{"answer":{"query":"Brilinta","resolved_as":"applications","packages":6,"applications":["NDA022433"],"identity":{"application_numbers":["NDA022433"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"TABLET","untrusted":true}],"marketing_start":{"earliest":"2011-08-05","latest":"2024-04-03","packages_with_a_start_date":6}},"generic_entry":[{"application":"NDA022433","date":"2036-07-27","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":"10300065*PED","productNo":"002"},"latest_patent_expiry":"2036-07-27","latest_exclusivity_expiry":"NOT_PROVIDED","dated_barriers":8,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":2,"exclusivities_listed":0,"fact_id":"188879b1158549d9900a8800"}],"label_history":{"events_total":28,"non_cmc_events":22,"counts_by_class":{"LABELING":15,"EFFICACY":6,"REMS":1},"cmc_events":6,"recent_non_cmc_events":[{"application":"NDA022433","submission_no":39,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2026-05-07","documents":[{"type":"Letter","date":"2026-05-11","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/022433Orig1s039ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-05-18","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/022433s039lbl.pdf","untrusted":true}}],"fact_id":"7b7c08da429b2ef7ffabf6fc"},{"application":"NDA022433","submission_no":37,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2024-11-04","documents":[{"type":"Label","date":"2024-11-05","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022433s037lbl.pdf","untrusted":true}},{"type":"Letter","date":"2024-11-05","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/022433Orig1s037ltr.pdf","untrusted":true}}],"fact_id":"ea76d2041bb4a920b0145343"},{"application":"NDA022433","submission_no":35,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2024-03-22","documents":[{"type":"Letter","date":"2024-03-25","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/022433Orig1s035ltr.pdf","untrusted":true}},{"type":"Label","date":"2024-03-25","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022433s035lbl.pdf","untrusted":true}}],"fact_id":"4951a017d9bf0c138c201a17"},{"application":"NDA022433","submission_no":34,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2022-05-09","documents":[{"type":"Letter","date":"2022-05-10","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022433Orig1s034ltr.pdf","untrusted":true}},{"type":"Label","date":"2022-05-11","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022433s034lbl.pdf","untrusted":true}}],"fact_id":"40f9fda1b1878b046a787255"},{"application":"NDA022433","submission_no":32,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2021-08-10","documents":[{"type":"Letter","date":"2021-08-11","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022433Orig1s032ltr.pdf","untrusted":true}},{"type":"Label","date":"2021-08-11","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022433s032lbl.pdf","untrusted":true}}],"fact_id":"34ba1f0c0dddec430b480ba6"}],"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":2},"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":"NDA022433","product_no":"001","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"BRILINTA","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"90MG","untrusted":true}},{"application":"NDA022433","product_no":"002","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"BRILINTA","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"60MG","untrusted":true}}]},"recalls":{"recalls_total":2,"counts_by_class":{"Class II":1,"Class I":1},"packages_of_these_applications":6,"most_recent":[{"recall_number":"D-0433-2021","classification":"Class II","status":"Terminated","report_date":"2021-06-02","recall_initiated":"2021-03-15","recalling_firm":{"text":"Cardinal Health Inc.","untrusted":true},"reason":{"text":"CGMP Deviations: Intermittent exposure to temperature excursion during storage.","untrusted":true},"packages_named":3,"fact_id":"fbc1d131f752a42a8e494944"},{"recall_number":"D-0958-2017","classification":"Class I","status":"Terminated","report_date":"2017-07-19","recall_initiated":"2017-05-25","recalling_firm":{"text":"AstraZeneca Pharmaceuticals, LP","untrusted":true},"reason":{"text":"Presence of Foriegn Tablets/Capsules: customer complaint that an 8-count professional sample bottle labeled as BRILINTA 90 mg tablets contained 5 ZURAMPIC 200 mg tablets, in addition to the expected 8 BRILINTA tablets.","untrusted":true},"packages_named":3,"fact_id":"9fa6a7cdf83f7ee7b45d5bcb"}],"meaning":"FDA classifies the health hazard of a recall, not its effect on