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 ?
of action for pioneer drug companies to sue those generic drug companies
(94) The Drug Price Competition and Patent Term Restoration Act, or Hatch-Waxman Act, set the stage for the manner in which generic drug manufacturers may gain permission to begin selling a generic version of a drug within the pioneer drug manufacturer's patent period.
Reverse payment settlements involving pay-for-delay payments involve a pioneer drug company paying the generic drug manufacturer to delay the entry of the generic version of the pioneer's drug in the market, usually after the generic manufacturer has filed an ANDA with a paragraph IV certification and litigation has begun.
(I) no patent related to the pioneer drug has been filed;
As described earlier, generic manufacturers create substitutes for pioneer drugs. With patent restrictions, these represent a copy-cat strategy more than a strategy that strikes at the foundations of the pioneer drug segment of the industry.
(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?
(13) To piggyback on the original NDA, the generic must demonstrate that its drug product is the "same" as the pioneer drug by submitting information to show that its product is pharmaceutically equivalent (14) and bioequivalent (15) to the pioneer approved drug.
(63) With the ANDA, the generic manufacturer need only demonstrate that its product is the bioequivalent of the pioneer drug and it can avoid duplicating the time-consuming tests.
How attorney's fees in ANDA litigation may impact pioneer drug companies
This decision will likely impact pioneer drug companies.