NewsMeter
Tonix Pharmaceuticals Holding Corp. received a notice on October 1, 2026, from 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.
9636408, 9956188, 10117936, and 10864175 as the intellectual property at issue.
Keep reading