supply"},"spending":{"reported_under":{"generic":{"text":"Ticagrelor","untrusted":true},"brand":{"text":"Brilinta","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":588513924.14,"claims":1017116,"beneficiaries":221308,"average_spending_per_claim_usd":578.61042805,"fact_id":"54ec3737a7c8dc841400aa96"},{"year":2021,"gross_spending_usd":602371202.85,"claims":954211,"beneficiaries":220718,"average_spending_per_claim_usd":631.27673319,"fact_id":"449509fe35010f1503dee5cb"},{"year":2022,"gross_spending_usd":638382092.33,"claims":945803,"beneficiaries":223308,"average_spending_per_claim_usd":674.9630656,"fact_id":"25b440c3d892824764c840a8"},{"year":2023,"gross_spending_usd":691725954.38,"claims":980952,"beneficiaries":234770,"average_spending_per_claim_usd":705.15780016,"fact_id":"f0347cdb2c5001424f8caf71"},{"year":2024,"gross_spending_usd":685497436.89,"claims":1029007,"beneficiaries":242931,"average_spending_per_claim_usd":666.17373535,"fact_id":"626d8dea6e06abe79eb35876"}],"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":"NDA022433","program":{"text":"Brilinta","untrusted":true},"rems_id":"8","in_force":false,"released":true,"moved_to_shared_system":false,"has_etasu":false,"program_date":"2011-07-20","last_modified":"2013-10-30","source_page":"https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=8","other_programs":0,"read_on":"2026-11-07T20:05:28.959Z","fact_id":"34d7289572b614d230b7b51a"}],"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"},"medicaid_state_utilization":{"year":2025,"states_with_data":1,"all_states_medicaid_reimbursed_usd":28080.67,"all_states_medicaid_paid_prescriptions":63,"top_states":[{"state":"ID","medicaid_paid_prescriptions":63,"medicaid_reimbursed_usd":28080.67,"total_reimbursed_usd":28086.67,"packages":1,"covers":"all_record_types","fact_id":"3255ea955cafaa07eaa0e687"}],"unlabelled_state_code_xx":null,"built_from_facts":1,"facts_fee_for_service_only":0,"older_year_facts_not_used":101,"dataset":"State Drug Utilization Data 2025","read_on":"2026-11-07T22:41:44.201Z","reading":"Medicaid prescriptions and reimbursement by state (CMS State Drug Utilization Data). 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":"bea96478daac2fc2973eb0d4","field":"ndc.listing","entity":"ndc:00186077660"},{"fact_id":"3d2de3c973a47a6ff342b8fb","field":"ndc.listing","entity":"ndc:00186077739"},{"fact_id":"8e8e0561d7c6759b9437268e","field":"ndc.listing","entity":"ndc:00186077760"},{"fact_id":"188879b1158549d9900a8800","field":"drug.generic_entry_earliest","entity":"application:NDA022433"},{"fact_id":"0a5c685dde44a221c4f369aa","field":"drug.patent","entity":"application:NDA022433"},{"fact_id":"7b7c08da429b2ef7ffabf6fc","field":"drug.label_event","entity":"application:NDA022433"},{"fact_id":"ea76d2041bb4a920b0145343","field":"drug.label_event","entity":"application:NDA022433"},{"fact_id":"4951a017d9bf0c138c201a17","field":"drug.label_event","entity":"application:NDA022433"},{"fact_id":"40f9fda1b1878b046a787255","field":"drug.label_event","entity":"application:NDA022433"},{"fact_id":"34ba1f0c0dddec430b480ba6","field":"drug.label_event","entity":"application:NDA022433"},{"fact_id":"bec48fbe978d67105f116e17","field":"drug.te_code","entity":"application:NDA022433"},{"fact_id":"8abca92cc415c39d5654d368","field":"drug.marketing_status","entity":"application:NDA022433"},{"fact_id":"1242089baeb8db16691f2c21","field":"drug.te_code","entity":"application:NDA022433"},{"fact_id":"ef962698790338ad43daded5","field":"drug.marketing_status","entity":"application:NDA022433"},{"fact_id":"fbc1d131f752a42a8e494944","field":"ndc.recall","entity":"ndc:00186077739"},{"fact_id":"9fa6a7cdf83f7ee7b45d5bcb","field":"ndc.recall","entity":"ndc:00186077660"},{"fact_id":"54ec3737a7c8dc841400aa96","field":"drug.partd_spending","entity":"drug:ticagrelor|brilinta"},{"fact_id":"449509fe35010f1503dee5cb","field":"drug.partd_spending","entity":"drug:ticagrelor|brilinta"},{"fact_id":"25b440c3d892824764c840a8","field":"drug.partd_spending","entity":"drug:ticagrelor|brilinta"},{"fact_id":"f0347cdb2c5001424f8caf71","field":"drug.partd_spending","entity":"drug:ticagrelor|brilinta"},{"fact_id":"626d8dea6e06abe79eb35876","field":"drug.partd_spending","entity":"drug:ticagrelor|brilinta"},{"fact_id":"34d7289572b614d230b7b51a","field":"drug.rems","entity":"application:NDA022433"},{"fact_id":"3255ea955cafaa07eaa0e687","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00186077660:ID"}],"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":"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":"orphan_designation","reason":"no FDA orphan designation for this drug's ingredient is 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."}