{"answer":{"query":"Opsumit","resolved_as":"applications","packages":2,"applications":["NDA204410"],"identity":{"application_numbers":["NDA204410"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"TABLET, FILM COATED","untrusted":true}],"marketing_start":{"earliest":"2013-11-04","latest":"2013-11-04","packages_with_a_start_date":2}},"generic_entry":[{"application":"NDA204410","date":"2029-10-18","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":"8268847*PED","productNo":"001"},"latest_patent_expiry":"2029-10-18","latest_exclusivity_expiry":"2028-08-28","dated_barriers":12,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":5,"exclusivities_listed":2,"fact_id":"2d0c700cef53db5caafe1716"}],"label_history":{"events_total":23,"non_cmc_events":21,"counts_by_class":{"REMS":10,"EFFICACY":1,"LABELING":10},"cmc_events":2,"recent_non_cmc_events":[{"application":"NDA204410","submission_no":31,"class_code":"REMS","class_description":{"text":"REMS","untrusted":true},"status":"AP","date":"2025-04-02","documents":[{"type":"Label","date":"2025-04-03","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/204410s031lbl.pdf","untrusted":true}},{"type":"Letter","date":"2025-04-08","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/204410Orig1s031; 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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":"NDA204410","product_no":"001","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"OPSUMIT","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"10MG","untrusted":true}}]},"spending":{"reported_under":{"generic":{"text":"Macitentan","untrusted":true},"brand":{"text":"Opsumit","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":768656729.39,"claims":71967,"beneficiaries":8142,"average_spending_per_claim_usd":10680.683221,"fact_id":"339d96ef3fe59bbb93a742ca"},{"year":2021,"gross_spending_usd":863186477.77,"claims":77094,"beneficiaries":8815,"average_spending_per_claim_usd":11196.545487,"fact_id":"bf2cb4a941fda8c95ae4c82d"},{"year":2022,"gross_spending_usd":816890223.86,"claims":69167,"beneficiaries":8254,"average_spending_per_claim_usd":11810.40415,"fact_id":"f0518a2c277e7f5c90a1edf5"},{"year":2023,"gross_spending_usd":1018837122.8,"claims":79581,"beneficiaries":9031,"average_spending_per_claim_usd":12802.517219,"fact_id":"fa310a7d2b1ff5e5de7690ae"},{"year":2024,"gross_spending_usd":1231721758.3,"claims":97146,"beneficiaries":10962,"average_spending_per_claim_usd":12679.078483,"fact_id":"53831a81ac5d3b5b89e54e3e"}],"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}}},"rems":{"programs":[{"application":"NDA204410","program":{"text":"Macitentan-Containing Products","untrusted":true},"rems_id":"407","in_force":false,"released":true,"moved_to_shared_system":false,"has_etasu":true,"program_date":"2021-04-06","last_modified":"2025-04-02","source_page":"https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=407","other_programs":1,"read_on":"2026-11-07T20:05:28.959Z","fact_id":"bd24dec7bd3fa5355b6456f8"}],"reading":"what the FDA REMS@FDA files tie to the application on the read date; it does not say which prescribers or pharmacies take part or whether a patient needs the program"},"orphan_designation":{"ingredients":[{"ingredient":{"text":"macitentan","untrusted":true},"designation_count":4,"approved_count":1,"recent":[{"designated":"2017-06-15","use":{"text":"Treatment of chronic thromboembolic pulmonary hypertension (CTEPH)","untrusted":true},"status":"Designated/Designation Withdrawn or Revoked","sponsor":{"text":"Actelion Pharmaceuticals Ltd. 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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":"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":"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."}