NDAORALCAPSULE
Approved
May 2006
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
20
Data completeness
6/8 — Strong
ORACEA (doxycycline) by Galderma is 12. Approved for rosacea, acne vulgaris, syphilis and 6 more indications. First approved in 2006.
Drug data last refreshed 18h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ORACEA is a low-dose doxycycline capsule (40 mg) indicated exclusively for inflammatory lesions (papules and pustules) of rosacea in adult patients. The mechanism of action remains unknown, though doxycycline is a tetracycline-class antibiotic with anti-inflammatory properties. It is administered orally and must be taken on an empty stomach (1 hour before or 2 hours after meals) to avoid significant reductions in absorption.
$0.004BPart D
LOE ApproachingDeclining
1.6 years to LOEProduct approaching patent expiration (1.7 years remaining) with modest Part D revenue signals team consolidation and transition planning.
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.