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 ?
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.
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.
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.
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.
In their recently concluded study entitled "Generic Pharmaceutical Litigation: Regulatory Outlook and Strategic Analysis," the analysts found that pioneer drug manufacturers are facing increased generic drug threats to their best-sellers.
This warning on the potential risks of treating patients with PPIs was also the subject of a talk at the Mayo Clinic in September, 2002 by Sir James Black, who received the Nobel Prize for his invention and development of Tagamet, the pioneer drug for treating GERD and ulcerations.