--- title: "Tonix gets Paragraph IV patent notice from Dr. Reddy's on generic TONMYA" url: "https://aibio.space/news/tonix-gets-paragraph-iv-patent-notice-dr-reddys-generic-tonmya/" publisher: "aibio.space (Biotech Investor Relations News)" date: "2026-10-02" section: "Legal" tickers: "NASDAQ:TNXP" source: "https://www.sec.gov/Archives/edgar/data/1430306/000149315226045603/form8-k.htm" summary: "Dr. Reddy's told Tonix on October 1, 2026 that it filed an ANDA for a generic version of TONMYA 2.8 mg sublingual tablets and certified that four Orange Bo" --- By the aibio.space news desk. Sources - [Tonix Pharmaceuticals Holding Corp. Form 8-K filed October 2, 2026 (SEC EDGAR)](https://www.sec.gov/Archives/edgar/data/1430306/000149315226045603/form8-k.htm) - [Tonix Pharmaceuticals Holding Corp. Form 10-K filed March 12, 2026: business overview and signatures (SEC EDGAR)](https://www.sec.gov/Archives/edgar/data/1430306/000199937126005730/tnxp-10k_123125.htm) [TNXP](https://aibio.space/companies/tonix-pharmaceuticals/) 2026-10-02 # Tonix gets Paragraph IV patent notice from Dr. Reddy's on generic TONMYA application Tickers [TNXP](https://aibio.space/companies/tonix-pharmaceuticals/) Dr. Reddy's told Tonix on October 1, 2026 that it filed an ANDA for a generic version of TONMYA 2.8 mg sublingual tablets and certified that four Orange Book patents are invalid, unenforceable or not infringed. No lawsuit has been filed, and Tonix says it intends to enforce its rights. ## Key facts - **Company**: Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) - **News type**: Legal - **Primary source**: [Tonix Pharmaceuticals Holding Corp. Form 8-K filed October 2, 2026 (SEC EDGAR)](https://www.sec.gov/Archives/edgar/data/1430306/000149315226045603/form8-k.htm) *Stone columns of a government building. Photo: The Building Envelope, CC0, via StockSnap. The picture shows the field, not the companies named.* Tonix Pharmaceuticals Holding Corp. said on October 2, 2026 that a generic drug company has challenged the patents on its drug TONMYA. The company received the notice on October 1, 2026 from Dr. Reddy's Laboratories Ltd. and Dr. Reddy's Laboratories, Inc., which the filing refers to together as DRL. The company reported it in a [Form 8-K](https://www.sec.gov/Archives/edgar/data/1430306/000149315226045603/form8-k.htm) under Item 8.01. ## Who is named, and what is not yet alleged The notice comes from two parties, the two Dr. Reddy's companies, which together the filing calls DRL. The notice states that DRL filed an Abbreviated New Drug Application, or ANDA, with the Food and Drug Administration for a generic version of TONMYA (cyclobenzaprine hydrochloride) sublingual tablets, 2.8 mg. No patent infringement lawsuit has been filed, so the filing names no defendant in litigation and no court or case number. The Paragraph IV certification challenges four Orange Book patents: U.S. Patent Nos. 9636408, 9956188, 10117936 and 10864175. In the applicant's view, the filing says, those patents are invalid, unenforceable or will not be infringed by the generic product. Those are DRL's positions, not findings, and the company has not yet tested them in court. ## How the statute works The 8-K explains the rule that applies. A patent owner may file an infringement suit within 45 days of receiving notice of a Paragraph IV certification. If it does, the Food and Drug Administration is automatically barred from approving the ANDA until the earliest of several events. Those include the end of a 30-month period that begins when the patent owner receives the notice, the expiration of the patents, a settlement or consent decree, or a favorable court decision for the applicant. The 8-K says Tonix intends to vigorously enforce its intellectual property rights for TONMYA against infringement. It also says the company cannot predict the outcome or guarantee the result of any litigation. The filing does not say whether Tonix will sue, or when. ## The product and its dependence The 2025 annual report says TONMYA was approved under the Section 505(b)(2) pathway, based on three Phase 3 studies, two of which showed statistically significant improvement in pain compared with placebo. The company says it is the first new medicine for fibromyalgia in more than 15 years, and that the product launched in November 2025. The same report describes its prospects as highly dependent on TONMYA. It says the company will need additional capital to fund its operations, and that failure to raise it could force it to delay, reduce or eliminate research and development programs and commercialization efforts. Its independent auditor included an explanatory paragraph on the company's ability to continue as a going concern. The report shows revenue of $13.1 million for 2025 against a net loss of $124.0 million, and $99.8 million used in operations. Besides TONMYA, Tonix markets two migraine products, Zembrace SymTouch and Tosymra. The 8-K does not say how a generic entry would affect TONMYA sales. ## What comes next The next date in the process depends on whether Tonix files suit within the 45-day window that the statute provides. If it does, the stay on FDA approval of DRL's ANDA can run up to 30 months. If it does not, the 8-K gives no other timetable. It lists the outcome of any patent litigation, the possibility that the patents are found invalid, unenforceable or not infringed, and generic competition among its risks. Chief Financial Officer Bradley Saenger signed the 8-K. [Report an error](https://aibio.space/reputation/#correction) ## Companies in this story TNXP Tonix Pharmaceuticals Holding Corp. 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Cite as: aibio.space, "Tonix gets Paragraph IV patent notice from Dr. Reddy's on generic TONMYA", 2026-10-02, https://aibio.space/news/tonix-gets-paragraph-iv-patent-notice-dr-reddys-generic-tonmya/