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CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride is a marketed antihistamine primarily indicated for the relief of hay fever symptoms. The drug maintains a strong market position with a key composition patent expiring in 2028, providing a significant period of exclusivity. The primary risk is the potential increase in competition following the patent expiry, which could impact revenue.
At a glance
| Generic name | CETIRIZINE HYDROCHLORIDE |
|---|---|
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 1995 |
Approved indications
- Hay Fever Symptoms Relief
- Upper Respiratory Allergies Symptoms Relief
Common side effects
Key clinical trials
- IMPOWER-QoL: IMPact Of Discontinuing Premedication for WEekly Paclitaxel on bReast Cancer Patient's Quality Of Life (NA)
- Alternate Pre-med in Anti-Cluster of Differentiation 20 (CD20) Pilot Project (PHASE3)
- An Open-Label, Single-Arm, Dose-Escalation Phase I Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of EDB-102 in Patients With EGFR L858R-Mutant, Third-Generation TKI-Resistant Advanced Non-Small Cell Lung Cancer With Liver Metastases (PHASE1)
- Rash & Diarrhea Prophylaxis With Capivasertib (PHASE2)
- Alpelisib/iNOS Inhibitor/Nab-paclitaxel in Patients With HER2 Negative Metaplastic Breast Cancer (MpBC) (PHASE2)
- A Multi-dose Study of ARC-520 in Patients With Hepatitis B 'e' Antigen (HBeAg) Negative, Chronic Hepatitis B Virus (HBV) Infection (PHASE2)
- Extension Study of the Safety and Efficacy of Multi-dose Intravenous ARC-520 in Patients With Chronic Hepatitis B (HBV) Infection (PHASE2)
- Study of ARC-520 With or Without Other Drugs Used in the Treatment of Chronic Chronic Hepatitis B Virus (HBV) (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- CETIRIZINE HYDROCHLORIDE CI brief — competitive landscape report
- CETIRIZINE HYDROCHLORIDE updates RSS · CI watch RSS