OXYCONTIN

Peak

oxycodone hydrochloride

NDAORALTABLET, EXTENDED RELEASEPriority Review
Approved
Apr 2010
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
3

Mechanism of Action

receptor, although it can bind to other opioid receptors at higher doses. The principal therapeutic action of oxycodone is analgesia. Like all full opioid agonists, there is no ceiling effect to analgesia for oxycodone. Clinically, dosage is titrated to provide adequate analgesia and may be limited…

Clinical Trials (3)

NCT01571362Phase 3Completed

A Research Study of an Investigational Drug ALO-02 (Oxycodone Hydrochloride and Naltrexone Hydrochloride) in Patients With Moderate to Severe Chronic Low Back Pain

Started Jun 2012
410 enrolled
Chronic PainLow Back PainAnalgesia
NCT01557257Phase 1Completed

Pharmacokinetics Study of ALO-02 and OxyContin

Started Mar 2012
13 enrolled
Management of Moderate to Severe Pain
NCT01428583Phase 3Completed

Safety Study of Oxycodone Hydrochloride and Naltrexone Hydrochloride Extended-Release Capsules in Subjects With Moderate to Severe Chronic Noncancer Pain

Started Dec 2010
395 enrolled
Chronic Noncancer Pain

Loss of Exclusivity

LOE Date
Mar 29, 2030
49 months away
Patent Expiry
Mar 29, 2030

Patent Records (5)

Patent #ExpiryTypeUse Code
9775808
Aug 24, 2027
Product
11304909
Aug 24, 2027
U-1556
11964056
Aug 24, 2027
Product
12246094
Aug 24, 2027
Product
12280152
Aug 24, 2027
Product