NATCO Pharma Ltd.

iStock, hapabapa Alongside the settlement, Novo and Viatris have asked the U.S. Patent and Trademark Office to terminate its review of the validity of the Danish drugmaker’s semaglutide patents. Novo Nordisk and Viatris subsidiary Mylan on Monday reached a settlement in their patent dispute over the blockbuster incretin therapy semaglutide. According to a filing by Indian company Natco Pharma, the terms of the settlement are confidential, so the companies’ financial arrangements are unknown. It is also unclear when generic versions of semaglutide are allowed to enter the U.S. market. Natco is partnered with Mylan on the development of these generics. In accordance with the settlement, Novo and Viatris on Monday also submitted a joint filing to the U.S. Patent and Trademark Office (PTO) asking it to terminate all proceedings and pending motions related to the patent dispute. Novo sued Mylan in 2022 claiming patent infringement. According to the lawsuit, filed in the District Court for the Northern District of West Virginia, Mylan had filed an abbreviated New Drug Application (ANDA) for a generic version of Ozempic, the brand of semaglutide indicated for type 2 diabetes. Novo argues that in filing its ANDA, Mylan signified its intention to “sell, offer to sell, use, and/or engage in the commercial manufacture” of an Ozempic generic that would violate nearly 20 of its patents that have yet to expire. In particular, Mylan’s generic uses protected technology related to the structure of the GLP-1 drug itself, the overall formulation of the medication and the injection device, among other characteristics. The pharma at the time asked the court to prevent Mylan from manufacturing and selling its generic version, pending approval, before the expiration of any of the patents under contention, including extensions. Novo has since filed other lawsuits against Mylan, including one in July 2024 that focused on two patents —concerning the pharmaceutical composition and specific use of semaglutide in type 2 diabetes—that Mylan’s ANDA allegedly violated. Mylan, meanwhile, has challenged the validity of Novo’s patents. According to Monday’s joint document to the U.S. PTO, Mylan filed for an inter partes review in March 2023. The PTO Board started its review a few months later, in October 2023. Ozempic works by mimicking the GLP-1 hormone and activating its corresponding receptor. Through this mechanism of action, Ozempic promotes the secretion of insulin from the pancreas in response to a rise in blood sugar levels. The drug also slows gastric emptying and helps suppress appetite. Ozempic’s sister brand Wegovy is indicated for chronic weight management. Ozempic made around $14 billion in 2023 , while Wegovy earned another $4.5 billion.

精彩内容 日前，国家药监局官网显示，江西山香药业的奥拉帕利片以仿制4类报产获批。米内网数据显示，奥拉帕利片在近年中国三大终端六大市场（统计范围见文末）销售规模均超过10亿元，2023年同比增长1.42%。今年以来，江西山香药业已有3款新品获批上市。 来源：米内网项目进度数据库 奥拉帕利片由阿斯利康研发，用于上皮性卵巢癌、输卵管癌或原发性腹膜癌等。 2023年中国三大终端六大市场内服抗肿瘤化药产品TOP20来源：米内网格局数据库 奥拉帕利片在近年中国三大终端六大市场销售规模均超过10亿元，2023年同比增长1.42%，是内服抗肿瘤化药TOP11产品。 米内网数据显示，奥拉帕利片有8家企业拥有生产批文，江西山香药业、上海宣泰医药、石药欧意药业等7家国内药企过评，阿斯利康和Natco Pharma Limited各有2个受理号报产在审。江西山香药业今年以来获批产品来源：米内网中国申报进度（MED）数据库今年以来，江西山香药业已有3款新品获批上市，美沙拉秦肠溶片报产在审。在2023年中国三大终端六大市场，硝苯地平控释片是50亿元级别的重磅产品，米拉贝隆缓释片是泌尿系统药物TOP8产品，美沙拉秦肠溶片是止泻药，肠道抗炎/抗感染药TOP6产品。 资料来源：国家药监局官网、米内网数据库 注：米内网《中国三大终端六大市场药品竞争格局》，统计范围是：城市公立医院和县级公立医院、城市社区中心和乡镇卫生院、城市实体药店和网上药店，不含民营医院、私人诊所、村卫生室，不含县乡村药店；上述销售额以产品在终端的平均零售价计算。如有疏漏，欢迎指正！ 本文为原创稿件，转载请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092 ●温馨提示● 因为微信公众号修改了推送规则，最近很多读者反映没有及时看到推文。 把米内网设为“星标”，就能每天与我们不见不散啦，具体操作如下： 【分享、点赞、在看】点一点不失联哦

The same day AstraZeneca and Merck & Co. were granted a new patent for their cancer drug Lynparza (olaparib), the partners filed new suits against Natco Pharma and Sandoz that allege the manufacturers’ respective generic compounds infringe on the PARP inhibitor’s patents. According to the plaintiffs, Natco Pharma submitted a regulatory application to the FDA at the end of 2022 seeking approval of its generic olaparib, and Sandoz filed an application with the US agency for its product in December 2023. After each submission was accepted for FDA review, AstraZeneca and Merck first filed suit against the companies claiming infringement against four Lynparza patents; namely, 7,449,464; 8,475,842; 11,633,396; and  8,859,562. Both suits are still pending. The fresh lawsuits, filed this week in New Jersey District Court, were triggered after the pharma partners were issued two new patents. The US Patent and Trademark office granted the 11,970,530 patent on April 30 and the 11,975,001 patent on May 7. The former is for a method of treating homologous recombination deficient cancers, such as ovarian and pancreatic cancer, that combines Roche's anti-VEGF antibody Avastin (bevacizumab) with Lynparza. The latter covers an immediate release formulation Lynparza.