TUZISTRA XR
LOE Approachingchlorpheniramine polistirex; codeine polistirex
NDAORALSUSPENSION, EXTENDED RELEASE
Approved
Apr 2015
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Data completeness
3/8 — Basic
TUZISTRA XR (chlorpheniramine polistirex; codeine polistirex) is mu-opioid receptor, although it can interact with other opioid receptors at higher doses. First approved in 2015.
Drug data last refreshed 20h ago · AI intelligence enriched 2mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TUZISTRA XR is an extended-release oral suspension combining chlorpheniramine polistirex (H1-receptor antagonist) and codeine polistirex (mu-opioid agonist) for cough suppression. It acts centrally on the cough center via opioid mechanisms while reducing histamine-mediated airway edema through antihistamine and anticholinergic properties. The polistirex formulation enables extended-release delivery for once-daily dosing.
Peak2.7 years to LOE
Product is at peak lifecycle stage with moderate competitive pressure (score: 8/10); commercial teams should anticipate defensive strategy and possible workforce optimization pre-LOE.
Mechanism of Action
mu-opioid receptor, although it can interact with other opioid receptors at higher doses. The precise mechanism of action of hydrocodone and other opiates is not known; however, hydrocodone is believed to act centrally on the cough center. In excessive doses, hydrocodone will depress respiration.…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Why This Matters for Your Career
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.