{"answer":{"query":"Restasis","resolved_as":"applications","packages":11,"applications":["NDA050790"],"identity":{"application_numbers":["NDA050790"],"marketing_categories":["NDA","NDA AUTHORIZED GENERIC"],"labelers":[],"dosage_forms":[{"text":"EMULSION","untrusted":true}],"marketing_start":{"earliest":"2003-04-01","latest":"2022-05-11","packages_with_a_start_date":11}},"generic_entry":[{"application":"NDA050790","date":"2034-05-11","reading":"upper bound from listed dates, not a forecast","basis":"latest of all listed patent and exclusivity expiries in this Orange Book edition; an upper bound from listed dates only, not a forecast of launch (litigation, settlements, delisting, tentative approvals and 180-day status are not modelled)","driver":{"kind":"patent","ref":"9669974","productNo":"002"},"latest_patent_expiry":"2034-05-11","latest_exclusivity_expiry":"NOT_PROVIDED","dated_barriers":4,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":4,"exclusivities_listed":0,"fact_id":"a514f2bca7c3dff6f73e6730"}],"label_history":{"events_total":14,"non_cmc_events":6,"counts_by_class":{"LABELING":6},"cmc_events":8,"recent_non_cmc_events":[{"application":"NDA050790","submission_no":31,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-08-21","documents":[{"type":"Letter","date":"2025-08-22","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/050790Orig1s031ltr.pdf","untrusted":true}},{"type":"Label","date":"2025-08-26","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/050790s031lbl.pdf","untrusted":true}}],"fact_id":"3b9992ee76174eedfcb44021"},{"application":"NDA050790","submission_no":27,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2017-07-18","documents":[{"type":"Label","date":"2017-07-19","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/050790s027lbl.pdf","untrusted":true}},{"type":"Letter","date":"2017-07-21","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/050790Orig1s027ltr.pdf","untrusted":true}}],"fact_id":"ab0da439926bca14c33801e5"},{"application":"NDA050790","submission_no":25,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2016-10-27","documents":[{"type":"Label","date":"2016-12-09","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050790s024s025lbl.pdf","untrusted":true}}],"fact_id":"a15dd37bb65a15cd704f33a6"},{"application":"NDA050790","submission_no":20,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2012-12-03","documents":[{"type":"Letter","date":"2012-12-05","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050790Orig1s020ltr.pdf","untrusted":true}},{"type":"Label","date":"2012-12-04","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050790s020lbl.pdf","untrusted":true}}],"fact_id":"ad3f45ee9c64dc9b6342ef7b"},{"application":"NDA050790","submission_no":4,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2003-10-01","documents":[{"type":"Letter","date":"2003-10-01","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50790scp003slr004ltr,.pdf","untrusted":true}}],"fact_id":"9642f914f00db6a8e6adc706"}],"note":"a dated list of FDA supplements and their classes, not a reading of what changed in the label"},"substitution":{"products_total":2,"te_code_counts":{"AB":1,"NOT_PROVIDED":1},"marketing_status_counts":{"Prescription":2},"meaning":"raw FDA codes; the therapeutic equivalence code says whether FDA rates a generic as substitutable, and what that means for a given prescription is for a pharmacist or prescriber","products":[{"application":"NDA050790","product_no":"001","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"RESTASIS","untrusted":true},"form":{"text":"EMULSION;OPHTHALMIC","untrusted":true},"strength":{"text":"0.05%","untrusted":true}},{"application":"NDA050790","product_no":"002","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"RESTASIS MULTIDOSE","untrusted":true},"form":{"text":"EMULSION;OPHTHALMIC","untrusted":true},"strength":{"text":"0.05%","untrusted":true}}]},"spending":{"reported_under":{"generic":{"text":"Cyclosporine","untrusted":true},"brand":{"text":"Restasis","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":1451534384,"claims":1610398,"beneficiaries":538644,"average_spending_per_claim_usd":901.35133304,"fact_id":"309691c55072af3905536245"},{"year":2021,"gross_spending_usd":1628418855.6,"claims":1684621,"beneficiaries":581082,"average_spending_per_claim_usd":966.63810769,"fact_id":"ee1ef3368a0b6a64b17fbe30"},{"year":2022,"gross_spending_usd":1646136456.9,"claims":1593932,"beneficiaries":556562,"average_spending_per_claim_usd":1032.7519975,"fact_id":"2dc7d263599c36cc35443673"},{"year":2023,"gross_spending_usd":1501664198.2,"claims":1431080,"beneficiaries":492479,"average_spending_per_claim_usd":1049.3223287,"fact_id":"1d0fdd9ba27a2547a11c941f"},{"year":2024,"gross_spending_usd":1289753141.8,"claims":1360998,"beneficiaries":472657,"average_spending_per_claim_usd":947.65248871,"fact_id":"4c91319c74dd58386a71ac98"}],"rebate_caveat":"CMS's