Teva to market generic Risperdal.
A U.S. District Court judge in Washington, has ruled that Teva
Pharmaceutical Industries Ltd. has the right to make and sell a generic
version of Risperdal (risperidone). Unless the ruling is challenged,
Teva can begin exclusive sales of risperidone on June 29, the date
Johnson & Johnson's patent for Risperdal expires. The FDA and
generic pharmaceutical manufacturer Mylan Inc. had argued that Teva
should not be allowed to have exclusive rights to the generic version of
the drug. But U.S. District Court Judge Royce Lamberth disagreed. In the
meantime, J&J and its partner Alkermes Inc. have applied to the FDA
to sell a long-acting form of the drug, Risperdal Consta, for frequently
relapsing bipolar disorder, defined as four or more manic episodes in
the previous year. Alkermes estimates that 10%-20% of people with
bipolar disorder worldwide meet that criterion.