Leader Capital Markets analysts sees little chance of success for the lawsuit filed by Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) against the US Food and Drug Administration over exclusivity for its version of Janssen Pharmaceutical’s Risperdal tablets. Risperdal, whose generic name is risperidone, is a treatment for schizophrenia with annual sales of some $3.5 billion. Teva announced yesterday today that its US subsidiary had filed a lawsuit seeking an order requiring the FDA to relist in the Orange Book US Patent No. 5,158,952 and grant Teva 180-day exclusivity for a generic version of Risperdal.
Teva argues that the FDA's denial of Teva’s Citizen’s Petition, seeking the relisting of US Patent No. 5,158,952 and restoration of Teva’s 180-day exclusivity for its pending abbreviated new drug application for risperidone tablets, was unlawful. Teva disputes that the agency provided legal notice that the patent had been delisted before Teva’s submission of a Paragraph IV certification to that patent. That submission was made in 2001, and Teva argues that, because it was the first to challenge the patent it should benefit from a 180-day exclusivity period for its generic version. The FDA ruled that because it removed the patent from its Orange Book, also in 2001, Teva's submission also fell.
Leader analyst Yoav Burgan says that Risperdal should not be treated as part of Teva's pipeline, and that "without exclusivity, Risperdal's contribution to Teva will be negligible." Nevertheless, he adds that, should Teva succeed in obtaining an exclusivity period, this will add some $250 million to its sales, worth $0.14-0.15 in earnings per share. Burgan maintains a $54 price target for Teva.
Published by Globes [online], Israel business news - www.globes.co.il - on March 5, 2008
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