NDAINHALATIONAEROSOL, METERED
Approved
Mar 1956
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
4/8 — Partial
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 17h ago · AI intelligence enriched 3d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
MEDIHALER-EPI is an inhaled metered aerosol containing epinephrine bitartrate, a sympathomimetic agent that stimulates alpha and beta-adrenergic receptors. It is indicated for emergency relief of bronchospasm and acute asthma symptoms through rapid systemic absorption via the respiratory tract. The drug acts as a potent vasoconstrictor and bronchodilator, restoring airway patency during acute respiratory distress.
LOE Approaching
Product approaching loss of exclusivity with 30% competitive pressure; brand team likely focused on lifecycle management and defensive positioning rather than growth expansion.
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.