Amicus Therapeutics Settles Patent Lawsuit Teva Pharmaceuticals Over Generic Version Of Its Rare Genetic Disorder Drug
- Amicus Therapeutics and Teva Pharmaceuticals have settled a patent lawsuit allowing Teva to market a generic version of the Fabry disease drug Galafold in the U.S. starting January 30, 2037, contingent on FDA approval.
- The settlement resolves all Hatch-Waxman litigation related to Galafold between Amicus and Teva, while litigation against Aurobindo continues and Lupin remains under litigation stay.
- The market reacted positively to the news, with Amicus shares increasing by 12.4% and Teva shares up by 0.47%, reflecting anticipation of market competition with a future generic entry.
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In a significant move that could impact the pharmaceutical landscape, Amicus Therapeutics has announced the settlement of a patent lawsuit with Teva Pharmaceuticals. The dispute centered around the generic version of Galafold, a medication used to treat Fabry disease, a rare genetic disorder. This settlement marks a crucial step towards resolving ongoing litigation and paves the way for potential market competition.
Background on Fabry Disease and Galafold
Fabry disease is a rare genetic disorder characterized by the accumulation of a fat molecule called globotriaosylceramide within the cells of the body. This accumulation leads to a variety of symptoms, including pain in the hands and feet, gastrointestinal issues, and potentially life-threatening complications like kidney failure and heart problems. Galafold, developed by Amicus Therapeutics, is a key treatment for this condition. It works by stabilizing the alpha-Gal A enzyme, which helps break down the globotriaosylceramide, thereby alleviating the symptoms associated with Fabry disease.
The Patent Dispute
The patent dispute between Amicus Therapeutics and Teva Pharmaceuticals revolved around Teva’s Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of Galafold. Amicus had initiated the patent litigation in response to this application, arguing that Teva’s actions would infringe on their intellectual property rights related to Galafold. The lawsuit was ongoing in the U.S. District Court for the District of Delaware as part of the Hatch-Waxman litigation process.
The Settlement Agreement
On October 17, 2024, Amicus Therapeutics and Teva Pharmaceuticals announced a licensing agreement that resolves the patent litigation. According to the terms of the agreement, Amicus will grant Teva a license to market its generic version of Galafold in the United States starting on January 30, 2037. This date is contingent upon FDA approval and subject to certain limited conditions typically present in such agreements.
Key Points of the Settlement
- License Agreement: Amicus will permit Teva to sell its generic variant of Galafold in the U.S. starting January 30, 2037, provided it meets FDA approval requirements and excludes specific limited circumstances.
- Hatch-Waxman Litigation: The agreement concludes all ongoing Hatch-Waxman litigation between Amicus and Teva regarding Galafold patents currently in the U.S. District Court for the District of Delaware.
- Ongoing Litigation: The legal proceedings against Aurobindo will continue as the sole active party, while the litigation stay remains applicable for Lupin.
Impact on the Market and Shareholders
The settlement has generated significant interest among investors and market analysts. Teva’s stock has seen a minor increase of 0.47%, reaching $18.11, while Amicus Therapeutics shares have surged by 12.4%, now priced at $11.81. This reaction reflects the market's anticipation of potential competition and the eventual entry of a generic version of Galafold into the market.
Forward-Looking Statements
While the settlement agreement resolves the immediate patent dispute, it also highlights ongoing risks associated with patent litigation and market competition. Amicus Therapeutics cautioned that forward-looking statements are inherently uncertain and may differ from actual performance due to various risks and uncertainties, including unfavorable outcomes in related litigation and regulatory approvals.
Conclusion
The settlement between Amicus Therapeutics and Teva Pharmaceuticals marks a significant milestone in the pharmaceutical industry. It underscores the complexities of patent litigation and the strategic considerations involved in resolving such disputes. As the market waits for the generic version of Galafold to enter the market, it remains to be seen how this development will impact patient access and treatment options for those suffering from Fabry disease.
References
- https://finance.yahoo.com/news/amicus-therapeutics-settles-patent-lawsuit-150741097.html
- https://www.investing.com/news/company-news/amicus-therapeutics-settles-patent-litigation-with-teva-93CH-3669097
- https://www.globenewswire.com/news-release/2024/10/17/2964732/15991/en/Amicus-Therapeutics-Announces-Settlement-of-Galafold-migalastat-Patent-Litigation-with-Teva.html
- https://www.marketwatch.com/story/amicus-therapeutics-shares-rise-after-lawsuit-settlement-deal-with-teva-648f9fdc
