NDAORALTABLET
Approved
Sep 1964
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
DECLOMYCIN (demeclocycline hydrochloride) by Pfizer is clinical pharmacology pharmacokinetics the absorption of demeclocycline is slower than that of tetracycline. Approved for infections caused by the following gram-negative microorganisms, bacteriologic testing indicates appropriate susceptibility to the drug: escherichia coli, infections caused by the following gram-positive microorganisms and 7 more indications. First approved in 1964.
Drug data last refreshed 7h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DECLOMYCIN (demeclocycline hydrochloride) is an oral tetracycline antibiotic approved in 1964 that treats infections caused by susceptible gram-positive and gram-negative bacteria, including rickettsial infections such as Rocky Mountain spotted fever and Q fever. It works by inhibiting bacterial protein synthesis, making it bacteriostatic. The drug has slower absorption than tetracycline with a serum half-life of 10–16 hours and reduced renal clearance compared to other tetracyclines.
LOE Approaching
Product is approaching loss of exclusivity with modest competitive pressure (30%), signaling a consolidating team and transition toward generic defense strategies.
Mechanism of Action
CLINICAL PHARMACOLOGY Pharmacokinetics The absorption of demeclocycline is slower than that of tetracycline. The time to reach the peak concentration is about 4 hours. After a 150 mg oral dose of demeclocycline tablet, the mean concentrations at 1 hour and 3 hours are 0.46 and 1.22 mcg/mL (n = 6),…
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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.