{"schema_version":"secwatch.filing_event.v1","accession":"0001493152-26-045603","form_type":"8-K","ticker":"TNXP","cik":"0001430306","company_name":"Tonix Pharmaceuticals Holding Corp.","filed_at":"2026-10-02T21:20:11+00:00","discovered_at":"2026-10-02T21:22:00.300105+00:00","generated_at":"2026-10-12T14:41:40.689126+00:00","sec_items":["8.01"],"event_type":"litigation","sentiment":"negative","materiality_score":0.6,"calibrated_materiality_score":0.6,"confidence":"high","headline":"Tonix gets Paragraph IV notice from Dr. Reddy's on generic TONMYA; four Orange Book patents challenged","bullets":["Dr. Reddy's filed an ANDA with a Paragraph IV certification for a generic of TONMYA (cyclobenzaprine HCl) sublingual tablets, 2.8 mg; notice received October 1, 2026.","Certification targets four Orange Book-listed Tonix patents: U.S. Patent Nos. 9636408, 9956188, 10117936 and 10864175.","Tonix says it intends to vigorously enforce its TONMYA intellectual property against infringement but cannot predict the outcome.","Suing within 45 days of the notice would bar FDA approval of the ANDA for up to 30 months, or until patent expiry, settlement, or a decision favoring Dr. Reddy's.","Tonix states TONMYA is protected by four patents, all listed in the Orange Book; generic competition timing remains uncertain."],"urls":{"canonical":"https://secwatch.observer/filing/0001493152-26-045603","json":"https://secwatch.observer/filing/0001493152-26-045603.json","markdown":"https://secwatch.observer/filing/0001493152-26-045603.md","text":"https://secwatch.observer/filing/0001493152-26-045603.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1430306/000149315226045603/0001493152-26-045603-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1430306/000149315226045603/form8-k.htm"},"model":{"generated_by":"deepseek-v4.1-flash:cloud@v2","generated_at":"2026-10-12T14:41:40.689126+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"}