NDAORALTABLET, EXTENDED RELEASE
Approved
Jan 2017
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
20
Data completeness
3/8 — Basic
Drug data last refreshed 6m ago · AI intelligence enriched 3d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
VANTRELA ER is an extended-release oral tablet formulation of hydrocodone bitartrate, an opioid analgesic indicated for chronic pain management. It delivers hydrocodone over an extended period to reduce dosing frequency while maintaining therapeutic coverage. The drug acts as a mu-opioid receptor agonist to reduce pain perception.
LOE Approaching2.9 years to LOE
As LOE approaches by mid-2029, the commercial team is likely consolidating focus on high-value accounts and maximizing remaining exclusivity period before generic entry.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Safety, Pharmacokinetics (PK), and Effectiveness of Hydrocodone Bitartrate (HYD) Extended-Release Tablets in Children
Started Jan 2017
0Pain
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
Abuse Potential of Intranasal VYCAVERT Tablets (Hydrocodone Bitartrate/Acetaminophen) in Recreational Opioid Users
Started Feb 2013
44 enrolled
Opioid-Related Disorders
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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.