Tonix Pharmaceuticals Holding Corp. received notice that Dr. Reddy’s Laboratories Ltd. filed an Abbreviated New Drug Application (ANDA) with a Paragraph IV patent certification for a generic version of TONMYA (cyclobenzaprine hydrochloride) sublingual tablets, 2.8 mg. The filing challenges four U.S. patents listed in the FDA Orange Book. Under federal law, this triggers a potential 30-month stay on FDA approval of the generic application if Tonix initiates patent infringement litigation within 45 days. Tonix intends to vigorously enforce its intellectual property rights but cannot predict the outcome of any resulting litigation or guarantee the validity of its patents. The company operates in the pharmaceutical industry, developing and commercializing treatments for central nervous system disorders.
