{"answer":{"query":"Adempas","resolved_as":"applications","packages":17,"applications":["NDA204819"],"identity":{"application_numbers":["NDA204819"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"TABLET, FILM COATED","untrusted":true}],"marketing_start":{"earliest":"2013-10-08","latest":"2014-09-18","packages_with_a_start_date":17}},"generic_entry":[{"application":"NDA204819","date":"2034-02-18","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":"10662188","productNo":"001"},"latest_patent_expiry":"2034-02-18","latest_exclusivity_expiry":"NOT_PROVIDED","dated_barriers":20,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":4,"exclusivities_listed":0,"fact_id":"f5b95bb61d9ae43338897918"}],"label_history":{"events_total":14,"non_cmc_events":13,"counts_by_class":{"REMS":9,"LABELING":3,"EFFICACY":1},"cmc_events":1,"recent_non_cmc_events":[{"application":"NDA204819","submission_no":19,"class_code":"REMS","class_description":{"text":"REMS","untrusted":true},"status":"AP","date":"2026-08-04","documents":[{"type":"Letter","date":"2026-08-06","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/204819Orig1s019ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-08-12","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/204819s019lbl.pdf","untrusted":true}}],"fact_id":"e75ddafd16da3cac36244eea"},{"application":"NDA204819","submission_no":20,"class_code":"REMS","class_description":{"text":"REMS","untrusted":true},"status":"AP","date":"2026-05-08","documents":[{"type":"Letter","date":"2026-05-11","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/204819Orig1s020ltr.pdf","untrusted":true}}],"fact_id":"9d4a86d7616009b066c9c6b9"},{"application":"NDA204819","submission_no":15,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2021-09-10","documents":[{"type":"Label","date":"2021-09-13","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/204819s015lbl.pdf","untrusted":true}},{"type":"Letter","date":"2021-09-14","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/204819Orig1s015ltr.pdf","untrusted":true}}],"fact_id":"d6b614dc02abb9f3bd42dea5"},{"application":"NDA204819","submission_no":13,"class_code":"REMS","class_description":{"text":"REMS","untrusted":true},"status":"AP","date":"2020-11-30","documents":[{"type":"Letter","date":"2020-12-02","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/204819Orig1s013ltr.pdf","untrusted":true}}],"fact_id":"2a19c3ff1dd70d1ebd9f6eef"},{"application":"NDA204819","submission_no":14,"class_code":"REMS","class_description":{"text":"REMS","untrusted":true},"status":"AP","date":"2020-02-10","documents":[{"type":"Letter","date":"2020-02-12","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/204819Orig1s014ltr.pdf","untrusted":true}}],"fact_id":"e562ee54fb28f74b4d5518bf"}],"note":"a dated list of FDA supplements and their classes, not a reading of what changed in the label"},"substitution":{"products_total":5,"te_code_counts":{"AB":5},"marketing_status_counts":{"Prescription":5},"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":"NDA204819","product_no":"003","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"ADEMPAS","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"1.5MG","untrusted":true}},{"application":"NDA204819","product_no":"004","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"ADEMPAS","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"2MG","untrusted":true}},{"application":"NDA204819","product_no":"002","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"ADEMPAS","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"1MG","untrusted":true}},{"application":"NDA204819","product_no":"001","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"ADEMPAS","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"0.5MG","untrusted":true}},{"application":"NDA204819","product_no":"005","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"ADEMPAS","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"2.5MG","untrusted":true}}]},"spending":{"reported_under":{"generic":{"text":"Riociguat","untrusted":true},"brand":{"text":"Adempas","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":463152406.38,"claims":41615,"beneficiaries":4645,"average_spending_per_claim_usd":11129.458281,"fact_id":"61ef0fd4dc06a5b49539ad47"},{"year":2021,"gross_spending_usd":566502537.42,"claims":47886,"beneficiaries":5431,"average_spending_per_claim_usd":11830.233,"fact_id":"701c8976e41621f2d1f6a18b"},{"year":2022,"gross_spending_usd":576981088.02,"claims":45851,"beneficiaries":5240,"average_spending_per_claim_usd":12583.82779,"fact_id":"9395a3bb2573b04be98e2bd6"},{"year":2023,"gross_spending_usd":598223220.35,"claims":44483,"beneficiaries":4980,"average_spending_per_claim_usd":13448.356009,"fact_id":"e7dc07a4f3ed587d3d2ee9fd"},{"year":2024,"gross_spending_usd":694246753.36,"claims":50847,"beneficiaries":5553,"average_spending_per_claim_usd":13653.642366,"fact_id":"429015b6cb8d187ea21e4f4e"}],"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":"NDA204819","program":{"text":"Adempas","untrusted":true},"rems_id":"149","in_force":false,"released":true,"moved_to_shared_system":false,"has_etasu":true,"program_date":"2013-10-08","last_modified":"2026-08-04","source_page":"https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=149","other_programs":1,"read_on":"2026-11-07T20:05:28.959Z","fact_id":"24cbc12decf2c7aa094087c4"}],"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":"riociguat","untrusted":true},"designation_count":4,"approved_count":2,"recent":[{"designated":"2019-06-26","use":{"text":"Treatment