Harmony Biosciences Secures Patent Position with Settlement in WAKIX® Generic Litigation

Reuters

06-05

Harmony Biosciences Secures Patent Position with Settlement in WAKIX® Generic Litigation

Harmony Biosciences Holdings Inc. has announced a settlement agreement with Lupin Limited, resolving patent infringement litigation over Lupin's attempt to produce a generic version of WAKIX® (pitolisant hydrochloride). Under the agreement, Lupin will be able to launch its generic product no earlier than January 2030, or potentially in July 2030 with pediatric exclusivity. Additionally, the U.S. Patent Office Patent Trial and Appeal Board recently upheld the validity of Harmony's exclusively licensed polymorph patent for pitolisant hydrochloride by declining to initiate an Ex Parte Reexamination. Harmony continues to defend its intellectual property, reinforcing its patent portfolio's strength, which protects its innovations in sleep/wake therapeutics.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Harmony Biosciences Holdings Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20250605623408) on June 05, 2025, and is solely responsible for the information contained therein.

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Harmony Biosciences Holdings Inc. published the original content used to generate this news brief via Business Wire (Ref. ID: 20250605623408) on June 05, 2025, and is solely responsible for the information contained therein.</span></em>\n</div></body></html>\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":null,"symbol_name":null,"start_time":0,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20250605:nNDL49f2Tw:1","article_id":"2541020315","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2541020315","pubTimestamp":1749125117,"columns":[],"sourceInfo":null,"weMediaInfo":{"media_name":"Reuters","introduction":"Reuters.com brings you the latest news from around the world, covering breaking news in markets, business, politics, entertainment and technology","home_visible":1,"id":"1032215980","head_image":"https://community-static.tradeup.com/news/4567337cbdf294b657b1fa87c5488b48"},"summary":"Harmony Biosciences Holdings Inc. has announced a settlement agreement with Lupin Limited, resolving patent infringement litigation over Lupin's attempt to produce a generic version of WAKIX . 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