FDA Denies Watson Exclusivity on Diabetes Drug, Prompting Lawsuit

August 16, 2012 – In The News
NJ Biz
Parsippany-based Watson Pharmaceuticals Inc. recently sued the U.S. Food and Drug Administration for denying its exclusivity period with three other pharmaceutical companies to launch the first federally approved generic version of a diabetes drug.

The move was sparked by the FDA refusing to approve Watson’s abbreviated new drug applications (ANDAs) for a generic version of Takeda Global Research & Development Center Inc.’s brand-name Actos drug. The FDA’s refusal to approve Watson’s ANDA could delay the launch of its generic product for at least six months.

Gerard P. Norton, Ph.D., chair of the firm’s Intellectual Property department, recently spoke to NJ Biz about the issue.

“One player now has 100 percent of this market, and that’s Takeda with its Actos drug. You get up to 30 percent of the market share within a year of a generic's launch, but each entrant after that period is only going to get a little piece of it — so that 180-day head start is huge. If Watson has to wait those six months while the other three companies capture the market share, you can bet it's going to be in a position to fight (in court). Every day your drug is not on the market, it's a disadvantage to your company," Norton said.

Norton told NJ Biz that such arguments against the FDA are not uncommon, as similar controversy involving generic versions of multibillion-dollar brand-name profit engines like Pfizer Inc.'s Lipitor and Teva subsidiary Cephalon Inc.'s Provigil have cropped up in the past year.

"Anytime the FDA rules like this, it's adverse to the drug company," Norton said. "There's a wrecking ball aimed at their house. It's a good idea for them to seek immediate relief.”

Norton believes that the case will not go to trial for at least more than six months from now.

View entire article.