---
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"
generated_at: "2026-10-12T14:41:40.689126+00:00"
event_type: "litigation"
sentiment: "negative"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# Tonix gets Paragraph IV notice from Dr. Reddy's on generic TONMYA; four Orange Book patents challenged

## Summary
- 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.

## SEC filing metadata
- 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
- event_type: litigation
- sentiment: negative
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 8.01
- 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

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-26-045603
- JSON: https://secwatch.observer/filing/0001493152-26-045603.json
- Plain text: https://secwatch.observer/filing/0001493152-26-045603.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.