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Generic drugs
After a new drug is approved for marketing, a patent will generally protect
the financial interests of the drug's developer for a number of years. The traditional
protection period is for 17 years. In reality, however, the period is much less
due to the extended period of time needed to gain approval before marketing
can begin. Recognizing that a considerable part of a drug's patent life may
be tied up in the approval process, in 1984 the U.S. Congress passed a law providing
patent extension for drugs whose commercial sale may have been unduly delayed
by the approval process.
Any manufacturer can apply for permission to produce and market a drug after
the patent for the drug has expired. Following a procedure called an Abbreviated
New Drug Application (ANDA), the applicant must show that its product is bioequivalent
to the original product. Although the extensive clinical testing completed by
the originator during the drug's development does not have to be repeated, comparative
testing between the products must be done to ensure that they will be therapeutically
equivalent.
Drug Quality
After an NDA or an ANDA has been approved for a product, the manufacturer must
then meet all requirements relating to production. These include the FDA's current
Good Manufacturing Practice regulations and any applicable standards relating
to strength, quality, purity, packaging, and labeling that are established by
the United States Pharmacopeia (USP).
Routine product testing by the manufacturer is required by the Good Manufacturing
Practice regulations of the FDA (the FDA itself does not routinely test all
products, except in cases where there is a suspicion that something is wrong).
In addition to governmental requirements, drug products must meet public standards
of strength, quality, and purity that are published in the USP. In order to
market their products, all manufacturers in the United States must meet USP-established
standards unless they specifically choose not to meet the standards for a particular
product. In this case, that product's label must state that it is "not USP"
and how it differs from USP standards (this occurs very rarely).
Source: Health Net
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