Tonix says Dr. Reddy’s files generic TONMYA challenge with Paragraph IV patent notice
TNXP•Tonix received a Paragraph IV notice from Dr. Reddy’s for a proposed generic version of TONMYA 2.8 mg, setting up potential patent litigation. A suit filed within 45 days could trigger an automatic FDA approval stay for up to 30 months.
1. Patent challenge
Tonix said it received a Paragraph IV notice from Dr. Reddy’s for a proposed generic version of TONMYA 2.8 mg. The filing could lead to patent litigation involving TONMYA patents listed in the Orange Book; Tonix plans to enforce its intellectual property rights but gave no timeline for a lawsuit.
