Tonix receives Paragraph IV notice from Dr. Reddy's on generic TONMYA ANDA filing
On October 1, 2026, Tonix Pharmaceuticals received notice that Dr. Reddy's Laboratories had filed an ANDA with the FDA for a generic version of TONMYA, challenging four Orange Book patents. The filing matters to shareholders because it signals possible generic competition for TONMYA, and the company says it intends to vigorously enforce its intellectual property rights but cannot predict the outcome.
Key points
- Notice received October 1, 2026 from Dr. Reddy's Laboratories Ltd. and Dr. Reddy's Laboratories, Inc.
- ANDA covers a generic version of TONMYA (cyclobenzaprine hydrochloride) sublingual tablets, 2.8 mg, with a Paragraph IV certification
- Certification targets U.S. Patent Nos. 9636408, 9956188, 10117936 and 10864175, all listed in the Orange Book
- A patent infringement suit filed within 45 days of the notice would automatically block FDA approval of the ANDA for up to 30 months, subject to the outcome of litigation
The filing
Written by AI on Nov 9, 2026, 10:08 AM ET, from this filing only. Written later: this filing was briefed after the fact, when past filings were added to the site, so the brief may be read with hindsight; the filing itself is the record of what was known on October 02, 2026.
Briefs are written by AI from the filing text and can contain mistakes — open the filing before acting on anything. Impact (1-5) and tone are the AI's reading of the filing for shareholders, not a price forecast. Not investment advice.