{"answer":{"query":"linzess","resolved_as":"name","packages":3,"applications":["NDA202811"],"identity":{"application_numbers":["NDA202811"],"marketing_categories":["NDA"],"labelers":[{"text":"ALLERGAN, INC.","untrusted":true}],"dosage_forms":[{"text":"CAPSULE, GELATIN COATED","untrusted":true}],"marketing_start":{"earliest":"2012-09-08","latest":"2017-01-30","packages_with_a_start_date":3}},"price":{"median_negotiated_over_nadac":null,"packages_compared":0,"packages_listed":3,"negotiated_price_ends":null,"rows":[{"ndc":"00456120130","name":{"text":"LINZESS 145 MCG 30 CT","untrusted":true},"class":"B","nadac_per_unit":9.01854,"negotiated_per_unit":null,"ratio":null,"ful_per_unit":null},{"ndc":"00456120230","name":{"text":"LINZESS 290 MCG 30 CT","untrusted":true},"class":"B","nadac_per_unit":9.01398,"negotiated_per_unit":null,"ratio":null,"ful_per_unit":null},{"ndc":"00456120330","name":{"text":"LINZESS 72MCG","untrusted":true},"class":"B","nadac_per_unit":9.00989,"negotiated_per_unit":null,"ratio":null,"ful_per_unit":null}],"negotiated_scheduled":{"thirty_day":136,"effective":"2027-01-01"}},"generic_entry":[{"application":"NDA202811","date":"2034-02-16","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":"9708371*PED","productNo":"002"},"latest_patent_expiry":"2034-02-16","latest_exclusivity_expiry":"2029-05-21","dated_barriers":35,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":7,"exclusivities_listed":4,"fact_id":"862a18edc96219b892e86ea8"}],"label_history":{"events_total":19,"non_cmc_events":13,"counts_by_class":{"EFFICACY":5,"LABELING":8},"cmc_events":6,"recent_non_cmc_events":[{"application":"NDA202811","submission_no":23,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2026-05-21","documents":[{"type":"Label","date":"2026-05-26","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/202811s023lbl.pdf","untrusted":true}},{"type":"Letter","date":"2026-05-26","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/202811Orig1s023ltr.pdf","untrusted":true}}],"fact_id":"d28374f9e347242b1bb7598c"},{"application":"NDA202811","submission_no":22,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2025-11-04","documents":[{"type":"Label","date":"2025-11-05","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/202811s022lbl.pdf","untrusted":true}},{"type":"Letter","date":"2025-11-05","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/202811Orig1s022ltr.pdf","untrusted":true}}],"fact_id":"a2e8e7f3095653aa7f7494e4"},{"application":"NDA202811","submission_no":21,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2023-06-12","documents":[{"type":"Letter","date":"2023-06-13","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/202811Orig1s021ltr.pdf","untrusted":true}},{"type":"Label","date":"2023-06-13","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202811s021lbl.pdf","untrusted":true}}],"fact_id":"399d8bf493f02d753dcf1597"},{"application":"NDA202811","submission_no":18,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2021-08-24","documents":[{"type":"Letter","date":"2021-08-26","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/202811Orig1s018ltr.pdf","untrusted":true}},{"type":"Label","date":"2021-08-26","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202811s018lbl.pdf","untrusted":true}}],"fact_id":"e44aa63b3f177577428ddeec"},{"application":"NDA202811","submission_no":17,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2021-04-12","documents":[{"type":"Letter","date":"2021-04-13","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/202811Orig1s017ltr.pdf","untrusted":true}},{"type":"Label","date":"2021-04-15","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202811s017lbl.pdf","untrusted":true}}],"fact_id":"07ebf15048c4004a81db5302"}],"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":{"AB":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":"NDA202811","product_no":"003","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"LINZESS","untrusted":true},"form":{"text":"CAPSULE;ORAL","untrusted":true},"strength":{"text":"72MCG","untrusted":true}},{"application":"NDA202811","product_no":"001","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"LINZESS","untrusted":true},"form":{"text":"CAPSULE;ORAL","untrusted":true},"strength":{"text":"145MCG","untrusted":true}},{"application":"NDA202811","product_no":"002","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"LINZESS","untrusted":true},"form":{"text":"CAPSULE;ORAL","untrusted":true},"strength":{"text":"290MCG","untrusted":true}}]},"recalls":{"recalls_total":1,"counts_by_class":{"Class