On August 13, 2025, ARS Pharmaceuticals Inc. announced that it received a Paragraph IV certification notice from Lupin Inc. 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 ARS Pharmaceuticals' product, neffy©2 mg (epinephrine nasal spray), before the expiration of several U.S. patents. The patents in question are listed in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book. ARS Pharmaceuticals plans to vigorously defend its intellectual property rights and intends to file a patent infringement lawsuit against Lupin.
Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. ARS Pharmaceuticals Inc. published the original content used to generate this news brief via EDGAR, the Electronic Data Gathering, Analysis, and Retrieval system operated by the U.S. Securities and Exchange Commission (Ref. ID: 0001193125-25-190202), on August 28, 2025, and is solely responsible for the information contained therein.