NDAORALCAPSULE, EXTENDED RELEASE
Approved
Jul 2012
Lifecycle
LOE Approaching
Competitive Pressure
25/100
Clinical Trials
1
Data completeness
5/8 — Partial
XIMINO (minocycline hydrochloride) by Journey Medical 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 2012.
Drug data last refreshed 18m ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
XIMINO is an extended-release oral capsule formulation of minocycline hydrochloride, a tetracycline-class antibiotic that inhibits bacterial protein synthesis. It is indicated for treatment of a broad spectrum of gram-positive and gram-negative bacterial infections, including respiratory tract infections, skin infections, and sexually transmitted infections. The drug achieves peak serum concentrations in 1-4 hours with an average half-life of 15.5 hours, allowing for convenient dosing with or without food.
$0.035BPart D
LOE Approaching9mo to LOEProduct approaching loss of exclusivity with minimal Part D penetration and low claim volume, indicating a small, specialized or mature market requiring defensive commercial strategy.
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.