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Lupin has received the final approval from the USFDA for its ANDA for Pitolisant Tablets

ICICIdirect Research 18 Aug 2026 DISCLAIMER

 News: Lupin has received the final approval from the USFDA for its ANDA for Pitolisant Tablets. The medication is approved as bioequivalent to Wakix approved to treat excessive daytime sleepiness or cataplexy in patients.

View: According to multiple online sources, US sales of the medication in FY25 were ~$870 million, and the market remains relatively concentrated with only two key players, including the innovator. While we anticipate increased competition in the future, we still view the ANDA as a decent opportunity to strengthen Lupins U.S. portfolio.

Impact: Positive

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