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 20h ago · AI intelligence enriched 4d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ORACEA is an oral capsule formulation of doxycycline 40 mg, a tetracycline-class antibiotic approved by FDA in 2006 for treatment of inflammatory lesions of rosacea. The mechanism of action in rosacea is unknown, though doxycycline's anti-inflammatory properties are leveraged at sub-antimicrobial doses. It is administered orally and must be taken on an empty stomach to optimize absorption.
$0.004BPart D
LOE Approaching1.2 years to LOEProduct is approaching loss of exclusivity with modest Part D utilization (~3,150 claims annually), indicating a mature, niche specialty dermatology product with limited team growth opportunities.
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.