ROFLUMILAST

Post-LOE

roflumilast

Aurobindo Pharma

ANDAORALTABLET

Approved

Apr 2023

Lifecycle

Post-LOE

Competitive Pressure

30/100

Clinical Trials

Data completeness

5/8 — Partial

ROFLUMILAST (roflumilast) by Aurobindo Pharma is phosphodiesterase 4 inhibitors [moa]. Approved for copd. First approved in 2023.

$0.0BPart D

Mechanism of Action

Phosphodiesterase 4 Inhibitors

Pharmacologic Class:

Phosphodiesterase 4 Inhibitor

Indications (1)

COPD

Clinical Trials (20)

NCT07077902Phase 2Recruiting

A Study for Evaluating Safety & Efficacy of Topical Roflumilast 0.3% Foam in Hidradenitis Suppurativa

Started Sep 2025

10 enrolled

Hidradenitis Suppurativa

NCT07105254Phase 2Recruiting

An Open-label Single Center, Proof of Concept Study Evaluating the Efficacy of Roflumilast Foam 0.3% in Pediatric Patients With Non-Segmental Vitiligo (NSV)

Started Aug 2025

20 enrolled

Non-segmental Vitiligo

NCT06998056Phase 2Completed

Safety Study of Roflumilast Cream 0.05% in Infants Aged 3 Months to Less Than 2 Years With Atopic Dermatitis

Started Jun 2025

101 enrolled

Atopic Dermatitis (Eczema)

NCT05682859Phase 4Unknown

Treatment of Chronic Hand Eczema With Oral Roflumilast (HERO)

Started Sep 2023

40 enrolled

Chronic Hand Eczema

NCT05028582Phase 3Completed

Topical Roflumilast to Treat Scalp and Body Psoriasis (ARRECTOR)

Started Aug 2021

432 enrolled

Scalp Psoriasis

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Data Sources

Drug label: DailyMed / FDA
Clinical trials: ClinicalTrials.gov
Patent data: FDA Orange Book
Spending data: CMS Medicare

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.