NDAORALCAPSULE
Approved
Dec 1989
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
2
Data completeness
3/8 — Basic
MONODOX (doxycycline monohydrate) by Molecular Devices is clinical pharmacology tetracyclines are readily absorbed and are bound to plasma proteins in varying degrees. First approved in 1989.
Drug data last refreshed 7h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
MONODOX (doxycycline monohydrate) is an oral tetracycline-class antibiotic approved in 1989 that inhibits bacterial protein synthesis by binding to the 30S ribosomal subunit. It is indicated for bacterial infections caused by a broad range of Gram-positive and Gram-negative organisms and is administered via oral capsule. The drug demonstrates virtually complete absorption with a serum half-life of approximately 16 hours and is excreted primarily through renal and hepatic pathways.
LOE Approaching
Product is approaching loss of exclusivity with moderate competitive pressure (30/100), signaling a consolidating brand team focused on generic defense and niche positioning.
Mechanism of Action
CLINICAL PHARMACOLOGY Tetracyclines are readily absorbed and are bound to plasma proteins in varying degrees. They are concentrated by the liver in the bile and excreted in the urine and feces at high concentrations in a biologically active form. Doxycycline is virtually completely absorbed after…
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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.