The FDA has approved the first generic versions of Johnson & Johnson's big-selling anticoagulant Xarelto, which brought in nearly $2.4 billion in US sales last year.

美国食品药品监督管理局（FDA）批准了强生公司畅销抗凝血药Xarelto的首个仿制药版本，该药物去年在美国的销售额接近24亿美元。

The US regulator has cleared 2.5mg tablet formulations of rivaroxaban – the active ingredient in Xarelto – from Sun Pharma subsidiary Taro Pharmaceuticals and Lupin, according to the Orange Book, which lists FDA-approved generic and brand name drugs.

根据列出FDA批准的仿制药和品牌药的橙皮书，美国监管机构已经批准了Sun Pharma子公司Taro Pharmaceuticals和Lupin生产的2.5毫克利伐沙班（Xarelto的活性成分）片剂配方。

In a statement, the FDA said it had approved the generics to reduce the risk of major cardiovascular events in adult patients with coronary artery disease (CAD) and to reduce the risk of major thrombotic vascular events in adult patients with peripheral artery disease (PAD), including patients who have recently undergone a lower extremity revascularisation procedure due to symptomatic PAD..

FDA 在一份声明中表示，已批准该仿制药用于降低冠状动脉疾病 (CAD) 成年患者发生重大心血管事件的风险，并降低外周动脉疾病 (PAD) 成年患者发生重大血栓性血管事件的风险，其中包括因有症状的 PAD 而近期接受过下肢血运重建术的患者。

J&J – which jointly developed Xarelto with Bayer – has US commercial rights to the drug and sells it as 2.5mg as well as 10mg, 15mg, and 25mg tablets along with a 1mg/ml oral suspension formulation.

强生与拜耳共同开发了利伐沙班，该公司拥有该药物的美国商业权利，并将其销售为2.5毫克、10毫克、15毫克和25毫克的片剂，以及1毫克/毫升的口服混悬液制剂。

The brand-name drug has been approved for a broader swathe of indications, including the treatment of non-valvular atrial fibrillation (AF) and recurrent blood clots and – according to Bayer – Xarelto 10mg, 15mg and 20mg tablets are also protected in the US by a patent for once-daily dosing 'beyond 2025.'.

该品牌药物已被批准用于更广泛的适应症，包括治疗非瓣膜性心房颤动（AF）和复发性血栓，并且根据拜耳公司称，Xarelto 10mg、15mg 和 20mg 片剂在美国也受到一项专利保护，该专利涉及每日一次给药方案，保护期“延续至 2025 年之后”。

The FDA said: 'Anticoagulants…are among the most commonly prescribed medications in the US, and Monday's approval of the first generics of rivaroxaban, 2.5mg, tablets will make a direct impact on American patients who rely on anticoagulant medications.'

FDA表示：“抗凝剂……是美国最常开的药物之一，周一批准了第一款2.5毫克利伐沙班片的仿制药，这将对依赖抗凝药物的美国患者产生直接影响。”

It's not clear exactly when the generics may become available, as the drug has some lingering protection with some sources estimating launch in May. Neither Taro nor Lupin have yet commented on their launch or pricing plans.

目前还不清楚仿制药究竟何时可能上市，因为该药物还有一些持续的保护，有消息人士估计可能在5月推出。Taro和Lupin都尚未对他们的上市或定价计划发表评论。

The lower dose of Xarelto is already facing competition in other markets, including Europe and Canada, with Bayer reporting today that ex-US sales fell 13% to €3.48 billion ($3.72 billion) last year. In Europe, the company expects to retain patent protection for the higher strengths of the drug until January 2026..

Xarelto的较低剂量已经在其他市场面临竞争，包括欧洲和加拿大。拜耳公司今天报告称，去年美国以外的销售额下降了13%，至34.8亿欧元（37.2亿美元）。在欧洲，该公司预计该药物的较高剂量专利保护将持续到2026年1月。

That patent has been subject to litigation and, while Bayer won the first round, the company acknowledges that it may have a fight on its hands defending the product, including efforts to circumvent it by using oral dosage forms other than tablets.

该专利一直面临诉讼，尽管拜耳赢得了第一轮，但该公司承认，它可能需要努力捍卫该产品，包括防止通过使用片剂以外的口服剂型来规避其专利。

Photo by

照片由

Towfiqu barbhuiya

拖菲克·巴布伊亚

on

打开

Unsplash

Unsplash