XTAMPZA ER

Peak

oxycodone

NDAORALCAPSULE, EXTENDED RELEASE
Approved
Apr 2016
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20

Mechanism of Action

Full Opioid Agonists

Pharmacologic Class:

Opioid Agonist

Clinical Trials (5)

NCT01825447Phase 1Completed

A Study to Characterize the Abuse Liability of Intravenous Oxycodone Alone or in Combination With Intravenous Naltrexone in Healthy, Non-Dependent, Recreational Opioid Users

Started Jul 2013
89 enrolled
Healthy
NCT01740414Phase 2Completed

Effects of Ibudilast on Oxycodone Self-administration in Opioid Abusers

Started Nov 2012
28 enrolled
Opioid AbuseOpioid Dependence
NCT01677039Phase 1Completed

Study to Determine the Effects of Co-Administration of Alcohol on the Absorption of Oxycodone From a Proprietary Controlled-Release Formulation

Started Sep 2012
19 enrolled
Healthy
NCT01677065N/ACompleted

A Randomized, Two-way, Crossover Study to Estimate the Relative Bioavailability of a Controlled-release Formulation of Oxycodone (40 mg) With Sequestered Naltrexone Compared With Immediate-release Oxycodone Tablets (20 mg) in Healthy Volunteers

Started Sep 2012
14 enrolled
Healthy
NCT01631513Phase 4Withdrawn

An Open-label Evaluation of Tapentadol Extended Release (ER) in Participants With Moderate to Severe Chronic Pain After Conversion From Hydrocodone, Oxycodone Controlled Release (CR), and/or Morphine Sustained Release (SR)

Started Aug 2012
0
PainChronic Back PainChronic Low Back Pain+1 more

Loss of Exclusivity

LOE Date
Sep 2, 2036
127 months away
Patent Expiry
Sep 2, 2036

Patent Records (5)

Patent #ExpiryTypeUse Code
7771707
Oct 9, 2028
Product
10004729
Dec 10, 2030
Product
U-1556
10668060
Dec 10, 2030
Product
U-1556
9682075
Dec 10, 2030
Product
U-1556
10188644
Sep 2, 2036
Product
U-1556