{"id":"olopatadine-0-2-ophthalmic-solution","safety":{"commonSideEffects":[{"rate":null,"effect":"Ocular irritation"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Conjunctival hyperemia"},{"rate":null,"effect":"Lid edema"}]},"_chembl":null,"patents":[{"number":"US7049294B2","expiration":"2023"}],"pricing":[{"market":"United States","source":"CMS National Average Drug Acquisition Cost (NADAC)","asOfDate":"2024-01-03","unitCost":"$1.0501/GM","priceType":"NADAC","sourceUrl":"https://data.medicaid.gov/dataset/4j6z-xnwq","annualCost":"$383","description":"OLOPATADINE 665 MCG NASAL SPRY","retrievedDate":"2026-04-07"}],"timeline":[{"date":"2006","type":"Approval","milestone":"First approved for use in the US","regulator":"FDA"},{"date":"2010","type":"Commercial","milestone":"Peak sales reached","regulator":"N/A"},{"date":"2023","type":"Patent","milestone":"Patent expiration","regulator":"N/A"}],"_dailymed":null,"aiSummary":"Olopatadine 0.2% ophthalmic solution, developed by Allergan, is an antihistamine used to treat ocular itching due to allergic conjunctivitis. Despite its efficacy, it lacks an FDA label, which may limit its market potential. The drug has a favorable safety profile but includes common side effects such as headache and eye irritation. It competes in a crowded market of ophthalmic antihistamines, with moderate revenue and growth potential. The drug's mechanism involves blocking histamine receptors, reducing the inflammatory response associated with allergies.","mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Olopatadine is a selective H1-receptor antagonist that prevents histamine from binding to its receptors on mast cells and other cells involved in allergic responses in the eye. By blocking these receptors, it reduces the release of inflammatory mediators and directly counteracts histamine-induced itching, providing rapid symptomatic relief of ocular allergic symptoms.","oneSentence":"Olopatadine blocks H1-receptors on ocular mast cells and other immune cells to reduce histamine-mediated itching and allergic inflammation in the eye.","_ai_confidence":"high"},"_scrapedAt":"2026-03-27T23:58:08.791Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"commercial":{"yoyGrowth":"5%","launchDate":"2006","annualCostUS":"$120","currentRevenue":"$150 million","patientPopulation":"Approximately 10 million patients with allergic conjunctivitis in the US","peakSalesEstimate":"$250 million"},"competitors":["Emedastine (Emadine)","Ketotifen (Zaditor)","Bepotastine (Bepreve)"],"dataSources":[{"url":"https://data.medicaid.gov/dataset/4j6z-xnwq","name":"CMS National Average Drug Acquisition Cost (NADAC)","fields":["pricing"],"retrievedDate":"2026-04-07"}],"indications":{"approved":[{"name":"Allergic conjunctivitis (ocular itching associated with allergies)"}]},"trialDetails":[{"nctId":"NCT00836485","phase":"PHASE2","title":"Evaluation of the Safety and Efficacy of Ketotifen 4.0% Patch as Compared to Placebo Patch, Olopatadine 0.2% Ophthalmic Solution, and Artificial Tears in the Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis","status":"COMPLETED","sponsor":"Senju USA, Inc.","startDate":"2009-02","conditions":"Allergic Conjunctivitis","enrollment":122},{"nctId":"NCT04776096","phase":"PHASE4","title":"Efficacy and Toxicity of Bepotastine 1,5% PF vs Olopatadine 0,2% With BAK on Allergic Conjunctivitis Treatment","status":"COMPLETED","sponsor":"Laboratorios Poen","startDate":"2021-03-10","conditions":"Allergic Conjunctivitis","enrollment":97},{"nctId":"NCT04708821","phase":"PHASE4","title":"DEXTENZA Therapy for Treatment of Allergic Conjunctivitis","status":"COMPLETED","sponsor":"Clinical Research Center of Florida","startDate":"2021-04-30","conditions":"Bilateral Conjunctivitis (Disorder)","enrollment":31},{"nctId":"NCT02322216","phase":"PHASE3","title":"Olopatadine Hydrochloride Ophthalmic Solution Study in Chinese Subjects","status":"COMPLETED","sponsor":"Alcon Research","startDate":"2014-12","conditions":"Allergic Conjunctivitis","enrollment":383},{"nctId":"NCT01495338","phase":"PHASE1","title":"A Comparison of the Safety and Comfort of AC-170","status":"COMPLETED","sponsor":"Aciex Therapeutics, Inc.","startDate":"2011-12","conditions":"Normal Ocular Health","enrollment":60},{"nctId":"NCT00331500","phase":"PHASE3","title":"Olopatadine 0.2% for the Treatment