Consumers and health care professionals have an important role in helping to identify any previously unreported effects. New information may be added to the drug's labeling or the FDA can withdraw approval for marketing at any time f new evidence indicates the drug presents an imminent hazard. After a new drug is approved for marketing, a patient will generally protect the financial interests of the drug's developer for a number of years. The traditional protection period is 17 years but in reality the period is much less. Recognizing that a considerable part of a drug's patent life may be tied up in the approval process, Congress in 1984 passed a law providing patent extension for drugs who commercial sale may have been unduly delayed because of the approval process.
Any manufacturer can apply for permission to produce and market a drug after the patent has expired.
Although, the extensive clinical testing the original manufacturer had to complete during the drug's development does not have to be repeated, comparative testing between the products in question must be done to ensure that the products will indeed be the same. USP DI Drug Information for the Patient Volume II 13th Edition. All rights reserved. This site was updated April 2001 . This site is maintained by RPC Services.