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大型藥企暢銷藥遭遇專利懸崖困境

大型藥企暢銷藥遭遇專利懸崖困境

Sy Mukherjee 2017-02-16
對醫藥巨頭來說,專利藥物就是他們手上的現金牛。然而,倘若專利到期,其遭遇到的困境和市場激烈競爭是他們不得不面對的。

分析公司Dickson Data及FiercePharma的信息顯示,大量產品專利即將失效。而幾家醫藥巨頭今年也即將面臨賬本底線的重大考驗。

默克公司、諾華公司、百時美施貴寶公司以及禮來制藥的重要藥物均將面臨專利懸崖問題。

默克公司遭受的影響最大:在每年為其創收達5億美元的藥物中,不低于四分之一的藥物專利將于2017年失效。其中,抗生藥Invanz、降膽固醇藥Vytorin、抗真菌藥Cancidas,以及另一種抗生藥Cubicin在2015年為默克公司帶來了共計38億美元的收入,占到其2015年總銷售額的10%(Vytorin及Cubicin均為轟動一時的治療方法,年銷售額超過11億美元)。

其他主要治療方法的知識產權保護也將失效,包括諾華公司的注射用醋酸奧曲肽微球(Sandostatin LAR),用于治療肢端肥大癥和重癥腹瀉的治療方法——銷售額達16億美元;百時美施貴寶用于治療艾滋病的藥物Reyataz——銷售額達11.4億美元;以及禮來的用于治療注意力不集中癥(ADHD)的藥物Strattera——銷售額達7億美元。

Dickson表示,一旦某種藥物在市場上遇到屬類競爭者,隨著明顯低成本替代產品的出現,該種藥物的銷售額將平均下跌90%,下跌幅度令人難以置信。前述產品即將面臨一系列公司帶來的競爭,如輝瑞的子公司赫士睿、Teva藥業、太陽制藥,以及邁蘭公司。

未來幾年,面臨更激烈競爭的將不僅僅是上述品牌的藥物。

近年來在美國出現的仿制藥——或模仿全球暢銷并極其昂貴的“生物”治療品牌藥物——使得旗艦藥物的銷售難上加難,例如艾伯維公司和安進公司銷量第一的Humira和Enbrel兩種藥物。僅2015年一年,這兩種產品的全球銷量飆升至230億美元。(財富中文網)

作者:Sy Mukherjee

譯者: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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