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Advances in drug development: The generic drug shortage

机译:药物开发的进展:通用药物短缺

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GT In the early 1980s, the generic drug industry underwent a massive legislative overhaul in what is now called the Hatch-Waxman legislation. It was a fairly broad legislation, with 2 components: one that concerned clarification and changes in patent law, and another that enacted legislation making it easier for generics to enter the market. As a result, generic drugs came on the market faster, there was more competition, and the prices for these drugs dropped more rapidly. These were all advantageous for the consumer, initially. However, the drug prices decreased so much that they were barely above the cost to manufacture them. The margins came down significantly. Oftentimes, if a brand-name drug with a higher profit margin is available, manufacturers will stop producing its generic.
机译:GT在1980年代初期,仿制药行业经历了大规模的立法改革,该立法现在被称为Hatch-Waxman立法。这是一项相当广泛的立法,包含两个组成部分:一个涉及专利法的澄清和变更,另一个涉及制定法律,使仿制药更容易进入市场。结果,仿制药更快地进入市场,竞争更加激烈,这些药物的价格下降得更快。最初,这些对消费者都是有利的。但是,药品价格下降得如此之快,以至于它们仅略高于制造成本。利润率大幅下降。通常,如果有更高利润率的名牌药品可用,制造商将停止生产其仿制药。

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