US judge allows Teva to start shipping generic Lotrel again

by | 12th Jun 2007 | News

Teva Pharmaceutical Industries is in celebratory mood after a US court declared that the Israeli firm can resume sales of its generic version of Novartis’ hypertension treatment Lotrel.

Teva Pharmaceutical Industries is in celebratory mood after a US court declared that the Israeli firm can resume sales of its generic version of Novartis’ hypertension treatment Lotrel.

The US Court for the District of New Jersey found that Novartis’ patent-infringement lawsuit in defence of Lotrel (almodipine/benazepril), for which a date has still not been set, was not likely to succeed at trial, Teva said. A temporary restraining order against the Jerusalem-headquartered group which had been in place since the end of last month has therefore been lifted and the company is to start shipping its copycat version immediately.

This whole chain of events was set off by Teva beginning to sell its version of Lotrel after getting US Food and Drug Administration approval on May 18, but the following day, Novartis secured a temporary restraining order. Nevertheless, the judge rejected the Swiss drugmaker’s bid to force a recall of all Teva’s generic Lotrel and it is thought that the latter firm managed to ship three months’ supply of the drug in one day. Analysts noted that in its second week on the market, Teva’s version had already captured over 40% of total prescriptions in the Lotrel market.

Novartis launches own Lotrel generic

Novartis responded by saying that it “will continue pursuing its defence of intellectual property rights for Lotrel since its US patent is still valid until 2017”. If it loses the aforementioned suit, Teva “risks potentially significant damages,” said the Basel-headquartered firm which also announced that it has already launched its own “authorised generic version” of Lotrel in the USA through its Sandoz division.

Novartis had previously issued a warning about the effect Teva’s actions would have on its full-year earnings and sales projections, given that revenues from Lotrel in the USA last year reached $1.35 billion. The firm will now provide an update on July 17 when it posts its second-quarter results.

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