NDAINJECTIONINJECTABLE
Approved
Oct 1972
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
1
Data completeness
4/8 — Partial
MINOCIN (minocycline hydrochloride) by Pfizer is clinical pharmacology following a single dose of minocin 200 mg administered intravenously to 10 healthy male subjects, serum concentrations of minocycline ranged from 2. First approved in 1972.
Drug data last refreshed 3h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
MINOCIN (minocycline hydrochloride) is a tetracycline-class antibiotic administered by intravenous injection that works by inhibiting bacterial protein synthesis. It has broad-spectrum activity against Gram-positive and Gram-negative bacteria, as well as atypical organisms including Chlamydia, Mycoplasma, and Rickettsia. The drug is indicated for serious infections where oral therapy is not feasible or appropriate.
Peak6.3 years to LOE
MINOCIN is a mature, established IV antibiotic facing an approaching loss of exclusivity with modest team requirements focused on hospital formulary management and infectious disease support.
Mechanism of Action
CLINICAL PHARMACOLOGY Following a single dose of Minocin 200 mg administered intravenously to 10 healthy male subjects, serum concentrations of minocycline ranged from 2.52 to 6.63 mcg/mL (average 4.18 mcg/mL) at the end of infusion and 0.82 to 2.64 mcg/mL (average 1.38 mcg/mL) after 12 hours. In a…
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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.