pioneer drug


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pioneer drug

The brand-name or patented version of a drug, later copied to make generic drugs after the patent expires.
See also: drug
References in periodicals archive ?
26) However, into the 1980s, manufacturers of generic pharmaceuticals were required to perform the same expensive testing that the pioneer drug makers had already undergone.
32) To accomplish the first objective, the Hatch-Waxman Act's ANDA provided generics with a new approval process, during which generic producers need only prove the equivalency of their generic product to the pioneer drug on which FDA testing and approval had already taken place.
To aid concurrent development of generics, the Hatch-Waxman Amendments also allowed generic manufacturers to use the patented pioneer drug during the patent life to test and develop generics, which might otherwise be patent infringement.
68) However, the fact that brand-name pharmaceutical manufacturers maintain as significant a market share as they do presents an interesting problem: why would consumers continue to purchase a pioneer drug if they can buy the generic for half the price?
84) The American regulatory system is not designed for this new environment--the regime protects brand-name manufacturers with long exclusivity periods to shield their flagship pioneer drugs.