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

ARS Pharmaceuticals, Inc.

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.

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