Patent exclusivity generic manufacturers

The end of the effective patent life does not always mark the end of exclusive marketing for the NCE. Some compounds may not have generic competitors for several years after the patent expires, either because of delays in FDA approval of generic versions or because the total market for the drug is too small to induce generic manufacturers to enter the market. Occasionally a process patent issued after the original patents will protect a product for some time. 

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. 

Because of the Abbreviated nomenclature in the ANDA title and because of the often shortened form of the NDA represented by the 505(b)2 NDA, there has been some confusion between the two applications. Perhaps the ANDA should have been called the Abbreviated Generic Drug Application form it is appropriate only as an application for a manufacturing variant of an approved (via an NDA) new drug, presumably off patent or exclusivity. The... 

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