Tonix receives Paragraph IV challenge against TONMYA patents from Dr. Reddy's

Tonix Pharmaceuticals Holding Corp. said in an 8-K filing that on October 1, 2026, it received notice from Dr. Reddy's Laboratories Ltd. and Dr. Reddy's Laboratories, Inc. that the companies had filed an Abbreviated New Drug Application containing a Paragraph IV patent certification with the FDA for a generic version of Tonix's drug, TONMYA (cyclobenzaprine hydrochloride) sublingual tablets, 2.8 mg.¹

The certification applies to four patents. According to the filing, the Paragraph IV patent certification was made with respect to U.S. Patent Nos. 9636408, 9956188, 10117936 and 10864175, which are listed in the FDA's Orange Book of Approved Drug Products with Therapeutic Equivalence Evaluations.¹ Tonix explained that such a certification reflects the generic applicant's position that the listed patent for a branded product is invalid, unenforceable, or would not be infringed by the manufacture, use, or sale of the generic version.¹

Under the regulatory framework described in the filing, if Tonix files a patent infringement lawsuit within 45 days of receiving the notice, FDA approval of the ANDA would automatically be blocked until the earliest of several triggers: expiration of a 30-month period from the notice date, expiration of the patents themselves, a settlement or consent decree finding no infringement or invalidity, a court ruling favorable to the generic applicant, or another period set by the court.¹

Tonix stated that it plans to defend its patent rights covering TONMYA, while acknowledging that it cannot forecast how the matter will resolve. The company noted that TONMYA is covered by four patents, all listed in the Orange Book.¹ The filing was signed by Chief Financial Officer Bradley Saenger on October 2, 2026.