NDAINJECTIONINJECTABLE
Approved
May 2008
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
2/8 — Basic
ORAVERSE (phentolamine mesylate) by Septodont is soft-tissue anesthesia and the associated functional deficits is not fully understood. First approved in 2008.
Drug data last refreshed 13h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ORAVERSE (phentolamine mesylate) is an injectable alpha-adrenergic antagonist that reverses soft-tissue anesthesia and associated functional deficits by blocking vasoconstriction caused by epinephrine in local anesthetics. It is used in dental and oral surgical settings to accelerate recovery of sensation and motor function after lidocaine-epinephrine anesthesia. The drug increases local blood flow through vasodilatation, enabling faster clearance of anesthetic from the injection site.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30); team likely in transition mode with smaller commercial footprint than growth-stage products.
Mechanism of Action
soft-tissue anesthesia and the associated functional deficits is not fully understood. Phentolamine mesylate, the active ingredient in OraVerse, produces an alpha-adrenergic block of relatively short duration resulting in vasodilatation when applied to vascular smooth muscle. In an animal model,…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Career Relevance
ORAVERSE offers limited career growth opportunities due to its niche specialty market and approaching LOE; positions are primarily in commercial and market access functions focused on defending market share and optimizing reimbursement. Career progression on this product requires rapid transition planning before generic competition intensifies.
Brand Manager
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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.