Tonix's lawsuit can delay final FDA approval of DRL's generic TONMYA for up to 30 months, giving its branded drug more protection. DRL's patent challenge and the risks and costs of the case remain.
The delay gives Tonix more time to sell TONMYA before DRL could receive final approval for a generic version. It does not settle whether Tonix's patents will stand. The company also faces legal costs and time demands.
Dr. Reddy's generic application now faces a possible delay of up to 30 months as Tonix's patent case proceeds. The lawsuit could postpone its chance to sell a generic TONMYA.
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