NDAORALSOLUTION
Approved
Oct 2012
Lifecycle
LOE Approaching
Competitive Pressure
35/100
Clinical Trials
3
Data completeness
3/8 — Basic
NUCYNTA (tapentadol hydrochloride) by Humanwell Pharmaceutical is centrally-acting synthetic analgesic. First approved in 2012.
Drug data last refreshed 1h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
NUCYNTA is an oral synthetic analgesic combining mu-opioid receptor agonism with norepinephrine reuptake inhibition for centrally-acting pain relief. The dual mechanism derives analgesia from both opioid and noradrenergic pathways, though the clinical significance of this combination remains incompletely characterized. It is indicated for moderate to severe pain management in adult patients.
LOE Approaching0mo to LOE
Product approaching loss of exclusivity (July 2026) with moderate competitive pressure (35/100), signaling transition from growth team to generic defense and lifecycle management roles.
Mechanism of Action
centrally-acting synthetic analgesic. The exact mechanism of action is unknown. Although the clinical relevance is unclear, preclinical studies have shown that tapentadol is a mu-opioid receptor (MOR) agonist and a norepinephrine reuptake inhibitor (NRI). Analgesia in animal models is derived from…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (3)
A Safety and Effectiveness Study of Prolonged Release Tapentadol Hydrochloride Among Filipino Patients With Moderate to Severe Chronic Non-Cancer Pain
Started Oct 2014
0Moderate to Severe Chronic Non-cancer Pain
A Safety and Effectiveness Study of Immediate Release Tapentadol Hydrochloride Among Filipino Patients With Moderate to Severe Acute Non-Cancer Pain
Started Oct 2014
0Moderate to Severe Acute Non-Cancer Pain
NUCYNTA (Tapentadol Immediate Release) Versus Oxycodone Immediate Release in the Treatment of Acute Low Back Pain
Started Sep 2009
667 enrolled
PainBack PainLow Back Pain+1 more
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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.