NDAORALCAPSULE, EXTENDED RELEASE
Approved
Nov 2024
Lifecycle
Growth
Competitive Pressure
0/100
Data completeness
5/8 — Partial
EMROSI (minocycline hydrochloride extended-release) by Journey Medical is 12. Approved for inflammatory lesions (papules, pustules) of rosacea in adults, development of drug-resistant bacteria and 2 more indications. First approved in 2024.
Drug data last refreshed 13h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
EMROSI is an extended-release oral minocycline hydrochloride capsule approved for treating inflammatory lesions (papules and pustules) of rosacea in adults. The mechanism of action for rosacea treatment is unknown, though minocycline is a lipid-soluble tetracycline that distributes into skin and sebum with an elimination half-life of approximately 15 hours.
Growth12.3 years to LOE
Early-stage product with 12.3 years of patent protection represents a growth opportunity for brand teams entering dermatology specialty market.
Mechanism of Action
12.1 Mechanism of Action The mechanism of action of EMROSI for the treatment of rosacea is unknown. 12.2 Pharmacodynamics The pharmacodynamics of EMROSI for the treatment of rosacea are unknown. 12.3 Pharmacokinetics EMROSI is not bioequivalent to any other minocycline products. The…
Indications (5)
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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.