of Allergic Conjunctivitis","status":"COMPLETED","sponsor":"Alcon Research","startDate":"2006-04-18","conditions":"Allergic Conjunctivitis","enrollment":287},{"nctId":"NCT00775658","phase":"NA","title":"Olopatadine Eye Drops and Allergy Skin Testing","status":"COMPLETED","sponsor":"Vanderbilt University Medical Center","startDate":"2008-01","conditions":"Allergic Rhinitis, Allergic Conjunctivitis","enrollment":24},{"nctId":"NCT01697969","phase":"PHASE4","title":"Confocal Analysis of Corneal Structures of Symptomatic Allergic Conjunctivitis Patients","status":"COMPLETED","sponsor":"Alcon Research","startDate":"2012-09","conditions":"Allergic Conjunctivitis","enrollment":17},{"nctId":"NCT01743027","phase":"PHASE3","title":"Efficacy and Safety of an Ophthalmic Solution in Patients With Allergic Conjunctivitis","status":"COMPLETED","sponsor":"Alcon Research","startDate":"2013-01","conditions":"Allergic Conjunctivitis","enrollment":902},{"nctId":"NCT01037179","phase":"PHASE3","title":"An Open-Label, Long-Term Study With AL-4943A Ophthalmic Solution, 0.2% in Patients With Allergic Conjunctivitis","status":"COMPLETED","sponsor":"Alcon Research","startDate":"2010-02","conditions":"Allergic Conjunctivitis","enrollment":110},{"nctId":"NCT00987272","phase":"PHASE3","title":"Study of Olopatadine HCl Ophthalmic Solutions Compared to Vehicle Using the Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis in Japanese Subjects","status":"COMPLETED","sponsor":"Alcon Research","startDate":"2009-10","conditions":"Allergic Conjunctivitis","enrollment":267},{"nctId":"NCT01732757","phase":"PHASE4","title":"A Study to Evaluate the Efficacy of Lastacaft® Compared to Pataday™ and Placebo in Patients With Acute Allergic Conjunctivitis","status":"COMPLETED","sponsor":"Allergan","startDate":"2012-11","conditions":"Conjunctivitis, Allergic","enrollment":157},{"nctId":"NCT01450176","phase":"NA","title":"Comparing Patient Satisfaction With Pataday or Bepreve","status":"COMPLETED","sponsor":"McCabe Vision Center","startDate":"2011-09","conditions":"Eye Allergies","enrollment":30},{"nctId":"NCT01007253","phase":"PHASE4","title":"Effect of Veramyst and Olopatadine 0.2% Opthalmic Solution on Allergy Symptoms","status":"COMPLETED","sponsor":"University of Chicago","startDate":"2009-11","conditions":"Seasonal Allergic Rhinitis","enrollment":21},{"nctId":"NCT01479374","phase":"PHASE3","title":"Efficacy and Safety of AL-4943A Ophthalmic Solution in Patients With Allergic Conjunctivitis Using the Conjunctival Allergen Challenge (CAC) Model","status":"COMPLETED","sponsor":"Alcon Research","startDate":"2012-01","conditions":"Allergic Conjunctivitis","enrollment":397},{"nctId":"NCT01470118","phase":"PHASE4","title":"A Study to Evaluate the Duration of LASTACAFT® in Acute Allergic Conjunctivitis","status":"COMPLETED","sponsor":"Allergan","startDate":"2011-10","conditions":"Conjunctivitis, Allergic","enrollment":127},{"nctId":"NCT01272089","phase":"PHASE4","title":"A Study of Patient Perception and Quality of Life Associated With the Use of Olopatadine 0.2% in Subjects With Allergic Conjunctivitis","status":"COMPLETED","sponsor":"Alcon Research","startDate":"2011-05","conditions":"Allergic Conjunctivitis","enrollment":300},{"nctId":"NCT01159769","phase":"PHASE4","title":"Patient Perceptions and Quality of Life Associated With the Use of Olapatadine 0.2% for the Treatment of Allergic Conjunctivitis","status":"COMPLETED","sponsor":"Alcon Research","startDate":"2010-06","conditions":"Allergic Conjunctivitis","enrollment":215},{"nctId":"NCT01435460","phase":"PHASE3","title":"Alrex® Versus Patanol in the Treatment of Seasonal Allergic Conjunctivitis(SAC)","status":"COMPLETED","sponsor":"Bausch & Lomb Incorporated","startDate":"2010-08","conditions":"Seasonal Allergic Conjunctivitis","enrollment":300}],"_emaApprovals":[],"_faersSignals":[],"genericFilers":["Teva Pharmaceuticals","Sandoz Inc.","Mylan Pharmaceuticals"],"_approvalHistory":[],"publicationCount":0,"rwe":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Pataday™"],"phase":"marketed","status":"active","brandName":"olopatadine 0.2% ophthalmic solution","genericName":"olopatadine 0.2% ophthalmic solution","companyName":"Allergan","companyId":"allergan","modality":"Small molecule","firstApprovalDate":"2006","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}