Amicus Therapeutics Enters License Agreement With Teva, Resolving Galafold Patent Litigation; No Terms Disclosed
Amicus Therapeutics Enters License Agreement With Teva, Resolving Galafold Patent Litigation; No Terms Disclosed
This Agreement resolves the patent litigation brought by Amicus in response to Teva's Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of GALAFOLD (migalastat) 123mg capsules prior to expiration of the applicable patents.
本協議解決了Amicus針對Teva的縮寫新藥申請（ANDA）提出的專利訴訟，該申請尋求在適用專利到期前批准上市GALAFOLD（migalastat）123毫克膠囊的仿製版本。
Pursuant to the terms of the Agreement, Amicus will grant Teva a license to market its generic version of GALAFOLD in the United States beginning on January 30, 2037, if approved by the U.S. Food and Drug Administration (FDA) and unless certain limited circumstances customarily included in these types of agreements occur.
根據協議條款，如果獲得美國食品和藥物管理局（FDA）的批准，並且沒有發生通常包含在這類協議中的特定有限情況，則Amicus將授予Teva在美國市場上GALAFOLD的仿製版本的許可，始於2037年1月30日。
In accordance with the Agreement, the parties will terminate all ongoing Hatch-Waxman litigation between Amicus and Teva regarding GALAFOLD patents pending in the U.S. District Court for the District of Delaware. The litigation will continue against Aurobindo1 as the remaining active party and the litigation stay remains in place for Lupin.
根據協議，雙方將終止Amicus和Teva在特拉華區地區法院關於美國特拉華區待定的GALAFOLD專利的所有進行中的Hatch-Waxman訴訟。訴訟將繼續針對Aurobindo1作爲剩餘主動方，並針對Lupin的訴訟暫緩仍然有效。
譯文內容由第三人軟體翻譯。
