Generic drug manufacturers

Pharmacokinetic studies are so important in the pharmaceutical arena, that they play the central role in FDA approval of generic versions of drugs. A generic drug manufacturer has to demonstrate to the FDA s satisfaction a capability to manufacture the drug with appropriate levels of quality. But beyond that, the generic manufacturer need... 

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. ... 

Returning to biologies, it seems that the technology is so specialized that any intervention by generic drug manufacturers when the patent(s) expire is unlikely to significantly reduce the cost to the consumer, and it may well be much less than that anticipated by some journalists. 

Another interesting part of this law is that if a generic drug manufacturer challenges a patent and is successful, it is rewarded with a 6 month period during which no other generic products will be approved. 

In this manner, the approval of an ANDA is, in part, dependent on the generic drug manufacturer avoiding infringement of the innovator s patents. The first step to avoiding infringement of the innovator s patents is to identify the particular patents that cover a particular approved product. 

Quaker Road P.O. Box 2900 Pomona, NY 10970 Fax 914-353-3317 E-mail hr barrlabs.com Internet site with job bank www.barrlabs.com a generic drug manufacturer solicits e-mailed resumes... 

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