Harmony Biosciences settles WAKIX patent suit with Lupin, generic entry set for 2030

Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) said on June 5, 2025 that it has reached a settlement agreement with Lupin Limited that resolves the patent infringement litigation over Lupin's generic version of its narcolepsy drug WAKIX (pitolisant hydrochloride). The case is in the United States District Court for the District of Delaware. The filing names Lupin Limited as the company whose generic drug application the litigation concerns and as Harmony's counterparty in the settlement; it does not describe either side as plaintiff or defendant. The company reported the settlement in a Form 8-K filed June 5, 2025.

What the settlement says

The litigation relates to Lupin's Abbreviated New Drug Application, or ANDA, for a generic version of WAKIX. An ANDA is the filing a generic drug maker submits to the FDA to seek approval of a copy of an approved drug. As part of the settlement, the Delaware litigation will be dismissed.

Lupin will receive a license to launch its generic product no earlier than January 2030, or July 2030 with pediatric exclusivity. The 8-K says the date can be earlier under certain circumstances. Harmony's press release, attached as Exhibit 99.1, says the company had asserted multiple patents covering WAKIX.

Harmony's description of the outcome

The press release headline says Harmony strengthens its patent position with a favorable settlement. That is the company's own description of the result. It says the settlement "reinforces the validity and strength of Harmony's intellectual property portfolio."

Harmony also says it is advancing next-generation formulations of pitolisant, with utility patents filed with potential exclusivity to 2044. It points to a July 31, 2024 decision in which the U.S. Patent Office Patent Trial and Appeal Board declined, for the second time, to institute an Ex Parte Reexamination of its exclusively licensed polymorph patent for pitolisant hydrochloride.

Other generic challengers

The press release says Harmony will continue litigating its consolidated patent infringement case against several other companies that have filed ANDAs seeking approval for generic versions of WAKIX. The release does not name those companies. The company says it remains committed to vigorously defending its intellectual property.

About WAKIX and Harmony

According to the press release, WAKIX is the first and only non-scheduled FDA-approved treatment for excessive daytime sleepiness or cataplexy in adults with narcolepsy, and for excessive daytime sleepiness in pediatric patients 6 years of age and older with narcolepsy. It received orphan drug designation for narcolepsy in 2010 and breakthrough therapy designation for cataplexy in 2018. WAKIX was designed and developed by Bioprojet (France), and Harmony holds an exclusive license from Bioprojet to develop, manufacture and commercialize pitolisant in the United States.

In its annual report on Form 10-K filed February 25, 2025, Harmony describes WAKIX as its lead product. The FDA first approved it in 2019 for excessive daytime sleepiness in adult patients with narcolepsy, with approvals for cataplexy in 2020 and for pediatric patients six years and older in 2024. The company says it submitted a supplemental New Drug Application for pitolisant in idiopathic hypersomnia in the fourth quarter of 2024 and received a Refusal to File letter from the FDA in February 2025.

The 10-K also describes late-stage programs for pitolisant in Prader-Willi syndrome and myotonic dystrophy type 1. In October 2023, Harmony acquired Zynerba Pharmaceuticals, Inc., which added ZYN-002, a cannabidiol gel for Fragile X syndrome with a Phase 3 trial underway.

Who signed

SVP and General Counsel Christian Ulrich signed the 8-K for Harmony.

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