NDAORALCAPSULE
Approved
May 2006
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
20
Data completeness
5/8 — Partial
ORACEA (doxycycline) by Galderma is 12. First approved in 2006.
Drug data last refreshed 5h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ORACEA is a low-dose (40 mg) oral doxycycline capsule approved in 2006 for the treatment of inflammatory lesions of rosacea. The exact mechanism of action in rosacea is unknown, though doxycycline is a tetracycline-class antibiotic with anti-inflammatory properties. ORACEA is pharmacokinetically distinct from other doxycycline formulations and has specific food-effect requirements.
$4MPart D
LOE ApproachingDeclining
1.5 years to LOEModest Part D uptake ($4M, 3,150 claims in 2023) signals niche positioning; team likely focused on retention and off-label expansion before LOE in late 2027.
Mechanism of Action
12.1 Mechanism of Action The mechanism of action of ORACEA in the treatment of inflammatory lesions of rosacea is unknown. 12.3 Pharmacokinetics ORACEA capsules are not bioequivalent to other doxycycline products. The pharmacokinetics of doxycycline following oral administration of ORACEA was…
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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.