---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-26-051693"
form_type: "8-K"
ticker: "TNXP"
cik: "0001430306"
company_name: "Tonix Pharmaceuticals Holding Corp."
filed_at: "2026-11-13T21:00:39+00:00"
generated_at: "2026-11-13T21:02:25.408766+00:00"
event_type: "litigation"
sentiment: "negative"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# Tonix sues Dr. Reddy's over TONMYA generic; ANDA filing triggers up to 30-month FDA approval stay

## Summary
- Dr. Reddy's sent an Oct. 1, 2026 notice that it filed an ANDA with a Paragraph IV certification for generic TONMYA (cyclobenzaprine HCl) sublingual tablets, 2.8 mg.
- Tonix filed a patent infringement complaint Nov. 13, 2026 in the U.S. District Court for the District of New Jersey against Dr. Reddy's Laboratories Ltd. and Dr. Reddy's Laboratories, Inc.
- Complaint asserts Orange Book patents 9,636,408; 9,956,188; 10,117,936; and 10,864,175, and seeks FDA approval no earlier than the last patent's expiration.
- Timely filing triggers a statutory stay of final FDA approval of Dr. Reddy's ANDA for up to 30 months, subject to exceptions and court orders.
- Tonix cautions that its patents could be found invalid, unenforceable or not infringed, and generic competition could hurt TONMYA sales.

## SEC filing metadata
- accession: 0001493152-26-051693
- form_type: 8-K
- ticker: TNXP
- cik: 0001430306
- company_name: Tonix Pharmaceuticals Holding Corp.
- filed_at: 2026-11-13T21:00:39+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/1430306/000149315226051693/0001493152-26-051693-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1430306/000149315226051693/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-26-051693
- JSON: https://secwatch.observer/filing/0001493152-26-051693.json
- Plain text: https://secwatch.observer/filing/0001493152-26-051693.txt

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