NUCYNTA ER
Peaktapentadol hydrochloride
NDAORALTABLET, EXTENDED RELEASE
Approved
Aug 2011
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
2
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…
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
Loss of Exclusivity
LOE Date
Mar 22, 2029
37 months away
Patent Expiry
Mar 22, 2029
Patent Records (4)
| Patent # | Expiry | Type | Use Code |
|---|---|---|---|
| 11344512 | Apr 21, 2028 | U-3391 | |
| 8536130 | Sep 22, 2028 | U-1276 | |
| 11344512*PED | Oct 21, 2028 | — | |
| 8536130*PED | Mar 22, 2029 | — |