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 6d 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 treatment of acute bronchospasm and anaphylaxis. The drug works as a non-selective adrenergic agonist that rapidly increases heart rate, blood pressure, and bronchial airway diameter by stimulating alpha and beta-adrenergic receptors. It is a rescue therapy for acute respiratory distress and anaphylactic reactions requiring rapid systemic absorption.
LOE Approaching
With lifecycle status approaching loss of exclusivity and no active patent protections, brand teams should expect significant margin compression and consolidation of commercial support infrastructure.
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.