Pfizer announced that its subsidiary, Greenstone Ltd., will begin marketing an authorized generic version of Pfizer's anti-depressant Zoloft as soon as Teva introduces its generic version, which could happen as early as today. As reported by Reuters, Teva's share price fell 3.9% on the news. Teva, through its acquisition of Ivax, received 180 days of marketing exclusivity for generic Zoloft.
The Boston Globe reported that Teva took the news of Pfizer's plans in stride. According to a spokesperson for Teva, "The use of authorized generics by branded drug makers has been a common practice for years . . . . Teva always expects to compete against an authorized generic whenever it launches a product within 180 days of exclusivity."
A much different tone regarding authorized generics was sounded by the Generic Pharmaceutical Association (GPhA). In response to a report released by the Pharmaceutical Research and Manufacturers of America (PhRMA) concluding that authorized generics can lead to lower drug prices, GPhA issued a press release in which it urged Congress to prevent the introduction of authorized generics during the 180 day exclusivity period. GPhA asserted that authorized generics have appeared only in the last few years, and they represent "an anti-competitive response designed to deter generic companies from pursuing patent challenges by significantly diminishing the potential incentives" embodied in the 180 day exclusivity period.
The difference in tone could reflect the fact that individual generic companies currently have options for selling generic drugs during the 180 day exclusivity period: (a) trying to obtain the 180 day period of exclusivity under Hatch-Waxman, or (b) negotiating with brand drug companies to become authorized generic distributors during the 180 exclusivity period. The GPhA proposal would eliminate the second option, and may not be embraced by all GPhA member generic companies.
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