Pharmaceutical Pricing Practices, Utilization and Costs - Meeting Summary. 3. Projections of Drug Approvals, Patent Expirations, and Generic Entry from 2000 to 2004--Francis Palumbo, Ph.D., J.D.


According to Dr. Palumbo, 643 new prescription drugs are now in Phase II or Phase III clinical trials or are awaiting the Food and Drug Administration's (FDA) approval and potentially could enter the U.S. market by 2004. Many of these 643 products will probably not make it to the market, though, because later human trials will demonstrate lower than anticipated efficacy or unfavorable side effect profiles. Dr. Palumbo and his colleagues estimated that the patents will expire on about 45 brand-name prescription drugs each year from 2000 through 2004, potentially opening the market to generic competition. He noted, however, that brand-name drug manufacturers have several defensive strategies that they can use to block the market entry of generic products or discourage the utilization of generic products.