Tonix Pharmaceuticals Holding Corp.: receives Paragraph IV notice for TONMYA

What happened
On Oct 1, 2026, Tonix Pharmaceuticals Holding Corp. reported that it received a notice from Dr. Reddy’s Laboratories Ltd. and Dr. Reddy’s Laboratories, Inc. stating that DRL filed an Abbreviated New Drug Application (ANDA) containing a Paragraph IV patent certification with the U.S. Food and Drug Administration for a generic version of TONMYA (cyclobenzaprine hydrochloride) sublingual tablets, 2.8 mg. The notice identifies a Paragraph IV certification as to U.S. Patent Nos. 9636408, 9956188, 10117936 and 10864175 listed in the FDA’s Orange Book. The filing states the company intends to vigorously enforce its intellectual property rights but cannot predict the outcome of any litigation.

Key details

• Date received: Oct 1, 2026.
• ANDA applicant: Dr. Reddy’s Laboratories Ltd. and Dr. Reddy’s Laboratories, Inc.
• Product: TONMYA sublingual tablets, 2.8 mg (cyclobenzaprine hydrochloride).
• Patents listed: U.S. Patent Nos. 9636408, 9956188, 10117936 and 10864175.
• Timing rules cited: a patent infringement lawsuit filed within 45 days of the notice can trigger an automatic stay of FDA approval for up to a 30-month period beginning on the receipt of the notice, subject to court order or earlier resolution.

Why it may matter
This is Item 8.01 (Other events) reporting the receipt of a Paragraph IV notice for TONMYA and the related patent numbers and regulatory timing. The filing also includes forward-looking statements about the company’s intent to enforce its patents and cautions about risks and uncertainties. A filing does not show why the insider traded or why the company acted.