The Pharmaceutical Research and Manufacturers of America is defending industry patent settlements after an August 31 FTC report on authorized generics. PhRMA lauded the report's finding that an authorized generic is tied to lower prices for generics on the market before a 180-day market-exclusivity period's end, but added that a “potentially valuable report” furthered an attack on patent settlements.
“Authorized generics have not discouraged the availability of generics to patients,” the group stated. “Nearly 80% of prescriptions in the United States are already for generics, and the number of branded products facing Paragraph IV patent challenges has continued to grow.”
But FTC chairman Jon Leibowitz says “brand companies may be using the threat of launching an authorized ge-neric as a powerful inducement for generic companies to delay bringing their drugs to market.”
The FTC noted that more innovative drug companies are starting to market authorized generics while a generic firm is beginning its 180-day marketing exclusivity period, leading to questions about the effects of authorized generics on drug competition.