ZOHYDRO ER
Peakhydrocodone bitartrate
NDAORALCAPSULE, EXTENDED RELEASE
Approved
Oct 2013
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
15
Clinical Trials (5)
Study to Evaluate the Analgesic Efficacy and Safety of Hydrocodone Bitartrate/Acetaminophen Immediate-Release Tablets in Participants With Moderate to Severe Pain Following Bunionectomy
Started Aug 2015
569 enrolled
Pain
Open-Label, Extension Study to Evaluate the Safety of Hydrocodone Bitartrate Extended-Release Tablets
Started Jul 2013
182 enrolled
Low Back Pain
Efficacy and Safety of Hydrocodone Bitartrate Extended-Release Tablets for Moderate to Severe Chronic Low Back Pain
Started Mar 2013
625 enrolled
Low Back Pain
A Crossover Study to Assess the Bioequivalence of Hydrocodone Bitartrate Extended-Release Tablet
Started Jan 2013
54 enrolled
Pain
A Crossover Study to Assess the Bioequivalence of Hydrocodone Bitartrate Extended-Release Tablet
Started Dec 2012
54 enrolled
Pain
Loss of Exclusivity
LOE Date
Sep 12, 2034
103 months away
Patent Expiry
Sep 12, 2034
External Resources