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FLORINEF

NDA

FLUDROCORTISONE ACETATE | N010060 | CASPER PHARMA 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

2 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Amendment to Suitability Petition from Rising Pharma Holdings, Inc. FDA-2024-P-4514 Rising Pharma Holdings, Inc. filed this amendment to suitability petition FDA-2024-P-4514 to seek permission to file an ANDA for Fludrocortisone Acetate Tablets in 0.05 mg, 0.1 mg, and 0.2 mg strengths. The amendment provides proposed product labeling (package inserts) in response to the FDA's Octob	Suitability	2024-10-10	Granted	Rising Pharma Holdings, Inc.
Suitability Petition from Rising Pharma Holdings, Inc FDA-2024-P-4514 Rising Pharma Holdings, Inc. filed a suitability petition under 21 CFR 314.93 requesting FDA approval to submit an Abbreviated New Drug Application for Fludrocortisone Acetate Tablets in 0.05 mg and 0.2 mg strengths, which differ from the reference listed drug Florinef (0.1 mg) and reference standar	Suitability	2024-09-25	Granted	Rising Pharma Holdings, Inc

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

Clinical Trials

18 trials from ClinicalTrials.gov — 2 recruiting, 11 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study of MK-5684 in People With Certain Solid Tumors (MK-5684-015/OMAHA-015)NCT06979596	Phase 2	Recruiting	Merck Sharp & Dohme LLC	250	2025-08-11 → 2027-11-04
Platform of Randomized Adaptive Clinical Trials in Critical Illness NCT05440851	N/A	Recruiting	University Health Network, Toronto	6,250	2023-04-30 → 2027-03-31
Fludrocortisone in Healthy Volunteers (AFLUCO4)NCT02140918	Phase 2	Completed	Rennes University Hospital	16	2014-07-01 → 2016-04-20
Fludrocortisone and Information Processing in Healthy Volunteers NCT01648998	Phase 1	Completed	Leiden University Medical Center	40	2012-05 → 2013-12
Efficacy of Therapeutic Interventions for Orthostatic Hypotension in Parkinson's Disease and Multiple System Atrophy NCT00103597	Phase 1	Completed	Royal Brisbane and Women's Hospital	50	2005-01 → 2005-09
Clinical Trial for the Prevention of Vasovagal Syncope NCT00118482	Phase 4	Completed	University of Calgary	213	2005-05 → 2011-07
Mineralocorticoid Receptor, NMDA Receptor and Cognitive Function in Depression NCT03062150	N/A	Completed	Charite University, Berlin, Germany	232	2016-09-27 → 2019-02-11
Effects of Mineralocorticoid Receptor Stimulation on Cognition NCT02478034	N/A	Completed	Charite University, Berlin, Germany	80	2015-05 → 2016-03
Impact of the Administration of Fludrocortisone in Very Premature Infants NCT03001089	Phase 2	Completed	Assistance Publique - Hôpitaux de Paris	66	2017-06-01 → 2020-09-08
The Role of Minerelocorticoid Receptor on Modulating Aldosterone Production NCT02871648	Phase 1	Completed	Brigham and Women's Hospital	23	2016-01 → 2019-12

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

Medicare Part D Spending

CMS annual spending data for Fludrocortisone Acetate (2024)

Total Spending

$11.9M

Total Claims

497,178

Beneficiaries

119,372

Avg Cost/Unit

$0.39

Spending Trend

$12.8M(2019)→$13.5M(2020)→$12.5M(2021)→$12.6M(2022)→$13.0M(2023)→$11.9M(2024)

YoY Change:-14.8%

5yr CAGR:-4.9%

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

API Supply Chain5 active DMFs1 inactive

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

FARMABIOS SPAFLUDROCORTISONE ACETATE

DMF 141361999

TAPI NL BVFLUDROCORTISONE ACETATE

DMF 147031999

CURIA SPAIN SAUFLUDROCORTISONE ACETATE USP

DMF 210542007

NOVITIUM PHARMA LLCFLUDROCORTISONE ACETATE USP

DMF 349232020

HENAN LIHUA PHARMACEUTICAL CO LTDFLUDROCORTISONE ACETATE

DMF 363672021

MYLAN LABORATORIES LTDInactiveFLUDROCORTISONE ACETATE USP

DMF 229942009

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jun 30, 2004	SUPPL -17	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.