Tonix Pharmaceuticals Holding Corp. filed a complaint for patent infringement against Dr. Reddy's Laboratories in the U.S. District Court for the District of New Jersey on November 13, 2026, following Dr. Reddy's submission of an ANDA for a generic version of TONMYA.

Key Highlights

  • Complaint filed: Tonix filed a patent infringement complaint against Dr. Reddy's Laboratories Ltd. and Dr. Reddy's Laboratories, Inc. on November 13, 2026, in the District of New Jersey.
  • ANDA trigger: Dr. Reddy's filed an Abbreviated New Drug Application with a Paragraph IV patent certification for a generic version of TONMYA (cyclobenzaprine hydrochloride) sublingual tablets, 2.8 mg.
  • Patents at issue: The Paragraph IV certification covers U.S. Patent Nos. 9,636,408, 9,956,188, 10,117,936, and 10,864,175, all listed in the FDA's Orange Book.
  • Statutory stay: According to the filing, the timely filing of the complaint "triggers a statutory stay of final FDA approval of DRL's ANDA for up to 30 months, subject to applicable exceptions and court orders."
  • Relief sought: The complaint seeks an order that the effective date of FDA approval of the ANDA shall be no earlier than the expiration of the last to expire of the asserted patents.
  • Prior notice: Tonix previously disclosed receipt of Dr. Reddy's notice on October 1, 2026, as stated in the filing.

Tonix's Patent Infringement Action Against Dr. Reddy's Over TONMYA ANDA

According to the Form 8-K filed by Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP) on November 13, 2026, the company initiated legal action against Dr. Reddy's Laboratories Ltd. and Dr. Reddy's Laboratories, Inc. (collectively, "DRL") in the U.S. District Court for the District of New Jersey. The complaint alleges that DRL's filing of an Abbreviated New Drug Application for a generic version of TONMYA constitutes infringement of certain Orange Book-listed patents held by Tonix.

The filing states that Tonix had previously received notice from DRL on October 1, 2026, that DRL had submitted an ANDA containing a Paragraph IV patent certification to the FDA. That certification, the filing explains, represents DRL's assertion "that the patent listed in the Orange Book for a branded product is invalid, unenforceable, or will not be infringed by the manufacture, use or sale of the generic product." The four patents cited in DRL's certification are U.S. Patent Nos. 9,636,408, 9,956,188, 10,117,936, and 10,864,175.

The filing notes that the timely filing of the complaint triggers a statutory stay of up to 30 months on final FDA approval of DRL's ANDA, subject to applicable exceptions and court orders. The company's forward-looking statements in the filing, which are the company's own and subject to its cautionary language, address the anticipated timing and outcome of the litigation, the potential for patents to be found invalid or not infringed, and the possible impact of generic competition on TONMYA sales.

What Was Disclosed

Tonix Pharmaceuticals disclosed the filing of a patent infringement complaint against Dr. Reddy's Laboratories in connection with an ANDA for a generic of TONMYA, and noted that the action triggers a statutory stay of FDA approval of the ANDA for up to 30 months.