KARBINAL ER (carbinoxamine maleate)
Karbinal ER is indicated for adults and pediatric patients two years of age and older for the symptomatic treatment of seasonal and perennial allergic rhinitis, vasomotor rhinitis, and allergic conjunctivitis caused by inhalant allergens and foods. It is also used to treat mild, uncomplicated allergic skin manifestations of urticaria, angioedema, and dermatographism. Additionally, it serves as adjunctive therapy to epinephrine for anaphylactic reactions after acute symptoms are controlled and is indicated for the amelioration of allergic reactions to blood or plasma.
How KARBINAL ER Works
Carbinoxamine maleate is an H1 receptor antagonist that competes with histamine for H1 receptor sites on effector cells. By blocking these receptors, it inhibits the physiological effects of histamine, providing antihistaminic activity. It also exhibits significant anticholinergic (drying) and sedative properties.
Details
- Status
- Prescription
- First Approved
- 2013-03-28
- Patent Cliff
- 2029
- Routes
- ORAL
- Dosage Forms
- SUSPENSION, EXTENDED RELEASE
KARBINAL ER Approval History
What KARBINAL ER Treats
8 indicationsKARBINAL ER is approved for 8 conditions since its original approval in 2013. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Allergic Rhinitis
- Vasomotor Rhinitis
- Allergic Conjunctivitis
- Urticaria
- Angioedema
- Dermatographism
- Anaphylactic Reaction
- Allergic Reaction
KARBINAL ER Competitive Set
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MoA expansion candidates
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Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Trial Timeline
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
KARBINAL ER FDA Label Details
Indications & Usage
FDA Label (PDF)KARBINAL ER is indicated for the treatment of Allergic Rhinitis; Vasomotor Rhinitis; Allergic Conjunctivitis; Urticaria; Angioedema; Dermatographism; Anaphylactic Reaction; Allergic Reaction.
Pro Intelligence Preview
Deep insights for KARBINAL ER
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2029
- • 2 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.