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ARS Pharmaceuticals, Inc. (NASDAQ:SPRY), a pharmaceutical company with a market capitalization of $1.33 billion and strong financial health according to InvestingPro analysis, reported that on August 13, 2025, it received a Paragraph IV certification notice from Lupin Inc. The notice informs ARS Pharmaceuticals that Lupin has submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA), seeking approval to manufacture and sell a generic version of neffy 2 mg (epinephrine nasal spray) before the expiration of several ARS Pharmaceuticals patents.
According to the company’s statement in a press release, Lupin’s notice alleges that the listed U.S. patents covering neffy are invalid, unenforceable, and/or will not be infringed by the production or sale of Lupin’s proposed generic product. The patents in question include U.S. Patent Nos. 10,576,156; 10,682,414; 11,173,209; 11,191,838; 11,717,571; 11,744,895; 11,918,655; and 12,324,838, all of which are listed in the FDA’s Orange Book.
ARS Pharmaceuticals stated that, as of the date of the filing, it is not aware of any other companies that have submitted similar ANDA filings for neffy.
Under the Drug Price Competition and Patent Term Restoration Act, after receiving a valid Paragraph IV notice, ARS Pharmaceuticals may file a patent infringement lawsuit against Lupin within 45 days. If such a lawsuit is filed in that timeframe, the FDA is prevented from granting final approval to Lupin’s ANDA for up to 30 months or until a court decision is reached, whichever comes first.
ARS Pharmaceuticals indicated its intent to file a patent infringement suit against Lupin, seeking remedies including a permanent injunction to prevent the marketing of a generic version of neffy before the expiration of its patents.
The company noted that there can be no assurance as to the outcome of the ANDA process or the litigation. This information is based on a press release statement disclosed in a recent SEC filing. Despite generating $112.34 million in revenue over the last twelve months, the stock has experienced a 9.62% decline in the past week. For deeper insights into ARS Pharmaceuticals’ financial health and detailed analysis, investors can access comprehensive research reports and additional metrics through InvestingPro, which covers over 1,400 US stocks with expert analysis and actionable intelligence.
In other recent news, ARS Pharmaceuticals reported its second-quarter 2025 earnings, revealing revenue of $15.7 million, which surpassed analyst forecasts of $13.77 million by 14.16%. The earnings per share (EPS) matched expectations at -$0.46. The company achieved net sales of $12.8 million for its neffy product, with approximately 35,000 neffy 2-packs sold during the quarter. Management highlighted that neffy has achieved 93% commercial coverage, with 57% of coverage requiring no prior authorization. Raymond James has maintained a Strong Buy rating on ARS Pharmaceuticals, setting a price target of $32.00, following these earnings results. The firm’s analysis reflects confidence in the company’s performance, particularly due to strong neffy sales. These developments indicate the company’s continued growth and market penetration.
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