NDAORALTABLET, EXTENDED RELEASE
Approved
Aug 2011
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
2
Data completeness
5/8 — Partial
NUCYNTA ER (tapentadol hydrochloride) by Humanwell Pharmaceutical is centrally-acting synthetic analgesic. First approved in 2011.
Drug data last refreshed 2h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
NUCYNTA ER is an extended-release oral tablet containing tapentadol hydrochloride, a centrally-acting synthetic analgesic approved in 2011. It works through dual mechanisms: mu-opioid receptor agonism and norepinephrine reuptake inhibition, though the exact clinical relevance of each mechanism remains unclear. The drug is indicated for chronic pain management in patients requiring continuous opioid therapy.
$53MPart D
LOE Approaching2.5 years to LOEProduct is in late-stage lifecycle with 2.5 years to loss of exclusivity; expect consolidation of brand team and focus on generic transition strategy.
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 (2)
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
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.