NDAORALCAPSULE, EXTENDED RELEASE
Approved
Jul 2012
Lifecycle
LOE Approaching
Competitive Pressure
25/100
Clinical Trials
1
Data completeness
6/8 — Strong
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. Approved for acute ischemic stroke, rosacea, peripheral neuropathy and 3 more indications. First approved in 2012.
Drug data last refreshed 21h ago · AI intelligence enriched 2w 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 acute ischemic stroke, rosacea, peripheral neuropathy, traumatic brain injury, breast cancer, and acute pain. The drug achieves peak serum concentrations in 1-4 hours with an average half-life of 15.5 hours and demonstrates activity against a broad spectrum of gram-positive and gram-negative organisms.
$0.035BPart D
LOE Approaching11mo to LOEProduct is approaching loss of exclusivity in April 2027 with minimal current Part D utilization, indicating a niche market with limited team expansion opportunities.
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.