{"answer":{"query":"Acthar","resolved_as":"applications","packages":4,"applications":["NDA008372"],"identity":{"application_numbers":["NDA008372"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"INJECTION","untrusted":true}],"marketing_start":{"earliest":"2013-01-07","latest":"2024-02-29","packages_with_a_start_date":4}},"generic_entry":[{"application":"NDA008372","date":"2041-07-18","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":"11752199","productNo":"008"},"latest_patent_expiry":"2041-07-18","latest_exclusivity_expiry":"NOT_PROVIDED","dated_barriers":3,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":1,"exclusivities_listed":0,"fact_id":"916306f3b86d07ffb5d0c2fe"}],"label_history":{"events_total":32,"non_cmc_events":18,"counts_by_class":{"LABELING":17,"REMS":1},"cmc_events":14,"recent_non_cmc_events":[{"application":"NDA008372","submission_no":88,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2026-10-05","documents":[{"type":"Label","date":"2026-10-06","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/008372s088lbl.pdf","untrusted":true}},{"type":"Letter","date":"2026-10-06","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/008372Orig1s088ltr.pdf","untrusted":true}}],"fact_id":"872330eb97b892f8d280a614"},{"application":"NDA008372","submission_no":74,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2024-02-29","documents":[{"type":"Label","date":"2024-03-01","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/008372s074lbl.pdf","untrusted":true}},{"type":"Letter","date":"2024-03-01","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/008372Orig1s074ltr.pdf","untrusted":true}}],"fact_id":"7d4c5aa5970f56242c00091c"},{"application":"NDA008372","submission_no":71,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2021-10-29","documents":[{"type":"Label","date":"2021-10-29","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/008372s071lbl.pdf","untrusted":true}},{"type":"Letter","date":"2021-11-01","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/008372Orig1s071ltr.pdf","untrusted":true}}],"fact_id":"34010c823c0d898f48f655f7"},{"application":"NDA008372","submission_no":68,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2021-03-02","documents":[{"type":"Letter","date":"2021-03-03","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/008372Orig1s068ltr.pdf","untrusted":true}},{"type":"Label","date":"2021-03-03","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/008372s068lbl.pdf","untrusted":true}}],"fact_id":"ea0c8910b7d655855e5a51c6"},{"application":"NDA008372","submission_no":61,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2019-03-26","documents":[{"type":"Label","date":"2019-03-27","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2019/008372s061lbl.pdf","untrusted":true}},{"type":"Letter","date":"2019-03-27","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/008372Orig1s061ltr.pdf","untrusted":true}}],"fact_id":"9c95537c7b0262ebb9a4ef35"}],"note":"a dated list of FDA supplements and their classes, not a reading of what changed in the label"},"substitution":{"products_total":4,"te_code_counts":{"NOT_PROVIDED":4},"marketing_status_counts":{"Prescription":3,"Discontinued":1},"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":"NDA008372","product_no":"003","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"ACTHAR GEL (AUTOINJECTOR)","untrusted":true},"form":{"text":"INJECTABLE;INJECTION","untrusted":true},"strength":{"text":"40 UNITS/0.5ML","untrusted":true}},{"application":"NDA008372","product_no":"006","te_code":null,"marketing_status":"Discontinued","drug_name":{"text":"ACTHAR GEL","untrusted":true},"form":{"text":"INJECTABLE;INJECTION","untrusted":true},"strength":{"text":"40 UNITS/ML","untrusted":true}},{"application":"NDA008372","product_no":"004","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"ACTHAR GEL (AUTOINJECTOR)","untrusted":true},"form":{"text":"INJECTABLE;INJECTION","untrusted":true},"strength":{"text":"80 UNITS/ML","untrusted":true}},{"application":"NDA008372","product_no":"008","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"ACTHAR GEL","untrusted":true},"form":{"text":"INJECTABLE;INJECTION","untrusted":true},"strength":{"text":"80 UNITS/ML","untrusted":true}}]},"recalls":{"recalls_total":2,"counts_by_class":{"Class II":2},"packages_of_these_applications":4,"most_recent":[{"recall_number":"D-0803-2026","classification":"Class II","status":"Ongoing","report_date":"2026-09-02","recall_initiated":"2026-08-06","recalling_firm":{"text":"Mallinckrodt Hospital Products Inc.","untrusted":true},"reason":{"text":"Presence of particulate matter: glass and stopper piece","untrusted":true},"packages_named":2,"fact_id":"e2d6b25c0f40f465d2882c54"},{"recall_number":"D-0340-2024","classification":"Class II","status":"Ongoing","report_date":"2024-02-28","recall_initiated":"2024-02-06","recalling_firm":{"text":"Mallinckrodt Hospital Products Inc.","untrusted":true},"reason":{"text":"cGMP deviations: Temperature excursion due to shipping delay from manufacturer to distributor. Affected distributor has been