Tonix sues Dr. Reddy's over TONMYA generic; ANDA filing triggers up to 30-month FDA approval stay

Tonix Pharmaceuticals Holding Corp.

Dr. Reddy's sent an Oct. 1, 2026 notice that it filed an ANDA with a Paragraph IV certification for generic TONMYA (cyclobenzaprine HCl) sublingual tablets, 2.8 mg.
Tonix filed a patent infringement complaint Nov. 13, 2026 in the U.S. District Court for the District of New Jersey against Dr. Reddy's Laboratories Ltd. and Dr. Reddy's Laboratories, Inc.
Complaint asserts Orange Book patents 9,636,408; 9,956,188; 10,117,936; and 10,864,175, and seeks FDA approval no earlier than the last patent's expiration.
Timely filing triggers a statutory stay of final FDA approval of Dr. Reddy's ANDA for up to 30 months, subject to exceptions and court orders.
Tonix cautions that its patents could be found invalid, unenforceable or not infringed, and generic competition could hurt TONMYA sales.

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