Wednesday, March 6, 2013

Pfizer 專利celecoxib延長(適應症) 成功痛擊學名藥廠 !!


輝瑞鎮痛藥專利獲延長 起多家訴仿製藥公司 鉅亨網新聞中心(來源:北美新浪)2013-03-06 08:31:49新浪財經訊 北京時間36凌晨消息,世界最大製藥商輝瑞公司(PFE)周二宣佈,其銷售額達數十億美元的鎮痛藥西樂葆( Celebrex )已獲美藥品監管機構授予再版專利,從而將其在這款藥物上的獨家營銷權延長一年半,至2015122。西樂葆去年在美國的銷售額高達17億美元以上,該藥原始的基本專利將於2014530到期。據統計,品牌藥一旦失去專利保護,在低成本仿製藥的競爭下,銷售額往往會很快下降80%以上。 輝瑞表示,已對幾家仿製藥製造商提起訴訟,后者正在尋求美國食品和藥品管理局(FDA)的批准,希望能從2014年開始在美國出售西樂葆的仿製版本。被起訴的包括以色列梯瓦製藥(TEVA)、米蘭製藥(MYL) Actavis Inc(原華生製藥,股票代碼ACT)、印度魯賓製藥(Lupin Pharmaceuticals),以及Apotex輝瑞希望能夠阻止這些公司在新的專利到期日之前出售仿製版的西樂葆。(羽箭)

 (Reuters) Mar 5, 2013 11:13am EST - U.S. regulators granted Pfizer Inc a reissued patent on its multibillion-dollar Celebrex pain drug that extends its marketing exclusivity until early December 2015, the company said on Tuesday. That will give Pfizer an additional 1 1/2 years of selling a drug that had U.S. sales of more than $1.7 billion in 2012, before cheaper generic versions begin to hit the market at the end of 2015. Branded drugs can quickly lose upwards of 80 percent of sales once multiple generic versions become widely available. The original basic patent for Celebrex - known chemically as celecoxib - expires on May 30, 2014, including six months of pediatric exclusivity for testing the drug in children. But the U.S. Patent & Trademark Office agreed to the reissued patent covering methods of treating arthritis and other approved conditions, Pfizer said. Pfizer said it filed lawsuits against several generic drugmakers that are seeking permission from the U.S. Food and Drug Administration to sell a generic version of the drug in the United States beginning in May 2014. Pfizer said it sued Teva Pharmaceutical Industries Ltd; Mylan Inc; Watson Pharmaceuticals, which has since changed its name to Actavis Inc; Lupin Pharmaceuticals; and Apotex to try to prevent them from selling their generic Celebrex until the new patent expires on December 2, 2015. Shares of Pfizer were up 1.4 percent at $28.09 in morning trading on the New York Stock Exchange.

 

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