dataset states spending is gross drug cost and does not reflect manufacturers' rebates or other price concessions.","not_a_patient_price":"Spending is the total paid by Medicare, plans and beneficiaries for the drug's claims, not what a patient pays.","meaning":"a drug-level aggregate of Medicare Part D claims for all manufacturers combined; not a formulary, not coverage","source":{"dataset":{"text":"data-year-2024, modified 2026-06-25","untrusted":true},"link":{"text":"https://data.cms.gov/summary-statistics-on-use-and-payments/medicare-medicaid-spending-by-drug/medicare-part-d-spending-by-drug","untrusted":true}}},"orphan_designation":{"ingredients":[{"ingredient":{"text":"Cyclosporine; cyclosporine","untrusted":true},"designation_count":5,"approved_count":1,"recent":[{"designated":"2009-02-17","use":{"text":"Prophylaxis of graft-versus-host disease","untrusted":true},"status":"Designated/Designation Withdrawn or Revoked","sponsor":{"text":"Sigmoid Pharma Limited","untrusted":true},"approved":false},{"designated":"2009-02-17","use":{"text":"Treatment of graft-versus-host disease","untrusted":true},"status":"Designated/Designation Withdrawn or Revoked","sponsor":{"text":"Sigmoid Pharma Limited","untrusted":true},"approved":false},{"designated":"2007-05-04","use":{"text":"Treatment of vernal keratoconjunctivitis","untrusted":true},"status":"Designated/Approved","sponsor":{"text":"Harrow Eye, LLC","untrusted":true},"approved":true},{"designated":"2003-11-25","use":{"text":"Prophylaxis of organ rejection in patients receiving allogeneic lung transplant","untrusted":true},"status":"Designated","sponsor":{"text":"APT Pharmaceuticals, Inc.","untrusted":true},"approved":false},{"designated":"2003-11-25","use":{"text":"Treatment of acute rejection in patients requiring allogenic lung transplants","untrusted":true},"status":"Designated","sponsor":{"text":"APT Pharmaceuticals, Inc.","untrusted":true},"approved":false}],"read_on":"2026-11-07T12:00:00.000Z","fact_id":"fe3b5477510f10718514590b"}],"reading":"a designation is not an approval and not a statement that the drug treats the condition; 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See the provenance tool for each fact's licence label."},"unknown":[{"code":"NO_DATA","field":"price","reason":"no NADAC price, negotiated price or federal upper limit for these packages"},{"code":"NO_DATA","field":"recalls","reason":"no FDA enforcement report naming a package of these applications is recorded"},{"code":"NO_DATA","field":"supply","reason":"no FDA shortage row and no termination date for these packages"},{"code":"NO_DATA","field":"trials","reason":"no ClinicalTrials.gov record set for this drug's ingredient is in the edition"},{"code":"NO_DATA","field":"assistance_and_offers","reason":"no assistance program lists this drug and no manufacturer offer naming it is recorded; that does not mean none exists"},{"code":"NO_DATA","field":"policy","reason":"no Federal Register event in the edition names this drug or its programs"},{"code":"AMBIGUOUS","field":"spending","reason":"2 brand and generic name pairs match; the series shown is the one with the newest year and the largest spending"},{"code":"NO_DATA","field":"biologic_status","reason":"no biologic application of this drug has a Purple Book status in the edition (a drug that is not a biologic has none)"},{"code":"NO_DATA","field":"payment_limit","reason":"no HCPCS code whose NDC crosswalk names a package of these applications has a Part B payment limit in the edition"},{"code":"NO_DATA","field":"rems","reason":"no REMS@FDA program is tied to these applications in the edition (most drugs have none)"},{"code":"NO_DATA","field":"controlled_schedule","reason":"no DEA schedule entry matched this drug's ingredient in the edition"},{"code":"NO_DATA","field":"safety_communication","reason":"no FDA Drug Safety Communication names this drug's ingredient in the edition"}],"disclaimer":"OmniRx is a reference layer of dated public facts, not clinical advice and not a guarantee of price, coverage or eligibility. Each answer lists the facts it rests on."}