NDABUCCALFILM
Approved
Jul 2009
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
3
Data completeness
4/8 — Partial
ONSOLIS (fentanyl citrate) by Hikma is analgesia. First approved in 2009.
Drug data last refreshed 1h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ONSOLIS is a buccal film formulation of fentanyl citrate, a potent opioid analgesic approved in 2009. It delivers fentanyl through the oral mucosa for rapid systemic absorption, providing analgesia in opioid-tolerant patients. The buccal route enables faster onset and avoids first-pass metabolism compared to oral administration.
LOE Approaching1.1 years to LOE
Product is approaching loss of exclusivity with limited remaining patent life; team may be consolidating or focusing on defensive strategies rather than expansion.
Mechanism of Action
analgesia.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (3)
Study to Evaluate the Efficacy and Safety of OraVescent Fentanyl Citrate Treatment for the Management of Breakthrough Pain in Opioid-Tolerant Patients With Noncancer-Related Chronic Pain
Started Aug 2006
120 enrolled
Pain
Study to Evaluate the Efficacy and Safety of ORAVESCENT Fentanyl Citrate for the Management of Breakthrough Pain
Started Sep 2005
120 enrolled
Chronic Neuropathic Pain
Study to Evaluate the Efficacy and Safety of ORAVESCENT Fentanyl Citrate for Management of Breakthrough Pain
Started Sep 2005
Chronic Low Back Pain
Why This Matters for Your Career
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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.