NDAINHALATIONAEROSOL, METERED
Approved
Mar 1956
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
MEDIHALER-EPI (epinephrine bitartrate) by Pfizer is 12. Approved for regional anesthesia, analgesia for surgery, dental and 4 more indications. First approved in 1956.
Drug data last refreshed 15h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
MEDIHALER-EPI is an inhaled metered aerosol formulation of epinephrine bitartrate approved in 1956 for emergency relief of acute bronchospasm and asthma attacks. The drug works as a rapid-acting sympathomimetic that stimulates alpha and beta-adrenergic receptors to produce bronchodilation and restore airway patency. It is indicated for acute respiratory distress in patients with reactive airway disease.
LOE Approaching
This legacy product is approaching loss of exclusivity with moderate competitive pressure (score: 30/100), indicating consolidation of brand support and transition focus to retained market share defense.
Mechanism of Action
12.1 Mechanism of Action Bupivacaine blocks the generation and the conduction of nerve impulses, presumably by increasing the threshold for electrical excitation in the nerve, by slowing the propagation of the nerve impulse, and by reducing the rate of rise of the action potential. In general, the…
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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.