NDASUBLINGUALSPRAY
Approved
Jan 2012
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
20
Data completeness
6/8 — Strong
SUBSYS (fentanyl) by Viatris (2) is full opioid agonists [moa]. Approved for pain, cancer pain, chronic pain and 4 more indications. First approved in 2012.
Drug data last refreshed Yesterday · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SUBSYS is a sublingual fentanyl spray approved in 2012 for management of breakthrough pain in opioid-tolerant patients and procedural sedation across multiple acute and chronic pain indications. It is a full opioid agonist that works by binding to opioid receptors in the central nervous system to produce analgesia and sedation. The sublingual route enables rapid onset of action for time-sensitive pain episodes.
$0.615MPart D
Peak4.0 years to LOEProduct is in peak lifecycle phase with modest Part D penetration; commercial team likely focused on maintenance and lifecycle extension rather than rapid growth.
Mechanism of Action
Full Opioid Agonists
Indications (7)
Worked on SUBSYS at Viatris (2)? Share your interview experience or compensation data (+7 days Pro)
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.