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 6h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
MEDIHALER-EPI is an inhalation aerosol formulation of epinephrine bitartrate, a sympathomimetic agent used as an emergency treatment for acute bronchospasm and anaphylaxis. The drug works by stimulating alpha and beta-adrenergic receptors, rapidly reversing airway constriction and cardiovascular collapse. It has been a standard emergency therapeutic for over 65 years.
LOE Approaching
This legacy product is approaching loss of exclusivity with 30% competitive pressure, indicating a contracting team and focus on cost management rather than growth initiatives.
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.