II":1},"packages_of_these_applications":3,"most_recent":[{"recall_number":"D-0417-2021","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":1,"fact_id":"7dca799a94dd1bc7bb46a186"}],"meaning":"FDA classifies the health hazard of a recall, not its effect on supply"},"trials":{"attribution":"Source: ClinicalTrials.gov","modification_statement":"OmniRx has summarized and trimmed this ClinicalTrials.gov data.","not_an_offer":"A recruiting trial listing is not an offer of free drug and not medical advice; enrollment is decided by the study team.","ingredients":[{"ingredient":{"text":"LINACLOTIDE","untrusted":true},"recruiting_interventional_count":3,"not_yet_recruiting_count":2,"by_phase":{"NA":1,"EARLY_PHASE1":1,"PHASE1/PHASE2":1},"registry_processing_date":"2026-11-06T10:00:05","modifications":"Counts and phase tallies computed here from the full recruiting result set; trials trimmed to the 25 most recently updated, conditions to 3, countries to 10 distinct; no text edited.","recent_trials":[{"nct_id":"NCT05796388","title":{"text":"A Study of Virtual Reality and Linaclotide for IBS-C","untrusted":true},"phase":["NA"],"sponsor":{"text":"Mayo Clinic","untrusted":true},"status":"RECRUITING","last_update_posted":"2026-07-29","start_date":"2024-05-31","link":{"text":"https://clinicaltrials.gov/study/NCT05796388","untrusted":true}},{"nct_id":"NCT07569419","title":{"text":"Proof of Principle Study for an Efficacy Trial of Linaclotide for Cystic Fibrosis","untrusted":true},"phase":["EARLY_PHASE1"],"sponsor":{"text":"University of Nottingham","untrusted":true},"status":"RECRUITING","last_update_posted":"2026-05-06","start_date":"2026-03-09","link":{"text":"https://clinicaltrials.gov/study/NCT07569419","untrusted":true}},{"nct_id":"NCT06692673","title":{"text":"Linaclotide for Colonoscopy Bowel Prep","untrusted":true},"phase":["PHASE1","PHASE2"],"sponsor":{"text":"University of Florida","untrusted":true},"status":"RECRUITING","last_update_posted":"2026-01-23","start_date":"2025-12-01","link":{"text":"https://clinicaltrials.gov/study/NCT06692673","untrusted":true}}],"fact_id":"3dbc0f5b135ffdc585640dae"}]},"assistance_and_offers":{"programs_listing_this_drug":[],"manufacturer_offers":[{"program":"linzess-savings-card","kind":"copay_card","price_figures":{"payAsLittleAs":30,"supplyLengths":"30, 60 or 90-day supply","maxFillsPerCalendarYear":12,"maxAnnualBenefit":2280},"conditions":{"text":"The page states the offer is valid only for patients with commercial prescription insurance coverage, not for cash-paying patients or government-program enrollees; a 60-day supply counts as two fills and a 90-day supply as three.","untrusted":true},"limited_time":false,"expires_note":null,"stated_end_date":null,"expired":false,"detail":{"text":"The LINZESS savings page states pay as little as $30 per 30, 60 or 90-day supply for each of up to twelve prescription fills per calendar year, with a maximum annual benefit of $2,280.00 per calendar year, for commercially insured patients. No end date is stated.","untrusted":true},"read_on":"2026-11-07T07:23:55.567Z","source_url":"https://www.linzess.com/savings-and-support","proof_state":"verified","fact_id":"e01921fefd5ba8ef978c8f57"}],"note":"A program that lists a drug has not decided anything about any person: each program decides who qualifies, and a status other than open means it may not take new patients. Offers change and expire; read each offer's source and stated end date. A price figure is what the page states, not a quote."