NDAORALTABLET, EXTENDED RELEASE
Approved
Oct 1963
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
2/8 — Basic
DISOPHROL (dexbrompheniramine maleate; pseudoephedrine sulfate) by Merck & Co.. Approved for nasal congestion due to the common cold, hay fever, other upper repiratory allergies helps decongest sinus opening and 5 more indications. First approved in 1963.
Drug data last refreshed 3d ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DISOPHROL is an oral extended-release combination tablet containing dexbrompheniramine maleate (antihistamine) and pseudoephedrine sulfate (decongestant), approved in 1963. It treats nasal congestion, hay fever, and upper respiratory allergies by reducing swelling of nasal membranes and shrinking inflamed passages. The antihistamine blocks histamine receptors to reduce allergic symptoms while the decongestant acts on sympathetic receptors to vasoconstrict nasal blood vessels.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30/100), indicating shrinking team and defensive commercial strategy likely focused on cost and legacy patient retention.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications (8)
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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.