Lupin ANDA alleges invalidity of ARS neffy patents; one patent survived IPR

Rhea-AI Filing Summary

ARS Pharmaceuticals received a notice that Lupin submitted an Abbreviated New Drug Application (ANDA) seeking approval to commercially manufacture, use, or sell a generic version of neffy 2 mg (epinephrine nasal spray). The notice alleges that multiple U.S. patents listed in the FDA Orange Book for neffy (including U.S. Patent Nos. 10,576,156 and 10,682,414, among others) are invalid, unenforceable, or not infringed by the proposed generic. The filing notes ARS previously successfully defended U.S. Patent No. 10,682,414 in an Inter Partes Review. ARS states it is not aware of other ANDA filers as of this filing date.

Positive

• Successfully defended U.S. Patent No. 10,682,414 in an Inter Partes Review, as stated in the filing
• Multiple patents are listed in the FDA Orange Book, indicating layered patent coverage for neffy

Negative

• Lupin submitted an ANDA alleging the listed patents are invalid, unenforceable, or not infringed, which could threaten ARS's market exclusivity for neffy
• Filing states the sales of neffy could be adversely affected if regulatory authorities approve generic versions or do not grant appropriate exclusivity periods

Insights

Financial Analyst

TL;DR: A competitor's ANDA challenges ARS's Orange Book patents, posing potential revenue risk if a generic gains approval.

The ANDA filing by Lupin initiates a regulatory and likely litigation process that targets the company’s listed patents for neffy 2 mg. The document explicitly lists eight U.S. patents and records that one of those patents (10,682,414) survived an Inter Partes Review, which is a favorable procedural outcome for ARS. However, the ANDA’s allegations of invalidity, unenforceability, or non-infringement directly threaten exclusivity for neffy. Material financial impact depends on litigation outcomes, timing of any generic entry, and whether regulators approve the ANDA or grant exclusivity periods; those outcomes are not provided in this filing.

IP Litigation Expert

TL;DR: Lupin’s ANDA triggers patent challenges; one listed patent previously withstood IPR, which could strengthen ARS’s defense.

The notice asserts noninfringement and invalidity across multiple Orange Book patents, a standard basis for ANDA litigation. The filing confirms U.S. Patent No. 10,682,414 survived an Inter Partes Review, indicating at least one patent has been upheld on review. The presence of multiple patents in the Orange Book is procedurally important because each patent can be separately challenged, and differing outcomes could affect the timing and scope of generic entry. The filing does not state any litigation filings, court decisions, or regulatory determinations at this time.

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

August 13, 2025

Date of Report (Date of earliest event reported)

ARS Pharmaceuticals, Inc.

(Exact name of registrant as specified in its charter)

Delaware		001-39756		81-1489190
(State or other jurisdiction of incorporation)		(Commission File Number)		(IRS Employer Identification No.)

11682 El Camino Real, Suite 300
San Diego, California		92130
(Address of principal executive offices)		(Zip Code)

Registrant’s telephone number, including area code: (858) 771-9307

Not Applicable

(Former name or former address, if changed since last report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligations of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, $0.0001 par value per share		SPRY		The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

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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FAQ

What did ARS Pharmaceuticals (SPRY) disclose about Lupin's ANDA?

The company disclosed that Lupin submitted an ANDA seeking approval for a generic neffy 2 mg product and alleges the listed Orange Book patents are invalid, unenforceable, or not infringed.

Which patents are specifically mentioned in the filing?

The filing lists 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 as the Patents in the Orange Book.

Has ARS had any successful patent defenses noted in this filing?

Yes. The filing states ARS successfully defended U.S. Patent No. 10,682,414 in an Inter Partes Review.

Does ARS report other ANDA filers for neffy?

As of the filing date, ARS states it is not aware of any other ANDA filers besides Lupin.

What potential business impact did ARS disclose?

ARS disclosed that approval of generic versions or lack of appropriate non-patent exclusivity could adversely affect sales of neffy or related intranasal epinephrine products.