药物专利过期后，药厂如何才能继续维持利润？

http://www.mitbbs.com/article_t/Pharmaceutical/31207747.html

发信人: tlexander (Bird), 信区: Pharmaceutical
标  题: 药物专利过期后，药厂如何才能继续维持利润？
发信站: BBS 未名空间站 (Tue Dec 29 23:06:56 2020, 美东)

药物专利过期，如何维持利润？

很困惑。Merck的两种治疗前列腺增生的药物今年6月19日过期。是否意味着其他药厂就可
以开始生产同类药物？是否会有价格战？最后价格会降得很低？

别的药厂如葛兰素史克的同类药物，专利要到2015年才过期。是否也得大降价，以抢夺市
场份额？如果必须降价，那还要专利干吗？再没有用了嘛!

还有一问，Merck如何延长专利？是否开发出新的用处就可以申请延长？譬如新研究发现
这类药可以降低血尿.

It's very tricky and complicated for such issues. Lots of law suit between
each other. But I personally welcome generic drugs.
我们现在上课做的case study就是如何延长专利很明显可以换剂型比如thermol patch,
IV injection之类

File for another line-extension product is the most common practice when
facing patent expiration.  For example, Toprol XL, Ambien CR.  You get a 3-
year extension and company will start to canabalize their in-line products
early to maintain market share.

Applying for a pediatric indication for a marketed product is also effective
way to prolong your patent (6 months to 3 years).  New indications in other
therapeutic areas usually will not help you maintain your marketing
exclusivity but Pharma company apply for them anyway while pushing the
product harder through different channels.

这种现象在制药界非常常见.当专利过期后,GENERICS的利润非常低,大药厂通常不屑于
过期后的利润.因为利润恐怕比原来的1/10还要低,因为几家同时生产,每家的市场分额
只有记分之一,价格又只有原来的几分之一.MERCK的药过期通常对别的的同类药冲击不
是非常大,因为个PHARMA都有自己的MARKETING TEAM.只要没有人能卖同样的药,医生还
开他们的药, 他们还是照样赚钱.  (问题是医生为何还开他们的药而不选择Generics?)

专利没有那么容易延长.缓释(CR)技术有些帮助,但帮助不大.毕竟不是所有的药的缓释
都一定会明显提高BENEFIT.另外GENERIC可以用公开的CR技术,只要他们能向FDA证明
BIOEQUAVALENCY,就可以了.SECOND INDICATION有时有帮助,但是FDA只给3年的
EXCLUSIVITY.而且如果剂量相同的话, GENERIC也还是可以Undercut你的市场.

Bioequivalence is a term in pharmacokinetics used to assess the expected in
vivo biological equivalence of two proprietary preparations of a drug. If
two products are said to be bioequivalent it means that they would be
expected to be, for all intents and purposes, the same.


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※ 修改:・tlexander 於 Dec 29 23:07:27 2020 修改本文・[FROM: 96.]