{"answer":{"query":"Piqray","resolved_as":"applications","packages":5,"applications":["NDA212526"],"identity":{"application_numbers":["NDA212526"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"TABLET","untrusted":true},{"text":"KIT","untrusted":true}],"marketing_start":{"earliest":"2019-05-24","latest":"2019-05-24","packages_with_a_start_date":5}},"generic_entry":[{"application":"NDA212526","date":"2033-04-29","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":"8227462","productNo":"001"},"latest_patent_expiry":"2033-04-29","latest_exclusivity_expiry":"2027-01-18","dated_barriers":9,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":2,"exclusivities_listed":1,"fact_id":"17b22c8343c86429d47203b5"}],"label_history":{"events_total":6,"non_cmc_events":6,"counts_by_class":{"LABELING":4,"EFFICACY":2},"cmc_events":0,"recent_non_cmc_events":[{"application":"NDA212526","submission_no":11,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2026-10-28","documents":[{"type":"Letter","date":"2026-10-29","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/212526Orig1s011ltr.pdf","untrusted":true}},{"type":"Label","date":"2026-10-30","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/212526s011lbl.pdf","untrusted":true}}],"fact_id":"6215c56f5bef2106c027d4e2"},{"application":"NDA212526","submission_no":9,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2024-01-18","documents":[{"type":"Letter","date":"2024-01-19","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/212526Orig1s009ltr.pdf","untrusted":true}},{"type":"Label","date":"2024-01-19","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/212526s009lbl.pdf","untrusted":true}}],"fact_id":"d3b5b748cf225dcb8a332877"},{"application":"NDA212526","submission_no":7,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2022-11-22","documents":[{"type":"Label","date":"2022-11-23","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212526s007lbl.pdf","untrusted":true}},{"type":"Letter","date":"2022-11-25","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/212526Orig1s007ltr.pdf","untrusted":true}}],"fact_id":"1f77ad9d0aa17920c6453a68"},{"application":"NDA212526","submission_no":6,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2022-05-04","documents":[{"type":"Letter","date":"2022-05-05","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/212526Orig1s006ltr.pdf","untrusted":true}},{"type":"Label","date":"2022-05-06","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212526s006lbl.pdf","untrusted":true}}],"fact_id":"70974b985f46b3c8675b14d9"},{"application":"NDA212526","submission_no":4,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2021-07-20","documents":[{"type":"Label","date":"2021-07-21","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212526Orig1s004lbl.pdf","untrusted":true}},{"type":"Letter","date":"2021-07-22","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/212526Orig1s004ltr.pdf","untrusted":true}}],"fact_id":"e013562a72ba46f34a380e74"}],"note":"a dated list of FDA supplements and their classes, not a reading of what changed in the label"},"substitution":{"products_total":3,"te_code_counts":{"NOT_PROVIDED":3},"marketing_status_counts":{"Prescription":3},"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":"NDA212526","product_no":"003","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"PIQRAY","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"200MG","untrusted":true}},{"application":"NDA212526","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"PIQRAY","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"50MG","untrusted":true}},{"application":"NDA212526","product_no":"002","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"PIQRAY","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"150MG","untrusted":true}}]},"spending":{"reported_under":{"generic":{"text":"Alpelisib","untrusted":true},"brand":{"text":"Piqray","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":145606866.29,"claims":8735,"beneficiaries":2330,"average_spending_per_claim_usd":16669.360766,"fact_id":"7c09804597c162cf0936ab9f"},{"year":2021,"gross_spending_usd":124059404.14,"claims":6905,"beneficiaries":1779,"average_spending_per_claim_usd":17966.60451,"fact_id":"701545364ce61f910a236a26"},{"year":2022,"gross_spending_usd":122245171.2,"claims":6275,"beneficiaries":1615,"average_spending_per_claim_usd":19481.302183,"fact_id":"701debacf638d30e083b34ef"},{"year":2023,"gross_spending_usd":138440780.52,"claims":6641,"beneficiaries":1673,"average_spending_per_claim_usd":20846.375624,"fact_id":"a33272416fedbf615fed8310"},{"year":2024,"gross_spending_usd":109761431.63,"claims":5211,"beneficiaries":1177,"average_spending_per_claim_usd":21063.410407,"fact_id":"978749d6b93fc78c9bea37ce"}],"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":"Alpelisib; alpelisib","untrusted":true},"designation_count":3,"approved_count":2,"recent":[{"designated":"2023-03-21","use":{"text":"Treatment