UPDATE 1-U.S. court vacates Teva exclusivity on Risperdal
(Adds analyst comment, share reaction)
JERUSALEM, Sept 14 (Reuters) - A U.S. appeals court has overturned a ruling made earlier in the year that gave Teva Pharmaceutical Industries (TEVA.O) 180 days of exclusivity to sell a generic version of anti-psychotic drug Risperdal, Teva said on Sunday.
Israeli-based Teva (TEVA.TA), the world's largest generics drugmaker, said the ruling was issued by the U.S. Court of Appeals for the District of Columbia on Friday.
"As a result of this decision, the U.S. Food and Drug Administration is no longer enjoined from approving subsequent Abbreviated New Drug Applications," Teva said in a statement.
Teva, which is in the process of buying Barr Pharmaceuticals Inc BRL.N, said it intends to seek a stay of the court's decision pending further appeals.
Shares of Teva's Tel Aviv-listed shares were down 3.1 percent to 162.30 shekels on the news.
"If the decision sticks, the significance is that the FDA will be able to approve other generic versions for Risperdal," Yoav Burgan, an analyst at Leader Capital Markets, wrote in a client note, adding that this was a surprise for Teva.
This could mean Teva will have to compensate customers already supplied with its product for a decline in the value of their stocks, he said.
Burgan estimated 180 days of exclusivity would add $250 million to $300 million to Teva's 2008 sales and 12-15 cents to earnings per share.
Otherwise, "it is possible that Teva will not be able to meet its 2008 EPS forecast of $2.69-$2.75," he added.
A U.S. court in April ordered Teva be granted a request for 180 days of exclusivity selling a generic version of Johnson & Johnson's (JNJ.N) Risperdal known as risperidone. The branded version had U.S. sales of $2.6 billion in the 12 months ended March.
U.S. regulators in June approved Teva's generic version of Risperdal and Teva said on June 30 it had begun shipping the product -- helping the company achieve record sales in the third quarter.
The FDA had appealed that decision.
Exclusivity periods are generally granted to generic drugmakers under federal law as an incentive to challenge weak patents. (Reporting by Steven Scheer; Editing by Richard Hubbard)
