetic Priming in Patients With Newly Diagnosed Acute Myeloid Leukemia NCT03164057	Phase 2	Active	St. Jude Children's Research Hospital	206	2017-06-15 → 2027-06
Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia NCT03007147	Phase 3	Active	Children's Oncology Group	475	2017-08-08 → 2027-09-30

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$30.69

per gm

Lowest NADAC/Unit

$30.69

per gm

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00037683015CORTIFOAM 10% AEROSOL	$30.69	GM	Brand	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$320.19

Highest Price

$320.19

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00037-6830-15CORTIFOAM 10%	$320.19	FSS	Mylan Specialty L.P.	01/14/2027
00037-6830-15CORTIFOAM 10%	$320.19	Big4	Mylan Specialty L.P.	01/14/2027

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Cortifoam (2024)

Total Spending

$507K

Total Claims

821

Beneficiaries

434

Avg Cost/Unit

$28.02

Spending Trend

$8K(2019)→$10K(2020)→$258K(2021)→$412K(2022)→$528K(2023)→$507K(2024)

YoY Change:-2.2%

5yr CAGR:+0.7%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain5 active DMFs6 inactive

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

PHARMACIA AND UPJOHN CO WHOLLY OWNED SUB PFIZER INCHYDROCORTISONE ACETATE USP, MICRO & NON-MICRO

DMF 54981984

HENAN LIHUA PHARMACEUTICAL CO LTDHYDROCORTISONE ACETATE

DMF 296852015

SYMBIOTEC PHARMALAB 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.