{"answer":{"query":"Pradaxa","resolved_as":"applications","packages":12,"applications":["NDA022512","NDA214358"],"identity":{"application_numbers":["NDA022512","NDA214358"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"CAPSULE","untrusted":true},{"text":"PELLET","untrusted":true}],"marketing_start":{"earliest":"2015-11-23","latest":"2022-03-16","packages_with_a_start_date":12}},"generic_entry":[{"application":"NDA022512","date":"2031-07-20","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":"9034822*PED","productNo":"001"},"latest_patent_expiry":"2031-07-20","latest_exclusivity_expiry":"NOT_PROVIDED","dated_barriers":12,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":2,"exclusivities_listed":0,"fact_id":"7fd33ca59e3ddcba1bda2b31"},{"application":"NDA214358","date":"2026-03-07","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":"7932273*PED","productNo":"005"},"latest_patent_expiry":"2026-03-07","latest_exclusivity_expiry":"NOT_PROVIDED","dated_barriers":12,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":1,"exclusivities_listed":0,"fact_id":"5b463be6d0ca40b28b205a35"}],"label_history":{"events_total":35,"non_cmc_events":28,"counts_by_class":{"LABELING":24,"EFFICACY":3,"REMS":1},"cmc_events":7,"recent_non_cmc_events":[{"application":"NDA022512","submission_no":49,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-06-17","documents":[{"type":"Label","date":"2025-10-03","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2026/022512Orig1s049lbl.pdf","untrusted":true}},{"type":"Letter","date":"2025-10-03","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/022512Orig1s049;214358Orig1s009correctedltr.pdf","untrusted":true}}],"fact_id":"e5b4130debf2db548201ab46"},{"application":"NDA214358","submission_no":9,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2025-06-17","documents":[{"type":"Label","date":"2025-10-03","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2026/214358s009lbl.pdf","untrusted":true}},{"type":"Letter","date":"2025-10-03","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/022512Orig1s049;214358Orig1s009correctedltr.pdf","untrusted":true}}],"fact_id":"e24e7bb40bae9c8faf72fdcb"},{"application":"NDA022512","submission_no":47,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2023-11-17","documents":[{"type":"Letter","date":"2023-11-20","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022512Orig1s047ltr.pdf","untrusted":true}},{"type":"Label","date":"2024-01-12","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022512s047lbl.pdf","untrusted":true}}],"fact_id":"91cdf406774101d01474de53"},{"application":"NDA214358","submission_no":7,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2023-11-14","documents":[{"type":"Letter","date":"2023-11-15","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/214358Orig1s007ltr.pdf","untrusted":true}},{"type":"Label","date":"2023-11-15","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/214358s007lbl.pdf","untrusted":true}}],"fact_id":"f3cf680d32286755afb8d924"},{"application":"NDA214358","submission_no":1,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2022-03-25","documents":[{"type":"Letter","date":"2022-03-28","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/214358Orig1s001ltr.pdf","untrusted":true}},{"type":"Label","date":"2022-04-05","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2022/214358Orig1s001lbl.pdf","untrusted":true}}],"fact_id":"5fe702a0cfb242fb7c016550"}],"note":"a dated list of FDA supplements and their classes, not a reading of what changed in the label"},"substitution":{"products_total":9,"te_code_counts":{"AB":3,"NOT_PROVIDED":6},"marketing_status_counts":{"Prescription":3,"Discontinued":6},"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":"NDA022512","product_no":"003","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"PRADAXA","untrusted":true},"form":{"text":"CAPSULE;ORAL","untrusted":true},"strength":{"text":"EQ 110MG BASE","untrusted":true}},{"application":"NDA022512","product_no":"001","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"PRADAXA","untrusted":true},"form":{"text":"CAPSULE;ORAL","untrusted":true},"strength":{"text":"EQ 75MG BASE","untrusted":true}},{"application":"NDA022512","product_no":"002","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"PRADAXA","untrusted":true},"form":{"text":"CAPSULE;ORAL","untrusted":true},"strength":{"text":"EQ 150MG BASE","untrusted":true}},{"application":"NDA214358","product_no":"003","te_code":null,"marketing_status":"Discontinued","drug_name":{"text":"PRADAXA","untrusted":true},"form":{"text":"PELLETS;ORAL","untrusted":true},"strength":{"text":"EQ 40MG BASE/PACKET","untrusted":true}},{"application":"NDA214358","product_no":"001","te_code":null,"marketing_status":"Discontinued","drug_name":{"text":"PRADAXA","untrusted":true},"form":{"text":"PELLETS;ORAL","untrusted":true},"strength":{"text":"EQ 20MG BASE/PACKET","untrusted":true}},{"application":"NDA214358","product_no":"002","te_code":null,"marketing_status":"Discontinued","drug_name":{"text":"PRADAXA","untrusted":true},"form":{"text":"PELLETS;ORAL","untrusted":true},"strength":{"text":"EQ 30MG BASE/PACKET","untrusted":true}},{"application":"NDA214358","product_no":"006","te_code":null,"marketing_status":"Discontinued","drug_name":{"text":"PRADAXA","untrusted":true},"form":{"text":"PELLETS;ORAL","untrusted":true},"strength":{"text":"EQ 150MG BASE/PACKET","untrusted":true}},{"application":"NDA214358","product_no":"004","te_code":null,"marketing_status":"Discontinued","drug_name":{"text":"PRADAXA","untrusted":true},"form":{"text":"PELLETS;ORAL","untrusted":true},"strength":{"text":"EQ 50MG BASE/PACKET","untrusted":true}},{"application":"NDA214358","product_no":"005","te_code":null,"marketing_status":"Discontinued","drug_name":{"text":"PRADAXA","untrusted":true},"form":{"text":"PELLETS;ORAL","untrusted":true},"strength":{"text":"EQ 110MG BASE/PACKET","untrusted":true}}]},"spending":{"reported_under":{"generic":{"text":"Dabigatran Etexilate Mesylate","untrusted":true},"brand":{"text":"Pradaxa","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":599577174.57,"claims":909807,"beneficiaries":184747,"average_spending_per_claim_usd":659.01578529,"fact_id":"74569f8e4c7f0b0b50e8e74c"},{"year":2021,"gross_spending_usd":571018502.26,"claims":806337,"beneficiaries":177065,"average_spending_per_claim_usd":708.16358701,"fact_id":"c15aa85e027116a1c96a8ff8"},{"year":2022,"gross_spending_usd":469904882.22,"claims":733966,"beneficiaries":172740,"average_spending_per_claim_usd":640.22704351,"fact_id":"a929a9525b32d0eaa2023957"},{"year":2023,"gross_spending_usd":176220136.53,"claims":536887,"beneficiaries":144821,"average_spending_per_claim_usd":328.22574681,"fact_id":"5e74c9f7c0c9dc7c22d2a6ab"},{"year":2024,"gross_spending_usd":123182255.71,"claims":481836,"beneficiaries":139514,"average_spending_per_claim_usd":255.65183114,"fact_id":"e7f0d1d2e988a15414cfabff"}],"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; 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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":"AMBIGUOUS","field":"spending","reason":"2 brand and generic name pairs match; the series shown is the one with the newest year and the largest spending"},{"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."}