Tharimmune (Nasdaq:THAR) has secured significant global patent protection for TH-104, its novel transmucosal film technology, extending coverage until at least 2040. The patents, granted in Japan, Mexico, Australia, and the United States, cover a unique method for administering nalmefene via a single-layer, mucoadhesive film.
The FDA has provided positive feedback on TH-104's NDA pathway, confirming that a 505(b)(2) submission is viable for preventing respiratory and CNS distress, with no additional clinical trials required for military and first responder use against weaponized opioids. The drug features a longer half-life compared to existing alternatives like Narcan®, potentially providing sustained protection in high-risk environments.
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