Who are Ketotifen Fumarate 0.035%'s main competitors?

Direct comparators (same drug class / molecular target / therapeutic area): Diphenhydramine 5%, Morphine-Promethazine, Benadryl demand, Olopatadine Nasal Spray, Azelastine - intranasal application, Fluticasone/Azelastine nasal spray.

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Last reviewed 2026-05-17 · How we verify

Ketotifen Fumarate 0.035% — Competitive Intelligence Brief

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Ketotifen Fumarate 0.035% (Ketotifen Fumarate 0.035%) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: H1-receptor antagonist and mast cell stabilizer. Area: Ophthalmology / Allergy.

phase 3 H1-receptor antagonist and mast cell stabilizer H1 histamine receptor Ophthalmology / Allergy Small molecule Live · refreshed every 30 min

Target snapshot

Ketotifen Fumarate 0.035% (Ketotifen Fumarate 0.035%) — Bausch & Lomb Incorporated. Ketotifen is a selective H1-receptor antagonist and mast cell stabilizer that prevents allergic reactions by blocking histamine release and reducing mast cell degranulation.

Comparator set (6 drugs)

Auto-detected by same drug class / molecular target / therapeutic area, ranked by phase + recency. Override with ?vs=slug1,slug2,….

Drug	Generic	Sponsor	Phase	Class	Target
Ketotifen Fumarate 0.035% TARGET	Ketotifen Fumarate 0.035%	Bausch & Lomb Incorporated	phase 3	H1-receptor antagonist and mast cell stabilizer	H1 histamine receptor
Diphenhydramine 5%	Diphenhydramine 5%	Federal State Budgetary Scientific Institution, Research Institute of Fundamental and Clinical Immunology	marketed	H1 receptor antagonist (first-generation antihistamine)	H1 histamine receptor
Morphine-Promethazine	Morphine-Promethazine	Tel-Aviv Sourasky Medical Center	marketed	Opioid analgesic combination	Mu-opioid receptor (morphine); H1 histamine receptor (promethazine)
Benadryl demand	Benadryl demand	University of Pennsylvania	marketed	First-generation H1 antihistamine	H1 histamine receptor
Olopatadine Nasal Spray	Olopatadine Nasal Spray	ORA, Inc.	marketed	Selective H1-receptor antagonist / mast cell stabilizer	H1 histamine receptor
Azelastine - intranasal application	Azelastine - intranasal application	Association Asthma, Bulgaria	marketed	Selective H1-receptor antagonist (intranasal 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

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 and mast cell stabilizer class)

Bausch & Lomb Incorporated · 1 drug in this class

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Cite this brief

Drug Landscape (2026). Ketotifen Fumarate 0.035% — Competitive Intelligence Brief. https://druglandscape.com/ci/ketotifen-fumarate-0-035. Accessed 2026-05-17.

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