{"answer":{"query":"Dificid","resolved_as":"applications","packages":2,"applications":["NDA201699","NDA213138"],"identity":{"application_numbers":["NDA201699","NDA213138"],"marketing_categories":["NDA"],"labelers":[],"dosage_forms":[{"text":"TABLET, FILM COATED","untrusted":true},{"text":"GRANULE, FOR SUSPENSION","untrusted":true}],"marketing_start":{"earliest":"2011-05-27","latest":"2020-02-18","packages_with_a_start_date":2}},"generic_entry":[{"application":"NDA201699","date":"2028-01-31","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":"7378508*PED","productNo":"001"},"latest_patent_expiry":"2028-01-31","latest_exclusivity_expiry":"2027-01-24","dated_barriers":9,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":4,"exclusivities_listed":1,"fact_id":"7eda21a2a02832aa73f57405"},{"application":"NDA213138","date":"2034-11-28","reading":"upper bound from listed dates, not a forecast","basis":"latest of all listed patent and exclusivity expiries in this Orange Book edition; 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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":"NDA201699","product_no":"001","te_code":"AB","marketing_status":"Prescription","drug_name":{"text":"DIFICID","untrusted":true},"form":{"text":"TABLET;ORAL","untrusted":true},"strength":{"text":"200MG","untrusted":true}},{"application":"NDA213138","product_no":"001","te_code":null,"marketing_status":"Prescription","drug_name":{"text":"DIFICID","untrusted":true},"form":{"text":"FOR SUSPENSION;ORAL","untrusted":true},"strength":{"text":"40MG/ML","untrusted":true}}]},"spending":{"reported_under":{"generic":{"text":"Fidaxomicin","untrusted":true},"brand":{"text":"Dificid","untrusted":true}},"latest_year":2024,"series":[{"year":2020,"gross_spending_usd":47384305.28,"claims":11989,"beneficiaries":8600,"average_spending_per_claim_usd":3952.3150621,"fact_id":"0a77bcab793d6bc6ccfc2550"},{"year":2021,"gross_spending_usd":67952402.38,"claims":16400,"beneficiaries":11968,"average_spending_per_claim_usd":4143.4391695,"fact_id":"81611dcf44d305da9c7b9482"},{"year":2022,"gross_spending_usd":103081746.73,"claims":24035,"beneficiaries":18221,"average_spending_per_claim_usd":4288.8182538,"fact_id":"5885d83ea5c14f195c40baf9"},{"year":2023,"gross_spending_usd":127162102.64,"claims":28662,"beneficiaries":21562,"average_spending_per_claim_usd":4436.6095402,"fact_id":"5dd9d522b19a85407ba29ee1"},{"year":2024,"gross_spending_usd":153755014.43,"claims":34589,"beneficiaries":26020,"average_spending_per_claim_usd":4445.199758,"fact_id":"638dc5fea702b910e1976989"}],"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":"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."}