ARS Pharmaceuticals Down 9% as Lupin Files Generic Neffy Application

ARS Pharmaceuticals' stock dropped 9% on Friday after Lupin filed an application with the US FDA for a generic version of neffy, an epinephrine nasal spray. This could potentially impact ARS' sales, but the company's SEC filing noted that Lupin's application is subject to review and approval by the FDA. The filing also stated that Lupin is not a customer of ARS.

ARS Pharmaceuticals' (SPRY) stock experienced a significant decline of approximately 9% on Friday, following the news that Indian drugmaker Lupin has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for a generic version of neffy, an epinephrine nasal spray. The filing, which challenges several patents covering neffy, could potentially impact ARS' sales and market position.

Lupin's ANDA challenges the validity of patents, including one covering the composition of matter, which is not set to expire until February 2039. ARS launched neffy in the U.S. in September 2024 and reported U.S. sales of $12.8 million in Q2 of this year. In response to the filing, ARS 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, seeking a permanent injunction to prevent Lupin from introducing a generic version of neffy.

The filing also noted that Lupin is not a customer of ARS, indicating that the potential generic competition is not coming from within ARS' existing business relationships. ARS' Q2 2025 earnings call transcript highlighted the company's high-risk, high-reward strategy with neffy, which has seen an 180% prescription surge and global expansion targets.

While the ANDA process involves review and approval by the FDA, the filing of the application itself suggests that Lupin is confident in its ability to challenge the patents and potentially enter the market with a generic version of neffy. This could pose a significant threat to ARS' market share and sales, particularly given the high stakes involved in the epinephrine nasal spray market.

Investors should closely monitor the ongoing legal battle and the FDA's review process to assess the potential impact on ARS' financial performance. The company's ability to defend its intellectual property rights and maintain market exclusivity will be crucial in determining its future growth prospects.

References:
[1] https://seekingalpha.com/news/4490535-ard-pharma-drops-9-lupin-files-application-generic-neffy