litigation
confidence high
sentiment negative
materiality 0.60
Tonix gets Paragraph IV notice from Dr. Reddy's on generic TONMYA; four Orange Book patents challenged
Tonix Pharmaceuticals Holding Corp.
- Dr. Reddy's filed an ANDA with a Paragraph IV certification for a generic of TONMYA (cyclobenzaprine HCl) sublingual tablets, 2.8 mg; notice received October 1, 2026.
- Certification targets four Orange Book-listed Tonix patents: U.S. Patent Nos. 9636408, 9956188, 10117936 and 10864175.
- Tonix says it intends to vigorously enforce its TONMYA intellectual property against infringement but cannot predict the outcome.
- Suing within 45 days of the notice would bar FDA approval of the ANDA for up to 30 months, or until patent expiry, settlement, or a decision favoring Dr. Reddy's.
- Tonix states TONMYA is protected by four patents, all listed in the Orange Book; generic competition timing remains uncertain.