{"answer":{"query":"Xphozah","resolved_as":"applications","packages":9,"applications":["NDA213931"],"identity":{"application_numbers":["NDA213931"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"TABLET, FILM COATED","untrusted":true}],"marketing_start":{"earliest":"2023-10-17","latest":"2023-10-17","packages_with_a_start_date":9}},"generic_entry":[{"application":"NDA213931","date":"2042-11-26","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":"12539299","productNo":"001"},"latest_patent_expiry":"2042-11-26","latest_exclusivity_expiry":"2026-10-17","dated_barriers":21,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":6,"exclusivities_listed":1,"fact_id":"ba6d1cdfef908f5c97ac078b"}],"label_history":{"events_total":2,"non_cmc_events":2,"counts_by_class":{"LABELING":2},"cmc_events":0,"recent_non_cmc_events":[{"application":"NDA213931","submission_no":5,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-06-16","documents":[{"type":"Label","date":"2025-06-17","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/213931s005lbl.pdf","untrusted":true}},{"type":"Letter","date":"2025-06-17","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/213931Orig1s005ltr.pdf","untrusted":true}}],"fact_id":"3f5d53d57c58d0cc66173e44"},{"application":"NDA213931","submission_no":2,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-03-21","documents":[{"type":"Label","date":"2025-03-24","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/213931s002lbl.pdf","untrusted":true}},{"type":"Letter","date":"2025-03-25","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/213931Orig1s002ltr.pdf","untrusted":true}}],"fact_id":"00469e55974705fda768d8b3"}],"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":2,"Discontinued":1},"meaning":"raw FDA codes; 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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":"df5d98d1faf7f4bb5bf58fe0","field":"ndc.listing","entity":"ndc:73154011014"},{"fact_id":"5cf0e640b39a9c1974163e12","field":"ndc.listing","entity":"ndc:73154011060"},{"fact_id":"89bfe0c1f85ab9ede58479a4","field":"ndc.listing","entity":"ndc:73154011099"},{"fact_id":"ba6d1cdfef908f5c97ac078b","field":"drug.generic_entry_earliest","entity":"application:NDA213931"},{"fact_id":"5d89b861d9bba08ddba02a1c","field":"drug.patent","entity":"application:NDA213931"},{"fact_id":"91b7ecd0e4d103bfd5aeee0c","field":"drug.exclusivity","entity":"application:NDA213931"},{"fact_id":"3f5d53d57c58d0cc66173e44","field":"drug.label_event","entity":"application:NDA213931"},{"fact_id":"00469e55974705fda768d8b3","field":"drug.label_event","entity":"application:NDA213931"},{"fact_id":"e902afefd28c307fffc7d01e","field":"drug.marketing_status","entity":"application:NDA213931"},{"fact_id":"a5eceb4130c3a37b242f0826","field":"drug.marketing_status","entity":"application:NDA213931"},{"fact_id":"28df150a1574d34ba3d27d00","field":"drug.marketing_status","entity":"application:NDA213931"},{"fact_id":"911c87226903db5bee8e735e","field":"drug.partd_spending","entity":"drug:tenapanor-hcl|xphozah"},{"fact_id":"49fa06da6380642a965c4d49","field":"drug.partd_spending","entity":"drug:tenapanor-hcl|xphozah"},{"fact_id":"465fcb22bb62858a54a037fc","field":"ndc.medicaid_state_utilization","entity":"ndc_state:73154012060:CA"},{"fact_id":"0e30a470b65b11789999eeda","field":"ndc.medicaid_state_utilization","entity":"ndc_state:73154013060:OH"},{"fact_id":"5be7c3414f3899ceb69b90ca","field":"ndc.medicaid_state_utilization","entity":"ndc_state:73154013060:TX"},{"fact_id":"86c132b4d2a686bb689ca4eb","field":"ndc.medicaid_state_utilization","entity":"ndc_state:73154013060:IN"},{"fact_id":"431583294c054c0d2be4c2d9","field":"ndc.medicaid_state_utilization","entity":"ndc_state:73154012060:NY"},{"fact_id":"8141ced3693620f2bc45364c","field":"ndc.medicaid_state_utilization","entity":"ndc_state:73154013060:KY"},{"fact_id":"f008b7866e5cbf48220ddb10","field":"ndc.medicaid_state_utilization","entity":"ndc_state:73154013060:NC"},{"fact_id":"08cd93f25fa4dc89a141787b","field":"ndc.medicaid_state_utilization","entity":"ndc_state:73154013060:FL"},{"fact_id":"60ed536a8d0e6c2542277b67","field":"ndc.medicaid_state_utilization","entity":"ndc_state:73154013060:NV"},{"fact_id":"9cea1587504910f702f83d5d","field":"ndc.medicaid_state_utilization","entity":"ndc_state:73154012060:IL"}],"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":"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."}