斯宾塞·谢尔曼，药房.D.
临床药剂师，药房亚博真人官方版APP
什么时候药物成为非专利药?
当药物第一次被引入时, they are made available as brand name only for differing lengths of time depending on the particular drug. Individuals often want to know when a generic will be released for the 品牌药物 希望能降低药物的价格. 为了更好地理解这个, it is important to first know the process behind bringing a new drug to market.
当制药商开发一种新药时, one of the first steps they take is to file a patent for the compound or substance they will be using as the active ingredient in the medication. 这些专利是通过美国专利局申请和审查的 U.美国食品和药物管理局 (FDA). Should the FDA approve the patent, companies are given 20 years of patent life. Over the next 20 years the manufacturing company will begin to develop all aspects of the medication and eventually begin clinical trials to prove both safety and efficacy. Once this is completed the FDA will review all the information and study results again. 当FDA认为药物安全有效时, 他们会批准使用的, and the manufacturing company is then permitted to sell their drug.
当一种药物首次进入市场时, the FDA allows the company exclusive rights to sell their drug on a brand name basis while no other companies can produce a generic version for a certain amount of time. 这就是所谓的市场独占. This is to allow time for the manufacturing companies to recover the costs from the years spent 研究ing and developing the medication before others can introduce competing generics.
的 timeframe for market exclusivity has a very wide range depending on numerous situations. Most of a drug's market exclusivity comes from the time remaining on its original 20-year patent. 例如, 如果公司完成开发, 研究, FDA批准并在12年内将药物投放市场, 他们的20年专利期限还剩下8年. During the eight-year timeframe no other company can produce or sell a generic version. Additional time may also be allotted to the drug if it meets certain criteria set by the FDA.
的 孤儿药法案 provides incentives for pharmaceutical companies to develop drugs for rare diseases, which affect a small population and might not be profitable otherwise. 如果一种药物符合孤儿药资格, 其中包括治疗影响不到200人的疾病,000人在美国.S.在美国，它可以获得7年的市场专营权. 在此期间, the manufacturer has the exclusive right to produce and sell the drug for the specific condition, 使他们能够收回研发成本. This provision encourages drug development for rare diseases and diseases with limited treatment options.
Market exclusivity can also be extended or shortened if companies challenge the FDA’s decisions. Additionally, there are other ways to extend the market exclusivity of a drug. 例如, 奥施康定, 哪个品牌是羟考酮ER, 从20世纪90年代末就开始了吗, 但它仍然没有真正的通用等价物. 奥施康定 changed its formulation to be abuse deterrent in 2010, 这样做的时候, 羟考酮ER仿制药不再等效. Given this, 奥施康定 remains without a true authorized generic for the time being. A formulation change like this is one popular example of how drugs can extend their market exclusivity.
一旦市场排斥结束, other companies can produce generic versions of the medication and prices can sometimes drastically drop for individuals and insurers. 的 average market exclusivity period for newly approved drugs is more than 12 years. So, it may be quite a while before a newer innovative drug has a generic available. If you have a question regarding a specific medication and would like to know when a generic may be available, 与我们联系 Ask的Pharmacist@米切尔.com and our team will do the 研究 and gather the information needed to best answer your questions.
此信息旨在作为总体概述, and any specific questions or concerns should be more fully reviewed with your health care professional such as the prescribing doctor or dispensing pharmacist.
Do you have a workers’ compensation or auto related pharmacy question? 给我们发邮件 Ask的Pharmacist@米切尔.com.
要阅读更多的问药剂师文章，请访问 米切尔.com/ask-the-pharmacist.
引用:
http://www.commonwealthfund.org/publications/journal-article/2017/sep/determinants-market-exclusivity-prescription-drugs-united#:~:text=The%20time%20remaining%20on%20a,for%20a%2020%2Dyear%20patent.
http://www.fda.gov/drugs/development-approval-process-drugs/frequently-asked-questions-patents-and-exclusivity