},"spending":{"reported_under":{"generic":{"text":"Linaclotide","untrusted":true},"brand":{"text":"Linzess","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":1144468127.9,"claims":1820879,"beneficiaries":428018,"average_spending_per_claim_usd":628.5250848,"fact_id":"a315bc673487edd8a4a3f823"},{"year":2021,"gross_spending_usd":1374354960.6,"claims":2005937,"beneficiaries":481655,"average_spending_per_claim_usd":685.14363142,"fact_id":"dbc30d2cfb6e2398c8522eac"},{"year":2022,"gross_spending_usd":1581669987.3,"claims":2113198,"beneficiaries":510755,"average_spending_per_claim_usd":748.47221476,"fact_id":"dd1d09ab7470f7f086a9d000"},{"year":2023,"gross_spending_usd":1825245843.2,"claims":2263018,"beneficiaries":565088,"average_spending_per_claim_usd":806.55383353,"fact_id":"e360fba168a4ac34ef5dc33c"},{"year":2024,"gross_spending_usd":1981958629.2,"claims":2506531,"beneficiaries":632063,"average_spending_per_claim_usd":790.71778054,"fact_id":"9f1ee711ac9e8e4eed2209a2"}],"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}}},"medicaid_state_utilization":{"year":2025,"states_with_data":2,"all_states_medicaid_reimbursed_usd":487765.31,"all_states_medicaid_paid_prescriptions":715,"top_states":[{"state":"NH","medicaid_paid_prescriptions":654,"medicaid_reimbursed_usd":451941.1,"total_reimbursed_usd":451941.1,"packages":1,"covers":"fee_for_service_only","fact_id":"fefc9c8ac1f8272a93b50e08"},{"state":"PR","medicaid_paid_prescriptions":61,"medicaid_reimbursed_usd":35824.21,"total_reimbursed_usd":37837.49,"packages":1,"covers":"all_record_types","fact_id":"d75c067e818a9f7d706698e3"}],"unlabelled_state_code_xx":null,"built_from_facts":2,"facts_fee_for_service_only":1,"older_year_facts_not_used":157,"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":"9d3d97d55f26beb27c2601a5","field":"ndc.listing","entity":"ndc:00456120130"},{"fact_id":"8517c15f780412b263a0e56d","field":"ndc.listing","entity":"ndc:00456120230"},{"fact_id":"c4ace58fd393a66a802d19f4","field":"ndc.listing","entity":"ndc:00456120330"},{"fact_id":"862a18edc96219b892e86ea8","field":"drug.generic_entry_earliest","entity":"application:NDA202811"},{"fact_id":"5416b63848a43c250c786eac","field":"drug.patent","entity":"application:NDA202811"},{"fact_id":"0e97742bc71464daaa9fadbf","field":"drug.exclusivity","entity":"application:NDA202811"},{"fact_id":"d28374f9e347242b1bb7598c","field":"drug.label_event","entity":"application:NDA202811"},{"fact_id":"a2e8e7f3095653aa7f7494e4","field":"drug.label_event","entity":"application:NDA202811"},{"fact_id":"399d8bf493f02d753dcf1597","field":"drug.label_event","entity":"application:NDA202811"},{"fact_id":"e44aa63b3f177577428ddeec","field":"drug.label_event","entity":"application:NDA202811"},{"fact_id":"07ebf15048c4004a81db5302","field":"drug.label_event","entity":"application:NDA202811"},{"fact_id":"9927e1b48bd59c95abb9a287","field":"drug.te_code","entity":"application:NDA202811"},{"fact_id":"fc665f47f42263903e25d39d","field":"drug.marketing_status","entity":"application:NDA202811"},{"fact_id":"8c24ee29e08d5284566a3c92","field":"drug.te_code","entity":"application:NDA202811"},{"fact_id":"d88e61962894ce572044380e","field":"drug.marketing_status","entity":"application:NDA202811"},{"fact_id":"499c1d0aec86af6c41efaacc","field":"drug.te_code","entity":"application:NDA202811"},{"fact_id":"2a86068c32257a550cf6a408","field":"drug.marketing_status","entity":"application:NDA202811"},{"fact_id":"7dca799a94dd1bc7bb46a186","field":"ndc.recall","entity":"ndc:00456120330"},{"fact_id":"3dbc0f5b135ffdc585640dae","field":"drug.trial_access","entity":"drug:linaclotide"},{"fact_id":"e01921fefd5ba8ef978c8f57","field":"program.offer","entity":"program:linzess-savings-card"},{"fact_id":"a315bc673487edd8a4a3f823","field":"drug.partd_spending","entity":"drug:linaclotide|linzess"},{"fact_id":"dbc30d2cfb6e2398c8522eac","field":"drug.partd_spending","entity":"drug:linaclotide|linzess"},{"fact_id":"dd1d09ab7470f7f086a9d000","field":"drug.partd_spending","entity":"drug:linaclotide|linzess"},{"fact_id":"e360fba168a4ac34ef5dc33c","field":"drug.partd_spending","entity":"drug:linaclotide|linzess"},{"fact_id":"9f1ee711ac9e8e4eed2209a2","field":"drug.partd_spending","entity":"drug:linaclotide|linzess"},{"fact_id":"fefc9c8ac1f8272a93b50e08","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00456120230:NH"},{"fact_id":"d75c067e818a9f7d706698e3","field":"ndc.medicaid_state_utilization","entity":"ndc_state:00456120330:PR"}],"as_of":{"newest_fact_retrieved_at":"2026-11-10T20:02:39.475Z"},"edition":{"id":"2026-11","merkleRoot":"006ab9a329709cbe7f56a0e1a7c4a02f897655cdfecf9ca34d199690095adcb6","factCount":212100,"manifestPresent":true},"licence":{"classes":["AMBER","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.ratio","reason":"no package has both a brand-class NADAC price and a negotiated price in force"},{"code":"NO_DATA","field":"supply","reason":"no FDA shortage row and no termination date for these packages"},{"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."}