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 从近期医药改革想到 |
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Questions about brandname drugs after patent expiration -- 简 - (643 Byte) 2005-8-16 周二, 10:30 (306 reads) |
ilcure
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作者：游客 在 项目找投资与合作 发贴, 来自【海归网】 http://www.haiguinet.com
The most obvious is to develop novel products, i.e., drugs of next generation, improved formulation, etc. A good example is Novo Nordisk, which has been successfully making and selling insulin for years. If the pipeline is dry and the revenue from the current product is critical for survival, then by all means to deter generic competition. There are a few tactics you can use: develop your own generic formula and become the first to file paragraph IV against your own brand name drug, sue other ANDA applicants for patent infringement and get a 30-month stay in FDA approval, and pay the successful ANDA applicant not to launch their generic products or at least park their 180-day exclusivity. The goal is to prolong your own market exclusivity. If it is not possible, then prevent the generic manufacture selling their products at discounted price. However, when you take these measures, be careful not to violate the antitrust law.
Filing citizen's petitions, however, usually doesn't cause significant delays in FDA approval of ANDA.
With the new GAAP legislation passed on the hill, the tide seems to be turned against brand name drug makers. They may have to think about using better prices to compete with generic drug manufactures. Once the drug price is lowered, its copay will also decrease.
作者：游客 在 项目找投资与合作 发贴, 来自【海归网】 http://www.haiguinet.com
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