{"answer":{"query":"Sprycel","resolved_as":"applications","packages":12,"applications":["NDA021986"],"identity":{"application_numbers":["NDA021986"],"marketing_categories":["NDA","NDA AUTHORIZED GENERIC"],"labelers":[],"dosage_forms":[{"text":"TABLET","untrusted":true}],"marketing_start":{"earliest":"2006-06-27","latest":"2024-09-03","packages_with_a_start_date":12}},"generic_entry":[{"application":"NDA021986","date":"2026-09-28","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":"7491725*PED","productNo":"005"},"latest_patent_expiry":"2026-09-28","latest_exclusivity_expiry":"2026-06-21","dated_barriers":24,"undated_barriers":0,"orange_book_edition":"2026-09","patents_listed":1,"exclusivities_listed":2,"fact_id":"16a6bf09b3c5ac92a255bd20"}],"label_history":{"events_total":23,"non_cmc_events":21,"counts_by_class":{"LABELING":12,"EFFICACY":9},"cmc_events":2,"recent_non_cmc_events":[{"application":"NDA021986","submission_no":29,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2026-10-16","documents":[{"type":"Label","date":"2026-10-20","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/021986s029lbl.pdf","untrusted":true}},{"type":"Letter","date":"2026-10-21","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/021986Orig1s029ltr.pdf","untrusted":true}}],"fact_id":"be0e390456d5a8e625a9a6a5"},{"application":"NDA021986","submission_no":28,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2024-07-31","documents":[{"type":"Letter","date":"2024-08-02","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021986Orig1s028ltr.pdf","untrusted":true}},{"type":"Label","date":"2024-08-02","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021986s028lbl.pdf","untrusted":true}}],"fact_id":"c25ba099f585dc5899c97a91"},{"application":"NDA021986","submission_no":27,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2023-02-08","documents":[{"type":"Letter","date":"2023-02-09","link":{"text":"https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021986Orig1s027ltr.pdf","untrusted":true}},{"type":"Label","date":"2023-02-09","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021986s027lbl.pdf","untrusted":true}}],"fact_id":"651f988aaf384d353fd9ae85"},{"application":"NDA021986","submission_no":25,"class_code":"LABELING","class_description":{"text":"Labeling","untrusted":true},"status":"AP","date":"2021-06-29","documents":[{"type":"Letter","date":"2021-06-30","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021986Orig1s025ltr.pdf","untrusted":true}},{"type":"Label","date":"2021-06-30","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021986s025lbl.pdf","untrusted":true}}],"fact_id":"de3c4487f7d7b90a2e3988fa"},{"application":"NDA021986","submission_no":21,"class_code":"EFFICACY","class_description":{"text":"Efficacy","untrusted":true},"status":"AP","date":"2018-12-21","documents":[{"type":"Label","date":"2018-12-26","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021986s021lbl.pdf","untrusted":true}},{"type":"Letter","date":"2018-12-30","link":{"text":"http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021986Orig1s021Ltr.pdf","untrusted":true}}],"fact_id":"add249d0cd20cfcedd494a1e"}],"note":"a dated list of FDA supplements and their classes, not a reading of what changed in the label"},"substitution":{"products_total":6,"te_code_counts":{"AB":6},"marketing_status_counts":{"Prescription":6},"meaning":"raw FDA codes; 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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":"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":"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."}