Tonix Pharmaceuticals Holding Corp. received a notice on October 1, 2026, from Dr. Reddy’s Laboratories Ltd. and Dr. Reddy’s Laboratories, Inc., stating that the latter entities filed an Abbreviated New Drug Application with the U.S. Food and Drug Administration for a generic version of TONMYA. The application includes a Paragraph IV patent certification challenging four specific patents listed in the FDA’s Orange Book for the company’s cyclobenzaprine hydrochloride sublingual tablets.
The notice identifies U.S. Patent Nos. 9636408, 9956188, 10117936, and 10864175 as the intellectual property at issue. Under this certification, Dr. Reddy’s asserts that these patents are invalid, unenforceable, or will not be infringed by the manufacture, use, or sale of the proposed generic product. Tonix Pharmaceuticals Holding Corp., based in Berkeley Heights, New Jersey, confirmed that TONMYA is protected by these four patents.
The company stated its intention to vigorously enforce its intellectual property rights against the alleged infringement. However, Tonix noted that it cannot predict the outcome of this matter or guarantee the result of any potential litigation. The filing triggers specific provisions under the Federal Food, Drug, and Cosmetic Act and FDA regulations regarding patent challenges.
If Tonix Pharmaceuticals Holding Corp. files a patent infringement lawsuit within 45 days of receiving the notice, FDA approval of the generic application is automatically stayed. This stay continues until the earliest of several events occurs: the expiration of a 30-month period starting from the receipt of the notice, the expiration of the patents in question, the entry of a settlement order stating the patents are invalid or not infringed, a court decision favorable to the generic applicant, or a different period ordered by the court.
The company’s Chief Financial Officer, Bradley Saenger, signed the Form 8-K report on October 2, 2026. The filing includes forward-looking statements regarding the review of the notice, the timing and outcome of patent litigation, and the potential impact of generic competition on TONMYA sales. Tonix Pharmaceuticals Holding Corp. cautioned investors not to place undue reliance on these statements, which are subject to risks including the possibility that its patents may be found invalid or that the FDA may approve competing applications.