Novartis AG (NYSE:NVS) reportedly faced a legal setback as it failed to convince a federal court to block MSN Pharmaceuticals from launching a generic version of its heart-failure drug, Entresto.
On Monday, U.S. District Judge Richard Andrews in Delaware ruled that Novartis' likelihood of winning its patent-infringement lawsuit was too low to justify stopping MSN Pharmaceuticals' launch.
Also Read: Novartis Sues to Block Maryland's New Drug Discount Law.
Despite this ruling, the judge temporarily suspended MSN Pharmaceuticals' sales while Novartis appealed to the U.S. Court of Appeals for the Federal Circuit.
Entresto is Novartis' top-selling drug. In the second quarter, it generated sales of $1.89 billion, up 25% year over year (+28% on constant currency).
The FDA approved MSN Pharmaceuticals' version of Entresto in July, making it the first generic available in the U.S.
Novartis, which initially sued MSN Pharmaceuticals and other companies in 2022 over patent infringement, requested a preliminary injunction on August 2 to halt MSN Pharmaceuticals' launch, but the court denied this request.
Reuters noted that Judge Andrews dismissed Novartis' concerns about potential "irreparable harm" that could arise from a wave of generic launches by other manufacturers if MSN Pharmaceuticals' version were released.
The judge's ruling places additional pressure on Novartis, now considering "all available options" to defend its intellectual property rights.
Despite the legal challenges, the company maintains its financial outlook for 2024.
As the legal battle continues, Novartis has also sought to block MSN Pharmaceuticals' launch through a separate lawsuit in a Washington, D.C. district court, challenging the FDA's decision to approve the generic. The outcome of that case remains pending.
Price Action: NVS stock is up 0.25% to $111.69 at the last check on Tuesday.
Disclaimer: This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.
據報道,諾華公司(紐約證券交易所代碼:NVS)因未能說服聯邦法院阻止MSN Pharmicals推出其心力衰竭藥物Entresto的仿製藥而面臨法律挫折。
週一,特拉華州的美國地方法院法官理查德·安德魯斯裁定,諾華贏得專利侵權訴訟的可能性太低,不足以證明停止MSN Pharmaceuticals的上市是合理的。
另請閱讀:諾華起訴阻止馬里蘭州的新藥品折扣法。
儘管作出了這一裁決,但法官暫時暫停了MSN Pharmaceuticals的銷售,而諾華則向美國聯邦巡迴上訴法院提出了上訴。
Entresto是諾華最暢銷的藥物。在第二季度,它創造了18.9億美元的銷售額,同比增長25%(按固定匯率計算增長28%)。
美國食品藥品管理局於7月批准了MSN Pharmaceuticals版本的Entresto,使其成爲美國首款上市的仿製藥。
諾華最初於2022年以專利侵權爲由起訴MSN製藥和其他公司,於8月2日要求發佈初步禁令,以阻止MSN Pharmaceuticals的推出,但法院駁回了這一請求。
據路透社指出,安德魯斯法官駁回了諾華的擔憂,即如果MSN Pharmaceuticals的版本發佈,其他製造商的仿製藥發佈浪潮可能會造成潛在的 「無法彌補的損害」。
法官的裁決給諾華帶來了額外的壓力,諾華現在正在考慮 「所有可用的選擇」 來捍衛其知識產權。
儘管面臨法律挑戰,但該公司仍維持其2024年的財務前景。
隨着法律鬥爭的繼續,諾華還試圖通過華盛頓特區地方法院的另一項訴訟阻止MSN Pharmaceuticals的上市,質疑美國食品藥品管理局批准該仿製藥的決定。該案的結果仍懸而未決。
價格走勢:在週二的最後一次支票中,NVS股價上漲0.25%,至111.69美元。
免責聲明:此內容部分是在人工智能工具的幫助下製作的,並由Benzinga的編輯審閱和發佈。