TUSSIONEX PENNKINETIC
LOE ApproachingNDAORALSUSPENSION, EXTENDED RELEASE
Approved
Dec 1987
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
2/8 — Basic
TUSSIONEX PENNKINETIC by UCB Pharma is clinical pharmacology hydrocodone is a semisynthetic narcotic antitussive and analgesic with multiple actions qualitatively similar to those of codeine. First approved in 1987.
Drug data last refreshed 18h ago · AI intelligence enriched 2mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TUSSIONEX PENNKINETIC is an extended-release oral suspension combining hydrocodone (semisynthetic narcotic antitussive) and chlorpheniramine (antihistamine) for cough suppression. The Pennkinetic delivery system extends drug release via ion-exchange polymer matrix and diffusion-limiting coating, achieving peak hydrocodone levels at 3.4 hours versus 1.5 hours for immediate-release formulations. It acts directly on the cough center while the antihistamine component reduces histamine-mediated respiratory mucosal edema.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30%) signals defensive commercial strategy and smaller, maintenance-focused team.
Mechanism of Action
CLINICAL PHARMACOLOGY Hydrocodone is a semisynthetic narcotic antitussive and analgesic with multiple actions qualitatively similar to those of codeine. The precise mechanism of action of hydrocodone and other opiates is not known; however, hydrocodone is believed to act directly on the cough…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
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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.