On Thursday, Pfizer announced that it plans to introduce a generic version of its antidepressant Zoloft in the United States as soon as a rival generic hits the market, which could be as early as Saturday (in what is known as the sale of an “authorized generic”). The patent on Zoloft expires in two days.
Pfizer spokesman Paul Fitzhenry confirmed that Pfizer’s Greenstone unit is ready to launch a generic version of Zoloft, also known by its active ingredient sertraline, “if and when others release” their generic versions of the drug.
A generic company that is first to break a branded drug’s patent is awarded a 180-day period of exclusivity over other generics. But an authorized generic can compete in this period. “Generic companies are aggravated because it means they don’t get a 180-day period of market exclusivity,” said Ira Loss, an analyst at Washington Analysis.
Teva inherited the rights to generic Zoloft through its acquisition of Ivax Corp. earlier this year. Ivax received Food and Drug Administration approval in December 2004 to sell a generic version of Zoloft after the patent expires, and 180 days of marketing exclusivity upon launch. However, the exclusivity period does not apply to authorized generics.
By launching their own generic products, branded companies hope to hang on to a bigger portion of sales from the drugs they developed and discourage generic companies from making aggressive, early patent challenges. Generic companies, however, say they are not deterred.
As more blockbuster drugs lose patent protection, greater attention has become focused on the practice of branded drug makers allowing “authorized generics,” or unbranded versions of branded drugs they control, to compete with dedicated generic drug makers. Over the next five years, brand-name prescription drugs representing about $50 billion in annual sales are scheduled to lose patent protection.
Teva downplayed the news, probably still stinging from Merck’s decision last week to sell its generic Zocor at prices well below other generic competitors, made through special deals with health care companies. (Teva has the 180-day exclusivity period for Zocor which went off-patent last Friday). Pfizer has not announced whether or not it will follow the same pricing strategy as Merck did for Zocor. If it does, do you think the FDA will stand up and take notice and put an end to these bad days for the generics?
