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大型药企畅销药遭遇专利悬崖困境

Sy Mukherjee 2017年02月16日

对医药巨头来说,专利药物就是他们手上的现金牛。然而,倘若专利到期,其遭遇到的困境和市场激烈竞争是他们不得不面对的。

分析公司Dickson Data及FiercePharma的信息显示,大量产品专利即将失效。而几家医药巨头今年也即将面临账本底线的重大考验。

默克公司、诺华公司、百时美施贵宝公司以及礼来制药的重要药物均将面临专利悬崖问题。

默克公司遭受的影响最大:在每年为其创收达5亿美元的药物中,不低于四分之一的药物专利将于2017年失效。其中,抗生药Invanz、降胆固醇药Vytorin、抗真菌药Cancidas,以及另一种抗生药Cubicin在2015年为默克公司带来了共计38亿美元的收入,占到其2015年总销售额的10%(Vytorin及Cubicin均为轰动一时的治疗方法,年销售额超过11亿美元)。

其他主要治疗方法的知识产权保护也将失效,包括诺华公司的注射用醋酸奥曲肽微球(Sandostatin LAR),用于治疗肢端肥大症和重症腹泻的治疗方法——销售额达16亿美元;百时美施贵宝用于治疗艾滋病的药物Reyataz——销售额达11.4亿美元;以及礼来的用于治疗注意力不集中症(ADHD)的药物Strattera——销售额达7亿美元。

Dickson表示,一旦某种药物在市场上遇到属类竞争者,随着明显低成本替代产品的出现,该种药物的销售额将平均下跌90%,下跌幅度令人难以置信。前述产品即将面临一系列公司带来的竞争,如辉瑞的子公司赫士睿、Teva药业、太阳制药,以及迈兰公司。

未来几年,面临更激烈竞争的将不仅仅是上述品牌的药物。

近年来在美国出现的仿制药——或模仿全球畅销并极其昂贵的“生物”治疗品牌药物——使得旗舰药物的销售难上加难,例如艾伯维公司和安进公司销量第一的Humira和Enbrel两种药物。仅2015年一年,这两种产品的全球销量飙升至230亿美元。(财富中文网)

作者:Sy Mukherjee

译者:司慧杰/汪皓

Patent cliffs are rough.

A slew of impending patent expirations could take a significant bite out of several pharma giants' bottom lines this year, according to information compiled by analytics firm Dickson Data and flagged by FiercePharma.

Merck, Novartis, Bristol-Myers Squibb, and Eli Lilly are all facing the patent cliff on important medications.

Merck has the most at stake: no less than four of its $500 million-per-year drugs have patents expiring in 2017. These treatments—antibiotic Invanz, cholesterol-fighter Vytorin, the antifungal Cancidas, and another anibiotic called Cubicin—totaled $3.8 billion in 2015 revenues for Merck, or 10% of its total 2015 sales (Vytorin and Cubicin are both blockbuster therapies with more than $1.1 billion in annual sales).

Other major therapies that will lose their IP protection include Novartis' Sandostatin LAR, a $1.6 billion-in-sales acromegaly and severe diarrhea treatment, Bristol-Myers' $1.14 billion HIV medicine Reyataz, and Lilly's $700 million ADHD drug Strattera.

As Dickson notes, once a drug faces generic competitors on the market, its sales drop by a staggering average of 90% thanks to significantly lower-cost alternatives. The aforementioned products are facing impending competition from a range of companies including Pfizer subsidiary Hospira, Teva, Sun Pharma, and Mylan.

These branded medications aren't the only ones that will be facing more and more competition in the coming years.

The recent advent of biosimilar drugs in America - or therapies that mimic brand name "biologic" treatments that tend to be extremely pricey and the best-selling treatments in the world - could start making things a little more difficult for flagship medicines like AbbVie's and Amgen's respective top sellers Humira and Enbrel. Those two products raked in $23 billion in global 2015 sales alone.


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