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Big pharma FINAL.doc

Term restoration act was a bill that changed the

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Term Restoration Act, was a bill that changed the government regulations for generic drugs in the US. It made it easier for generic drugs to enter the market while still being safe and effective. The bill was approved in 1984. Under the bill, generic drug manufacturers only have to submit an ANDA to prove it is equal to the original drug. This is cheaper for the generic manufacturers because they do not have to conduct clinical studies. Patents and exclusivities are forms of protection for drug makers that can affect how and when a generic drug is approved and can be sold. Patents are issued by the
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U.S. Patent and Trademark Office and usually protect new brand-name drugs. They prohibit others from selling generic versions of the same drug. In the Hatch-Waxman Act it is also stated that ANDAs can’t be filed and the generic drugs cannot go on market until the branded drug’s patent expires. The Act also provide the first drug to file an ANDA a 180-day period of exclusivity. Because branded drugs lose so much of their revenue when generic drugs are introduced, the Act provides them with patent extensions options, which now average about three years. (Baltazar) Like we mentioned earlier, a generic medicine works in the same way and provides the same clinical benefit as its brand-name version. We can conclude a few more significant reasons why big pharmacy should not be permitted to discourage access to generic drugs. Demographic Trends Recent research shows: In 2015, the population of the United States over 65 is expected to reach 47.7 million, and by 2020, this number will grow by 17% to 55.9 million. The elderly population is the primary consumer of pharmaceutical products, and population growth will undoubtedly promote the use of generic drugs. Also, consumers, doctors and pharmacists continue to increase their acceptance of generic medicines. As a cheap alternative to brand drugs, generic drugs are becoming more and more common, which also has a positive impact on the generic drug market. Number of Products whose Patents Expire The gradual expiration of brand patents will promote the growth of generic drugs. According to Evaluate Pharma, the sales of brand drugs whose patents expire between
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2013 and 2015 are totally $124 billion, compared with $258 billion between 2013 and 2019. As the world's largest pharmaceutical market, generic drugs in the United States benefit most in the process of replacing brand drugs. Also, with the increase in expired patents, generic drugs will also face more growth opportunities in the areas of products with high barriers, high profits and longer life cycles. Entry Barriers In the generic industry, multiple factors affect the barriers to entry of the above products, such as: (i)Challenging regulatory requirements, including the current good manufacturing practice ("cGMP") and the higher regulatory standards of the U.S.
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  • Spring '13
  • Astone
  • Generic drug, Food and Drug Administration, Generic drugs, Drug Price Competition and Patent Term Restoration Act, Abbreviated New Drug Application

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