---
schema_version: "secwatch.filing_event.v1"
accession: "0001579428-25-000007"
form_type: "8-K"
ticker: "AXSM"
cik: "0001579428"
company_name: "Axsome Therapeutics, Inc."
filed_at: "2025-08-20T23:59:59+00:00"
generated_at: "2026-05-17T11:08:52.700707+00:00"
event_type: "litigation"
sentiment: "negative"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# Axsome receives ANDA Paragraph IV notice from Apotex for generic Symbravo

## Summary
- Apotex filed an ANDA seeking FDA approval to market a generic version of Symbravo (meloxicam-rizatriptan benzoate).
- Paragraph IV certification notice received August 19, 2025; Axsame plans to respond in due course.
- If Axsame sues within 45 days, a 30-month stay could delay generic approval.
- Generic competition threatens Symbravo revenue, which is Axsome's key commercial product.

## SEC filing metadata
- accession: 0001579428-25-000007
- form_type: 8-K
- ticker: AXSM
- cik: 0001579428
- company_name: Axsome Therapeutics, Inc.
- filed_at: 2025-08-20T23:59:59+00:00
- event_type: litigation
- sentiment: negative
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1579428/000157942825000007/0001579428-25-000007-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1579428/000157942825000007/axsm-20250819.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001579428-25-000007
- JSON: https://secwatch.observer/filing/0001579428-25-000007.json
- Plain text: https://secwatch.observer/filing/0001579428-25-000007.txt

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