---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-25-190202"
form_type: "8-K"
ticker: "SPRY"
cik: "0001671858"
company_name: "ARS Pharmaceuticals, Inc."
filed_at: "2025-08-28T23:59:59+00:00"
generated_at: "2026-05-17T09:28:40.960133+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# ARS Pharma receives Paragraph IV notice from Lupin for generic neffy; intends to sue

## Summary
- Lupin filed ANDA for generic version of neffy (epinephrine nasal spray) before expiration of 8 Orange Book-listed patents.
- Notice alleges patents are invalid, unenforceable, or not infringed; ARS plans to file patent infringement suit within 45 days.
- Filing suit within 45 days triggers automatic 30-month FDA approval stay; company vows to vigorously defend IP.
- As of filing, no other ANDA filers known; neffy is ARS's sole marketed product.

## SEC filing metadata
- accession: 0001193125-25-190202
- form_type: 8-K
- ticker: SPRY
- cik: 0001671858
- company_name: ARS Pharmaceuticals, Inc.
- filed_at: 2025-08-28T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1671858/000119312525190202/0001193125-25-190202-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1671858/000119312525190202/d88536d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-25-190202
- JSON: https://secwatch.observer/filing/0001193125-25-190202.json
- Plain text: https://secwatch.observer/filing/0001193125-25-190202.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.