NDAORALSUSPENSION, EXTENDED RELEASE
Approved
Mar 2013
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Data completeness
4/8 — Partial
KARBINAL ER (carbinoxamine maleate) by Aytu BioPharma is 12. First approved in 2013.
Drug data last refreshed 3h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
KARBINAL ER is an extended-release oral suspension containing carbinoxamine maleate, a first-generation H1 receptor antagonist with anticholinergic and sedative properties. It is indicated for allergic conditions such as urticaria and pruritus, competing with modern non-sedating antihistamines. The drug works by blocking histamine receptor sites on effector cells, providing symptomatic relief with a 17-hour half-life enabling twice-daily dosing.
LOE Approaching2.6 years to LOE
Product is in late-stage lifecycle with 2.7 years to LOE; brand team focus likely shifting toward lifecycle management and generic preparation rather than growth initiatives.
Mechanism of Action
12.1 Mechanism of Action Carbinoxamine is an H1 receptor antagonist (antihistamine) that exhibits anticholinergic (drying) and sedative properties. Antihistamines compete with histamine for receptor sites on effector cells. 12.3 Pharmacokinetics Carbinoxamine Maleate extended-release oral…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Why This Matters for Your Career
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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.