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Essay / Research Paper Abstract
A 4 page paper that reports a brief history of the generic pharmaceutical industry. Examples of generic companies are provided and the writer comments on the effect of the generic companies on the pharmaceutical industry. Bibliography lists 9 sources.
Page Count:
4 pages (~225 words per page)
File: MM12_PGgnrc.rtf
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Unformatted sample text from the term paper:
company, 2003). This is what opened the door for the development of generic products (Barr Pharmaceutical company, 2003). More than 3,000 products were evaluated ending in a list of those
that did what they claimed to do and those that were ineffective (Barr Pharmaceutical company, 2003). This review allowed generic manufacturers to apply for approval to manufacture all those
drugs on the effective list but for which patents had expired (Barr Pharmaceutical company, 2003). Since the drug was already proven to be effective, generic companies did not need to
perform the very costly trials and studies (Barr Pharmaceutical company, 2003). It would be another decade before legislation was passed that provided the needed environment for generics (Barr Pharmaceutical company,
2003). What really set the scene for generics was the Drug Price Competition and Patent Restoration Act that was passed in 1984, a law that is commonly referred to as
the Hatch-Waxman Act (Barr Pharmaceutical company, 2003). Generic companies could now file for all drugs manufactured after 1962 although the new law did require companies to "submit detailed information regarding
bioequivalence, manufacturing processes" (Barr Pharmaceutical company, 2003), to prove the drug was the equivalent to the branded product (Barr Pharmaceutical company, 2003). Competition became fierce with more than 1,000 applications
for generic drugs in less than a year (Barr Pharmaceutical company, 2003). In 1998, the Congressional Budget Office issued a report stating the generic pharmaceutical industry had provided significant savings
to consumers: "CBO estimates that in 1994, purchasers saved a total of $8 billion to $10 billion on prescriptions at retail pharmacies by substituting generic drugs for their brand-name counterparts"
(Barr Pharmaceutical company, 2003). An interesting statement in the report had to do with the benefit to pharmaceutical companies - generics led to more innovations in brand companies, the competition
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