Patents generic drugs

An interesting scientific question raised by the new regulations was the point at which two drugs should be regarded as identical . The definition affects not only whether a novel drug could be patented as a new molecular entity but also whether an out-of-patent generic drug (see Section IV.D) could be approved on the basis of an AND A. 

As patents expire, exclusivity of producing a trade-nemed product will pass and competitive-versions of the basic drug will be marketed under generic names (or other new trade nemes) by new manufacturers. It has been estimated that 40% of the drugs on the market in 1990 will be generic drugs. 

Fines Enhancement Laws of 1984 and 1987 increase penalties for all federal crimes, with double fines for corporations. The Drug Price Competition and Patent Term Restoration Act expedites the availability of less-costly generic drugs by permitting FDA to approve generics without repeating the safety and effectiveness research. 

Federal Trade Commission (FTC), Generic drug entry prior to patent expiration. An FTC Study, FTC, Washington, DC, July, 2002. 

A generic drug is defined as a drug that is equivalent to a prescription drug approved by the FDA, but for which the patent validity has expired. An ANDA approval is required (Fig. 8.6). 

Generic Drug Entry Prier to Patent Expiration ... 

GENERIC DRUG ENTRY PRIOR TO PATENT EXPIRATION AN FTC STUDY... 

In spite of this reeord of sueeess, two of the provisions governing generie drug approval prior to patent expiration (the 180-day exelusivity and the 30-month stay provisions) are suseeptible to strategies that, in some cases, may have prevented the availability of more generic drugs. These provisions continue to have the potential for abuse. 

The study focuses solely on the procedures used to facilitate generic drug market entry prior to expiration of the patent(s) that protect the brand-name drug product. The study does not address other procedures for generic entry, and it does not address the patent restoration features of Hatch-Waxman. 

The Amendments provide certain methods by which generic drug manufacturers can obtain approval to market a generic version of a brand-name product. The study s purpose was to provide a more complete picture of how generic drug competition has developed under one method the Amendments established generic entry prior to expiration of the brand-name company s patents on the relevant drug product. This report sets forth the results of the study. ... 

The FDA denied both of these petitions. In each case, the brand-name company had sued the generic applicant for patent infringement, and the citizen petition was resolved by the FDA within the 30-month stay period. Thus, the petition had no effect on the timing of generic drug approval. 

Paragraph fV certification means a certification that a patent listed in the Orange Book is invalid or will not be infringed by the generic drug for which the ANDA applicant seeks approval. 

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