Diphenhydramine 5% — Competitive Intelligence Brief

Diphenhydramine 5% (Diphenhydramine 5%) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: H1 receptor antagonist (first-generation antihistamine). Area: Allergy/Immunology.

marketed H1 receptor antagonist (first-generation antihistamine) H1 histamine receptor Allergy/Immunology Small molecule

Target snapshot

Diphenhydramine 5% (Diphenhydramine 5%) — Federal State Budgetary Scientific Institution, Research Institute of Fundamental and Clinical Immunology. Diphenhydramine is a first-generation antihistamine that blocks H1 histamine receptors to reduce allergic and inflammatory responses.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Diphenhydramine 5% TARGET	Diphenhydramine 5%	Federal State Budgetary Scientific Institution, Research Institute of Fundamental and Clinical Immunology	marketed	H1 receptor antagonist (first-generation antihistamine)	H1 histamine receptor
Fluticasone/Azelastine nasal spray	Fluticasone/Azelastine nasal spray	University of Chicago	marketed	Intranasal corticosteroid/antihistamine combination	Glucocorticoid receptor; H1 histamine receptor
olopatadine (OLO)	olopatadine (OLO)	University of Chicago	marketed	Selective H1-receptor antagonist / mast cell stabilizer	H1 histamine receptor
Ciclesonide & Levocetirizine	Ciclesonide & Levocetirizine	Handok Inc.	marketed	Inhaled corticosteroid + selective H1-receptor antagonist combination	Glucocorticoid receptor (ciclesonide); H1 histamine receptor (levocetirizine)
diphenhydramine/phenylephrine/cocoa; placebo; dextromethorphan	diphenhydramine/phenylephrine/cocoa; placebo; dextromethorphan	Montefiore Medical Center	marketed	Combination cold/cough/allergy remedy	H1 histamine receptor (diphenhydramine); alpha-1 adrenergic receptor (phenylephrine); NMDA receptor and sigma-1 receptor (dextromethorphan)
Antihistamine Cetirizine Hydrochloride	Antihistamine Cetirizine Hydrochloride	Goldman, Butterwick, Fitzpatrick and Groff	marketed	H1-receptor antagonist (second-generation antihistamine)	H1 histamine receptor
Benadryl demand	Benadryl demand	University of Pennsylvania	marketed	First-generation H1 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 (H1 receptor antagonist (first-generation antihistamine) class)

1. Federal State Budgetary Scientific Institution, Research Institute of Fundamental and Clinical Immunology · 1 drug in this class
2. Organon and Co · 1 drug in this class
3. Sanofi · 1 drug in this class