{"schema_version":"secwatch.filing_event.v1","accession":"0001493152-23-046142","form_type":"8-K","ticker":"ELTP","cik":"0001053369","company_name":"ELITE PHARMACEUTICALS INC /NV/","filed_at":"2023-12-26T23:59:59+00:00","discovered_at":"2026-05-14T18:03:28.050980+00:00","generated_at":"2026-06-07T07:12:06.968430+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"neutral","materiality_score":0.55,"calibrated_materiality_score":0.55,"confidence":"high","headline":"Elite Pharmaceuticals files ANDA for generic CNS stimulant; market $5.1B","bullets":["ANDA accepted for review by FDA on Dec 21, 2023 for undisclosed generic CNS stimulant.","IQVIA reports annual brand and generic market sales of $5.1B for this product (12 months to June 2023).","Elite operates a cGMP and DEA-registered facility in Northvale, NJ for R&D and manufacturing.","No launch timeline or revenue guidance provided; approval and commercialization still pending."],"urls":{"canonical":"https://secwatch.observer/filing/0001493152-23-046142","json":"https://secwatch.observer/filing/0001493152-23-046142.json","markdown":"https://secwatch.observer/filing/0001493152-23-046142.md","text":"https://secwatch.observer/filing/0001493152-23-046142.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1053369/000149315223046142/0001493152-23-046142-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1053369/000149315223046142/form8-k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-07T07:12:06.968430+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}