Judge's recent ruling and its impact on the Generics Industry

Interesting post by Ed Silverman on Pharmalot on the decision by US District Judge Berle Schiller to refuse to dismiss a lawsuit by consumers who allege two generic drugmakers failed to warn about side effects caused by differences in their versions of the Wellbutrin XL antidepressant.

Ed writes:
The lawsuit alleges that Teva Pharmaceuticals and Impax Laboratories became aware of the side effect issue, but failed to warn the public about differences that affected the release rate of the active ingredient. “A generic drug manufacturer is not absolved of liability because the FDA has approved its generic product,” Schiller wrote (read the ruling).

Some background: In 2003, GlaxoSmithKline released Wellbutrin XL, an extended-release form of the pill that could be taken just once daily and used a membrane-release technology, which meant the drug would seep at a controlled rate through a membrane that passed through the entire body intact, The Legal Intelligencer writes.

Since the membrane technology was patented, generic manufacturers who wanted to release a version of Wellbutrin XL were forced to devise their own methods of delayed release. Impax and Teva used a different matrix technology and their drugs achieved peak concentrations in two hours. Wellbutrin XL and generic versions made by other companies achieved this in five hours.

For patients who switched, the faster release made the drug less effective in combating depression, according to the lawsuit, which alleges neither Impax nor Teva took steps to warn doctors or patients that their versions worked differently or disclosed side effect complaints.

Bottom line - This decision obviously will have some impact on the Generic Industry. It has somewhat changed the landscape.

But the good companies in the industry will do what they have always done. They will see that the legal landscape has changed...they will adapt and make the necessary changes to deal with the changes...and they will continue to move forward.