notified.","untrusted":true},"packages_named":1,"fact_id":"8265a016b3c53259dbe9c18f"}],"meaning":"FDA classifies the health hazard of a recall, not its effect on supply"},"spending":{"reported_under":{"generic":{"text":"Corticotropin","untrusted":true},"brand":{"text":"Acthar","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":621884161.43,"claims":9857,"beneficiaries":1668,"average_spending_per_claim_usd":63090.611893,"fact_id":"0c40e4f811bb8beb6f510200"},{"year":2021,"gross_spending_usd":431097613.87,"claims":6667,"beneficiaries":1158,"average_spending_per_claim_usd":64661.40901,"fact_id":"38e3f3e8c7d614fd5eddb165"},{"year":2022,"gross_spending_usd":400387038.54,"claims":5913,"beneficiaries":1007,"average_spending_per_claim_usd":67713.011761,"fact_id":"eadd6f0ae4e0535535010a22"},{"year":2023,"gross_spending_usd":377839858.86,"claims":5235,"beneficiaries":942,"average_spending_per_claim_usd":72175.713249,"fact_id":"c5308087d4c5ff0fc14942c7"},{"year":2024,"gross_spending_usd":360057228.49,"claims":4926,"beneficiaries":836,"average_spending_per_claim_usd":73093.225434,"fact_id":"58196ffeaae193dbf8e09f6b"}],"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}}},"payment_limit":{"codes":[{"hcpcs":"J0801","quarter":"2026Q4","effective":"October 1, 2026 through December 31, 2026","payment_limit_usd":3884.267,"dosage_descriptor":{"text":"40 UNITS","untrusted":true},"packages_matched":3,"read_on":"2026-11-07T07:31:28.000Z","source_url":{"text":"https://www.cms.gov/medicare/payment/part-b-drugs/asp-pricing-files","untrusted":true},"fact_id":"6a5287718fd57eac366fe2b1"}],"codes_total":1,"meaning":"a Medicare Part B payment ceiling for providers billing a HCPCS code, per dosage descriptor unit; not a price a patient pays, and the presence of a code does not indicate that Medicare covers a product"},"rems":{"programs":[{"application":"NDA008372","program":{"text":"H.P. Acthar Gel","untrusted":true},"rems_id":"23","in_force":false,"released":true,"moved_to_shared_system":false,"has_etasu":false,"program_date":"2010-10-15","last_modified":"2012-07-05","source_page":"https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=23","other_programs":0,"read_on":"2026-11-07T20:05:28.959Z","fact_id":"984b7f4b375ef645b2608d7a"}],"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":0,"all_states_medicaid_reimbursed_usd":0,"all_states_medicaid_paid_prescriptions":0,"top_states":[],"unlabelled_state_code_xx":{"medicaid_paid_prescriptions":98,"medicaid_reimbursed_usd":6265250.02,"note":"the source uses the code XX without defining it; it is reported here and never added to a state"},"built_from_facts":1,"facts_fee_for_service_only":1,"older_year_facts_not_used":4,"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":"4eb55bb062922f8c42beb9b0","field":"ndc.listing","entity":"ndc:63004871001"},{"fact_id":"31a5f57dcc0728c4e027d498","field":"ndc.listing","entity":"ndc:63004871002"},{"fact_id":"f7c81a7c09e621ffe83f0196","field":"ndc.listing","entity":"ndc:63004871104"},{"fact_id":"916306f3b86d07ffb5d0c2fe","field":"drug.generic_entry_earliest","entity":"application:NDA008372"},{"fact_id":"2c972047668753712d743d04","field":"drug.patent","entity":"application:NDA008372"},{"fact_id":"872330eb97b892f8d280a614","field":"drug.label_event","entity":"application:NDA008372"},{"fact_id":"7d4c5aa5970f56242c00091c","field":"drug.label_event","entity":"application:NDA008372"},{"fact_id":"34010c823c0d898f48f655f7","field":"drug.label_event","entity":"application:NDA008372"},{"fact_id":"ea0c8910b7d655855e5a51c6","field":"drug.label_event","entity":"application:NDA008372"},{"fact_id":"9c95537c7b0262ebb9a4ef35","field":"drug.label_event","entity":"application:NDA008372"},{"fact_id":"9f01d48e130bc543c7e31f03","field":"drug.marketing_status","entity":"application:NDA008372"},{"fact_id":"60600baaa2b02e1fa64ae938","field":"drug.marketing_status","entity":"application:NDA008372"},{"fact_id":"4e78937495012833de1ced65","field":"drug.marketing_status","entity":"application:NDA008372"},{"fact_id":"42a2232834edadad63c7d000","field":"drug.marketing_status","entity":"application:NDA008372"},{"fact_id":"e2d6b25c0f40f465d2882c54","field":"ndc.recall","entity":"ndc:63004871002"},{"fact_id":"8265a016b3c53259dbe9c18f","field":"ndc.recall","entity":"ndc:63004871001"},{"fact_id":"0c40e4f811bb8beb6f510200","field":"drug.partd_spending","entity":"drug:corticotropin|acthar"},{"fact_id":"38e3f3e8c7d614fd5eddb165","field":"drug.partd_spending","entity":"drug:corticotropin|acthar"},{"fact_id":"eadd6f0ae4e0535535010a22","field":"drug.partd_spending","entity":"drug:corticotropin|acthar"},{"fact_id":"c5308087d4c5ff0fc14942c7","field":"drug.partd_spending","entity":"drug:corticotropin|acthar"},{"fact_id":"58196ffeaae193dbf8e09f6b","field":"drug.partd_spending","entity":"drug:corticotropin|acthar"},{"fact_id":"6a5287718fd57eac366fe2b1","field":"drug.asp_price","entity":"hcpcs:J0801"},{"fact_id":"984b7f4b375ef645b2608d7a","field":"drug.rems","entity":"application:NDA008372"}],"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":"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."}