NDAORALTABLET
Approved
Aug 1982
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
3/8 — Basic
MINOCYCLINE HYDROCHLORIDE (minocycline hydrochloride) by Fosun Pharma is clinical pharmacology following a single dose of two minocycline hydrochloride capsules, 100 mg administered to 18 normal fasting adult volunteers, maximum serum concentrations were attained in 1 to 4 hours (average 2. First approved in 1982.
Drug data last refreshed 5d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Minocycline hydrochloride is an oral tetracycline antibiotic indicated for rosacea, a chronic inflammatory skin condition. It works by inhibiting bacterial protein synthesis and has activity against gram-positive and gram-negative organisms, with a half-life of 11-22 hours in normal volunteers. The drug achieves peak serum concentrations in 1-4 hours and may be taken with or without food.
LOE Approaching
As a 40+ year-old drug approaching loss of exclusivity with moderate competitive pressure (30%), the brand team is likely consolidating support and transitioning to defensive positioning rather than growth initiatives.
Mechanism of Action
CLINICAL PHARMACOLOGY Following a single dose of two minocycline hydrochloride capsules, 100 mg administered to 18 normal fasting adult volunteers, maximum serum concentrations were attained in 1 to 4 hours (average 2.1 hours) and ranged from 2.1 to 5.1 mcg/mL (average 3.5 mcg/mL). The serum…
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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.