SEC Form 8-K filed by ARS Pharmaceuticals Inc.
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| Item 8.01 | Other Events. |
On August 13, 2025, ARS Pharmaceuticals, Inc. (the “Company”) received a Paragraph IV certification notice (the “Notice”) from Lupin Inc. (“Lupin”), advising that Lupin has submitted to the U.S. Food and Drug Administration (the “FDA”) an Abbreviated New Drug Application (“ANDA”) seeking approval to manufacture and sell a generic version of the Company’s product neffy© 2 mg (epinephrine nasal spray) prior to the expiration of the following U.S. Patent Nos.: 10,576,156, which is a composition of matter patent; 10,682,414, which the Company successfully defended against an Inter Partes Review; 11,173,209; 11,191,838; 11,717,571; 11,744,895; 11,918,655; and 12,324,838 (the “Patents”), all of which are listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (commonly referred to as the Orange Book). The Notice alleges that the Patents are invalid, unenforceable and/or will not be infringed by the commercial manufacture, use or sale of the generic product described in Lupin’s ANDA. As of the date of this filing, the Company is not aware of any other ANDA filers.
Under the Food and Drug Cosmetic Act, as amended by the Drug Price Competition and Patent Term Restoration Act of 1984, as amended, after receipt of a valid Paragraph IV notice, the Company may bring a patent infringement suit against Lupin. If such a suit is commenced within 45 days of receipt of the Notice, this triggers an automatic 30-month stay, which would prevent the FDA from issuing final approval of Lupin’s ANDA until the expiration of the stay.
The Company intends to vigorously defend its intellectual property rights relating to neffy and promptly file a patent infringement suit against Lupin, seeking, among other remedies, a permanent injunction to prevent Lupin from introducing a generic version of neffy that would infringe the Patents.
There can be no assurance as to the ultimate outcome of the ANDA submission and the lawsuit we intend to file against Lupin. Please refer to the risks and uncertainties described under the headings “Risk Factors—Risks Related to our Business—If the FDA, the European Commission or other comparable foreign regulatory authorities approve generic versions of neffy or our current or future intranasal epinephrine technology product candidates that receives regulatory approval, or such authorities do not grant our products appropriate periods of non-patent exclusivity before approving generic versions of such products, the sales of such products could be adversely affected” and “Risk Factors—Risks Related to Our Intellectual Property” in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, filed with the Securities and Exchange Commission on August 13, 2025.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| ARS PHARMACEUTICALS, INC. | ||||||
| Date: August 27, 2025 | By: | /s/ Richard Lowenthal, M.S., MSEL | ||||
| Richard Lowenthal, M.S., MSEL | ||||||
| President and Chief Executive Officer | ||||||
| (Principal Executive Officer) | ||||||
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