ARS Pharmaceuticals experienced a significant 9% stock decline on Friday following news that Indian pharmaceutical company Lupin has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration for a generic version of neffy, the company's epinephrine nasal spray. The filing represents a direct challenge to ARS's market position in the critical epinephrine delivery market.
Patent Challenge Targets Key Intellectual Property
Lupin's ANDA filing challenges the validity of several patents covering neffy, including a composition of matter patent that is not scheduled to expire until February 2039. This aggressive patent challenge strategy suggests Lupin's confidence in its ability to successfully contest ARS's intellectual property protections and potentially enter the market with a competing generic product.
The timing of the challenge is particularly significant given neffy's recent commercial launch. ARS launched neffy in the U.S. market in September 2024 and reported U.S. sales of $12.8 million in the second quarter of this year, demonstrating early commercial traction for the innovative nasal spray delivery system.
ARS Responds with Legal Defense Strategy
In response to Lupin's filing, ARS Pharmaceuticals stated in an SEC filing that it intends to "vigorously defend its intellectual property rights" and will promptly file a patent infringement suit against Lupin. The company is seeking a permanent injunction to prevent Lupin from introducing a generic version of neffy to the market.
The SEC filing also clarified that Lupin is not a customer of ARS, indicating that the potential generic competition is emerging from outside ARS's existing business relationships rather than from within its established partner network.
Market Performance and Growth Trajectory
Despite the patent challenge, neffy has demonstrated strong early market performance. According to ARS's Q2 2025 earnings call transcript, the company has implemented a "high-risk, high-reward strategy" with neffy, which has resulted in a 180% prescription surge and established global expansion targets.
The ANDA process requires comprehensive review and approval by the FDA, though the filing itself signals Lupin's strategic intent to compete in the epinephrine nasal spray market. This development could pose a significant threat to ARS's market share and sales trajectory, particularly given the high stakes involved in the epinephrine delivery market where patients depend on reliable, accessible emergency treatments.
Implications for Market Exclusivity
The patent challenge represents a critical test of ARS's ability to maintain market exclusivity for its innovative delivery system. The company's capacity to successfully defend its intellectual property rights will be crucial in determining future growth prospects and market positioning in the competitive pharmaceutical landscape.
Investors and industry observers will be closely monitoring both the ongoing legal proceedings and the FDA's review process to assess the potential long-term impact on ARS's financial performance and market dominance in the epinephrine nasal spray segment.