of Fontan-palliated patients","untrusted":true},"status":"Designated/Designation Withdrawn or Revoked","sponsor":{"text":"Bayer U.S. LLC","untrusted":true},"approved":false},{"designated":"2014-07-24","use":{"text":"Treatment of systemic sclerosis","untrusted":true},"status":"Designated/Designation Withdrawn or Revoked","sponsor":{"text":"Bayer HealthCare Pharmaceuticals, Inc.","untrusted":true},"approved":false},{"designated":"2013-09-19","use":{"text":"Treatment of chronic thromboembolic pulmonary hypertension","untrusted":true},"status":"Designated/Approved","sponsor":{"text":"Bayer HealthCare Pharmaceuticals, Inc.","untrusted":true},"approved":true},{"designated":"2013-09-19","use":{"text":"Treatment of pulmonary arterial hypertension.","untrusted":true},"status":"Designated/Approved","sponsor":{"text":"Bayer HealthCare Pharmaceuticals, Inc.","untrusted":true},"approved":true}],"read_on":"2026-11-07T12:00:00.000Z","fact_id":"59f34da1888e5c36a86509d4"}],"reading":"a designation is not an approval and not a statement that the drug treats the condition; 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Reimbursement is before manufacturer rebates: not a net cost, not a patient price. Suppressed managed-care cells make a state figure fee-for-service only. An absent state was suppressed or unreported, not zero.","receipts_note":"a receipt is held for the largest fact behind each state shown; every figure is a sum of the built_from_facts facts, each recomputable from its recorded input hash"}},"receipts":[{"fact_id":"fe5eb41bcd3df3c844f73060","field":"ndc.listing","entity":"ndc:50419025001"},{"fact_id":"a569116d672272d12c370bfe","field":"ndc.listing","entity":"ndc:50419025003"},{"fact_id":"ff9d0a49a2ec321366ed0c76","field":"ndc.listing","entity":"ndc:50419025071"},{"fact_id":"f5b95bb61d9ae43338897918","field":"drug.generic_entry_earliest","entity":"application:NDA204819"},{"fact_id":"a1bc35722288da68610ef046","field":"drug.patent","entity":"application:NDA204819"},{"fact_id":"e75ddafd16da3cac36244eea","field":"drug.label_event","entity":"application:NDA204819"},{"fact_id":"9d4a86d7616009b066c9c6b9","field":"drug.label_event","entity":"application:NDA204819"},{"fact_id":"d6b614dc02abb9f3bd42dea5","field":"drug.label_event","entity":"application:NDA204819"},{"fact_id":"2a19c3ff1dd70d1ebd9f6eef","field":"drug.label_event","entity":"application:NDA204819"},{"fact_id":"e562ee54fb28f74b4d5518bf","field":"drug.label_event","entity":"application:NDA204819"},{"fact_id":"89da4f848a2b2b06acb4c89a","field":"drug.te_code","entity":"application:NDA204819"},{"fact_id":"aa4e437aa99142e429c14aeb","field":"drug.marketing_status","entity":"application:NDA204819"},{"fact_id":"3bfaec09fef127fe09df37f4","field":"drug.te_code","entity":"application:NDA204819"},{"fact_id":"91e762c2a06014734dfce514","field":"drug.marketing_status","entity":"application:NDA204819"},{"fact_id":"27ef10f70d40703d1d18c21a","field":"drug.te_code","entity":"application:NDA204819"},{"fact_id":"201724cc3c8cf89277cc352b","field":"drug.marketing_status","entity":"application:NDA204819"},{"fact_id":"137baf9ea00873f71014a70f","field":"drug.te_code","entity":"application:NDA204819"},{"fact_id":"2dfcbf89531ab0c7f85aa96d","field":"drug.marketing_status","entity":"application:NDA204819"},{"fact_id":"020a8dc68f76255a07d5fa09","field":"drug.te_code","entity":"application:NDA204819"},{"fact_id":"20442533467a2b0e431a8934","field":"drug.marketing_status","entity":"application:NDA204819"},{"fact_id":"61ef0fd4dc06a5b49539ad47","field":"drug.partd_spending","entity":"drug:riociguat|adempas"},{"fact_id":"701c8976e41621f2d1f6a18b","field":"drug.partd_spending","entity":"drug:riociguat|adempas"},{"fact_id":"9395a3bb2573b04be98e2bd6","field":"drug.partd_spending","entity":"drug:riociguat|adempas"},{"fact_id":"e7dc07a4f3ed587d3d2ee9fd","field":"drug.partd_spending","entity":"drug:riociguat|adempas"},{"fact_id":"429015b6cb8d187ea21e4f4e","field":"drug.partd_spending","entity":"drug:riociguat|adempas"},{"fact_id":"24cbc12decf2c7aa094087c4","field":"drug.rems","entity":"application:NDA204819"},{"fact_id":"59f34da1888e5c36a86509d4","field":"drug.orphan_designation","entity":"drug:riociguat"},{"fact_id":"a31abee8c7e545437bfc8115","field":"ndc.medicaid_state_utilization","entity":"ndc_state:50419025301:OH"}],"as_of":{"newest_fact_retrieved_at":"2026-11-10T20:02:39.475Z"},"edition":{"id":"2026-11","merkleRoot":"006ab9a329709cbe7f56a0e1a7c4a02f897655cdfecf9ca34d199690095adcb6","factCount":212100,"manifestPresent":true},"licence":{"classes":["GREEN"],"note":"Source records are public; this compilation is cited with attribution. 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."}