August 13, 2025 — Leads & Copy — Tharimmune, Inc. (Nasdaq:THAR) has announced a significant expansion of its intellectual property portfolio for TH-104, its novel transmucosal film.
The new patents, recently granted and allowed across key global markets, will enable the company’s long-term strategy of pursuing broader indications for the technology, beginning with its lead program as a critical medical countermeasure for military and first responders against high-potency opioids.
The announcement follows recent positive feedback from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) pathway for TH-104. The FDA confirmed that a 505(b)(2) NDA submission for the prevention of respiratory and/or central nervous system distress is a viable path, and no additional clinical trials seem to be required for this specific indication for use in military personnel and/or first responders who may be exposed to weaponized high-potency opioids, such as fentanyl or its analogues.
The recent granting and allowance of patents in Japan, Mexico, Australia, and the United States further strengthen the company’s intellectual property position, providing protection for TH-104 out to at least 2040 in key markets.
TH-104 is a buccal film formulation of nalmefene, an opioid antagonist with a significantly longer half-life compared to existing options. “The recent patent grants are important for our TH-104 platform,” said Sireesh Appajosyula, CEO of Tharimmune.
The newly granted and allowed patents specifically cover a novel method and device for transmucosal administration of nalmefene via a single-layer, self-supporting, mucoadhesive film with distinct domains for optimized drug delivery and pH balance.
Contact: ir@tharimmune.com
