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Hydroxyzine HCL — Competitive Intelligence Brief

Hydroxyzine HCL (Hydroxyzine HCL) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: First-generation H1 antihistamine. Area: Psychiatry, Dermatology, Allergy/Immunology.

marketed First-generation H1 antihistamine H1 histamine receptor Psychiatry, Dermatology, Allergy/Immunology Small molecule Live · refreshed every 30 min

Target snapshot

Hydroxyzine HCL (Hydroxyzine HCL) — National Cancer Institute (NCI). Hydroxyzine is a first-generation antihistamine that blocks H1 receptors to reduce histamine-mediated allergic and anxiety responses.

Comparator set (6 drugs)

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DrugGenericSponsorPhaseClassTargetApproval / PDUFA
Hydroxyzine HCL TARGET Hydroxyzine HCL National Cancer Institute (NCI) marketed First-generation H1 antihistamine H1 histamine receptor
Antihistamine Cetirizine Hydrochloride Antihistamine Cetirizine Hydrochloride Goldman, Butterwick, Fitzpatrick and Groff marketed H1-receptor antagonist (second-generation antihistamine) H1 histamine receptor
montelukast and cetirizine montelukast and cetirizine Medical University of Lodz marketed Leukotriene receptor antagonist and H1-receptor antagonist combination CysLT1 receptor (montelukast); H1 histamine receptor (cetirizine)
Morphine-Promethazine Morphine-Promethazine Tel-Aviv Sourasky Medical Center marketed Opioid analgesic combination Mu-opioid receptor (morphine); H1 histamine receptor (promethazine)
Fluticasone/Azelastine nasal spray Fluticasone/Azelastine nasal spray University of Chicago marketed Intranasal corticosteroid/antihistamine combination Glucocorticoid receptor; H1 histamine receptor
Ciclesonide & Levocetirizine Ciclesonide & Levocetirizine Handok Inc. marketed Inhaled corticosteroid + selective H1-receptor antagonist combination Glucocorticoid receptor (ciclesonide); H1 histamine receptor (levocetirizine)
fexofenadine HCl fexofenadine HCl Sanofi marketed Second-generation H1-receptor antagonist (non-sedating antihistamine) H1 histamine receptor

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (First-generation H1 antihistamine class)

  1. National Cancer Institute (NCI) · 1 drug in this class
  2. University Hospital, Toulouse · 1 drug in this class
  3. University of Pennsylvania · 1 drug in this class

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Cite this brief

Drug Landscape (2026). Hydroxyzine HCL — Competitive Intelligence Brief. https://druglandscape.com/ci/hydroxyzine-hcl. Accessed 2026-05-13.

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