NDAORALSOLUTION
Approved
Jan 2008
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
7
Data completeness
4/8 — Partial
XYZAL (levocetirizine dihydrochloride) by Sanofi is levocetirizine, the active enantiomer of cetirizine, is an antihistamine; its principal effects are mediated via selective inhibition of h 1 receptors. Approved for allergic rhinitis, urticaria. First approved in 2008.
Drug data last refreshed 21h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
XYZAL (levocetirizine dihydrochloride) is a selective H1-receptor antagonist antihistamine approved for allergic rhinitis and urticaria. It is the active enantiomer of cetirizine with 2-fold higher H1-receptor affinity than its parent compound. Administered as an oral solution, it provides symptomatic relief from allergic conditions.
LOE Approaching
Product approaching loss of exclusivity signals potential downsizing of commercial team and shift toward generic transition planning.
Mechanism of Action
Levocetirizine, the active enantiomer of cetirizine, is an antihistamine; its principal effects are mediated via selective inhibition of H 1 receptors. The antihistaminic activity of levocetirizine has been documented in a variety of animal and human models. In vitro binding studies revealed that…
Indications (2)
Worked on XYZAL at Sanofi? Share your interview experience or compensation data (+7 days Pro)
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.