Tonix Sues Dr. Reddy’s Over TONMYA, Citing Approval Delay of Up to 30 Months
Key Facts
Tonix Pharmaceuticals filed a patent infringement lawsuit on November 13, 2026, against Dr. Reddy’s Laboratories entities in the U.S. District Court for the District of New Jersey over an application to produce a generic version of TONMYA. Tonix said in a filing with the U.S. Securities and Exchange Commission that the application concerns 2.8 mg cyclobenzaprine hydrochloride sublingual tablets. According to the complaint, the company is seeking an order making the effective date of U.S. Food and Drug Administration approval of the application no earlier than the expiration of the last patent asserted. Tonix says the filing infringed patents listed for the treatment in the U.S. Orange Book. The lawsuit puts the product’s exclusivity to a legal test as TONMYA has become an important source of revenue for the company, but the complaint does not establish infringement or determine when a generic competitor may enter the market.
Dr. Reddy’s application includes a Paragraph IV certification, a mechanism that allows a generic drug applicant to state that, in its view, a listed product patent is invalid or unenforceable, or that making, using and selling the generic product would not infringe it. Tonix’s filing explained that the certification represents the applicant’s position and is not a court ruling on patent validity or whether infringement occurred. Tonix says the complaint is based on certain patents listed in the Orange Book and seeks to delay the approval’s effective date until after the last of those patents expires. The filing does not say that a ruling on the merits has been issued or that the court has accepted the company’s allegations. The legal dispute therefore concerns the validity of the protection and its applicability to the proposed product, while the generic approval application remains in the regulatory and judicial process.
Tonix said that filing the complaint on time triggers a statutory stay of final FDA approval of Dr. Reddy’s application for up to 30 months, subject to applicable exceptions and court orders. The period does not mean the application has been permanently denied, and its maximum duration is subject to any exceptions or judicial decisions. Tonix previously received notice of Dr. Reddy’s certification on October 1, 2026, and said in its quarterly filing on November 9 that it intended to begin litigation within 45 days of receiving the notice. The lawsuit was filed on November 13, within the timeframe announced by the company. The Orange Book lists the expiration date for each of TONMYA’s four patents as March 14, 2034, providing a timeline for Tonix’s request concerning the last patent asserted in the complaint, without determining the outcome of the case.
The commercial stakes are tied to the treatment’s sales. Tonix reported that TONMYA net sales in the third quarter of 2026 were about $15 million, up 37% from the previous quarter. Total prescriptions reached 16,375 in the same quarter, up 28% quarter on quarter. The company attributed broader payer access to two agreements with commercial purchasing groups and two agreements with managed Medicare programs, as well as Medicaid availability in nearly every state. The FDA approved the treatment in August 2025 as the first new prescription drug for fibromyalgia in more than 15 years, and Tonix launched it on November 17, 2025. TONMYA is used to treat fibromyalgia in adults, and its sublingual tablets contain 2.8 mg of cyclobenzaprine hydrochloride.
The company’s financial data showed gross product revenue of $17.234 million in the third quarter of 2026, compared with $3.290 million in the same period of 2025, while TONMYA net product revenue was $15.024 million in the latest quarter. Meanwhile, the net loss widened to $53.3 million from $32.0 million a year earlier. Tonix warned in its quarterly filing that enforcing and defending patents can be costly and consume management time, and that generic competition could materially harm revenue and results if the patents are found invalid or unenforceable, or if the court concludes that no infringement occurred. It also said its cash resources as of September 30, 2026, together with proceeds from equity offerings raised after that date, are expected to fund operations and capital expenditures through early in the third quarter of 2027, but will not be sufficient for 12 months from the date the financial statements are issued. Tonix shares closed at $3.01 on November 13, while Dr. Reddy’s shares closed at $14.74 in the same session.