全球制药巨头鲁平有限公司周二宣布，在美国食品药品监督管理局批准其简略新药申请后，在美国推出Raltegravir Tablets USP, 600 mg（雷替格拉韦片USP，600毫克）。作为该产品的独家首家申请者，该公司有资格获得180天仿制药独家销售期。
Global pharma major Lupin Ltd on Tuesday announced the launch of Raltegravir Tablets USP, 600 mg, in the United States following approval from the US Food and Drug Administration for its Abbreviated New Drug Application .The company, which is the exclusive first-to-file for the product, is eligible for 180-day generic drug exclusivity.
Raltegravir Tablets USP, 600 mg与参比制剂Isentress HD Tablets, 600 mg（艾生特HD片，600毫克）具有生物等效性，后者由默克沙普多赫姆有限责任公司销售。
Raltegravir Tablets USP, 600 mg, are bioequivalent to the reference listed drug , Isentress HD Tablets, 600 mg, marketed by Merck Sharp & Dohme LLC.
汇丰银行表示，鲁平股价目前“过分强调”风险，同时“低估”利好因素。
该药物适用于与其他抗逆转录病毒药物联用，治疗体重至少40公斤的成人和儿童患者的艾滋病毒感染。
Lupin share price is currently 'overemphasizing' a risk while 'undermining' a positive, HSBC saysThe drug is indicated in combination with other antiretroviral agents for the treatment of Human Immunodeficiency Virus infection in adults and paediatric patients weighing at least 40 kg.
根据IQVIA MAT 2026年9月数据，Raltegravir Tablets USP, 600 mg在美国的预计年销售额为2600万美元。
According to IQVIA MAT September 2026 data, Raltegravir Tablets USP, 600 mg, had estimated annual sales of $26 million in the US.
昨天，鲁平获得美国食品药品监督管理局批准其Amifampridine Tablets, 10 mg（阿米法普利定片，10毫克），作为首批申请者之一，有资格获得180天共享仿制药独家销售期。鲁平获得美国FDA批准氯化锆钠环硅酸盐治疗高钾血症。
该批准针对公司提交的Amifampridine Tablets, 10 mg简略新药申请，该药与参比制剂Firdapse Tablets, 10 mg（菲达普斯片，10毫克）具有生物等效性，后者由Catalyst Pharmaceuticals Inc.（卡塔列制药公司）销售。公司表示，该片剂获批用于核准标签规定的适应症。
Yesterday, Lupin received approval from the United States Food and Drug Administration for its Amifampridine Tablets, 10 mg, and is eligible for 180 days of shared generic exclusivity as one of the first applicants to file for the drug. Lupin wins US FDA nod for sodium zirconium cyclosilicate to treat hyperkalemiaThe approval was granted for the company's Abbreviated New Drug Application for Amifampridine Tablets, 10 mg, which are bioequivalent to the reference listed drug , Firdapse Tablets, 10 mg, marketed by Catalyst Pharmaceuticals Inc.The tablets are approved for the indication specified in the approved labelling, the company said.
鲁平有限公司股价在孟买证券交易所收于2012.00印度卢比，上涨15.45印度卢比，涨幅0.77%。
Shares of Lupin Ltd ended at ₹2,012.00, up by ₹15.45, or 0.77%, on the BSE.