Harmony Biosciences receives generic challenge notices for WAKIX from Novugen and Lupin

Harmony Biosciences Holdings, Inc.

Novugen Pharma and Lupin Ltd. filed ANDAs seeking FDA approval to market generic pitolisant (WAKIX) before patent expiry.
Paragraph IV notices challenge U.S. Patents 8,486,947 & 8,207,197, expiring Sept 2029 and Mar 2030 respectively.
Patent 8,354,430 (expiring Feb 2026) is not challenged in the notices.
Company states it will vigorously defend its intellectual property rights for WAKIX.

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