of lymphatic malformations","untrusted":true},"status":"Designated","sponsor":{"text":"Novartis Pharmaceuticals Corporation","untrusted":true},"approved":false},{"designated":"2019-11-18","use":{"text":"Treatment of PIK3CA-related overgrowth spectrum","untrusted":true},"status":"Designated/Approved","sponsor":{"text":"Novartis Pharmaceuticals Corporation","untrusted":true},"approved":true},{"designated":"2019-11-18","use":{"text":"Treatment of PIK3CA-related overgrowth spectrum","untrusted":true},"status":"Designated/Approved","sponsor":{"text":"Novartis Pharmaceuticals Corporation","untrusted":true},"approved":true}],"read_on":"2026-11-07T12:00:00.000Z","fact_id":"e6e0fdda3e9a50528be3850c"}],"reading":"a designation is not an approval and not a statement that the drug treats the condition; status is the FDA database's own"},"medicaid_state_utilization":{"year":2025,"states_with_data":1,"all_states_medicaid_reimbursed_usd":1542507.42,"all_states_medicaid_paid_prescriptions":65,"top_states":[{"state":"NY","medicaid_paid_prescriptions":65,"medicaid_reimbursed_usd":1542507.42,"total_reimbursed_usd":1542507.42,"packages":1,"covers":"all_record_types","fact_id":"0d9b2f04df5a32453d70aaa4"}],"unlabelled_state_code_xx":null,"built_from_facts":1,"facts_fee_for_service_only":0,"older_year_facts_not_used":5,"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). 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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":"8f0a3c17a44a5ccbf1ae77d8","field":"ndc.listing","entity":"ndc:00078070184"},{"fact_id":"90159f1f6e9934bc8d0f6247","field":"ndc.listing","entity":"ndc:00078070802"},{"fact_id":"ce26a70673c11bc69e6baaf1","field":"ndc.listing","entity":"ndc:00078070891"},{"fact_id":"17b22c8343c86429d47203b5","field":"drug.generic_entry_earliest","entity":"application:NDA212526"},{"fact_id":"7b051dc462f8a79b90d65c0b","field":"drug.patent","entity":"application:NDA212526"},{"fact_id":"12204b27c5e813c791845323","field":"drug.exclusivity","entity":"application:NDA212526"},{"fact_id":"6215c56f5bef2106c027d4e2","field":"drug.label_event","entity":"application:NDA212526"},{"fact_id":"d3b5b748cf225dcb8a332877","field":"drug.label_event","entity":"application:NDA212526"},{"fact_id":"1f77ad9d0aa17920c6453a68","field":"drug.label_event","entity":"application:NDA212526"},{"fact_id":"70974b985f46b3c8675b14d9","field":"drug.label_event","entity":"application:NDA212526"},{"fact_id":"e013562a72ba46f34a380e74","field":"drug.label_event","entity":"application:NDA212526"},{"fact_id":"b5a5ad3491ef984b37d3d340","field":"drug.marketing_status","entity":"application:NDA212526"},{"fact_id":"4d20798ea9d4aabd9925c1b4","field":"drug.marketing_status","entity":"application:NDA212526"},{"fact_id":"3732129544e5d29ce3e1dd28","field":"drug.marketing_status","entity":"application:NDA212526"},{"fact_id":"7c09804597c162cf0936ab9f","field":"drug.partd_spending","entity":"drug:alpelisib|piqray"},{"fact_id":"701545364ce61f910a236a26","field":"drug.partd_spending","entity":"drug:alpelisib|piqray"},{"fact_id":"701debacf638d30e083b34ef","field":"drug.partd_spending","entity":"drug:alpelisib|piqray"},{"fact_id":"a33272416fedbf615fed8310","field":"drug.partd_spending","entity":"drug:alpelisib|piqray"},{"fact_id":"978749d6b93fc78c9bea37ce","field":"drug.partd_spending","entity":"drug:alpelisib|piqray"},{"fact_id":"e6e0fdda3e9a50528be3850c","field":"drug.orphan_designation","entity":"drug:alpelisib"},{"fact_id":"0d9b2f04df5a32453d70aaa4","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00078070802:NY"}],"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":"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."}