Axsome receives ANDA Paragraph IV notice from Apotex for generic Symbravo

Axsome Therapeutics, Inc.

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.

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