Teva loses over FDA over generic production of Copaxone

10 days before the patent of its multiple sclerosis drug expires, Teva Pharmaceutical Industries Ltd has lost its recent legal fight to block the approval of the generic form of Copaxone, Bloomberg reported. A federal judge in Washington has thrown out a lawsuit Teva has lodged against the US Food and Drug Administration over the improper dismissal of the pharmaceutical company's calls for additional testing of the generic forms of Copaxone before they are made available on the US market. The news agency said that Copaxone sales makes around have of Teva's profit.

In her order issued yesterday, US District Judge Ellen Huvelle said she dismissed Teva's lawsuit on the grounds that she does not have the authority to hear it and that the case was brought prematurely. She did say that Teva could be refiled at a later time.

Spokeswoman Denise Bradley for Teva said the company is evaluating its next steps following the dismissal of its recent lawsuit,

In a statement, Canonsburg, Pennsylvania-based Mylan Inc chief executive officer Heather Bresch, whose company produces one of the generic forms Teva is trying to block entry from the US market, said, "Teva's suit against FDA was simply a desperate, last-minute tactic. We continue to see no barrier to FDA approval of Mylan's generic Copaxone following patent expiry."

The May 10 lawsuit was reportedly the latest move of the Israel-based company to block rivals including Mylan and the Sandoz unit of Novartis AG from making a more cheaper generic version of its signature drug. Last month, Teva's bid for an injunction to prevent the sale of the contested products of its competitors has been blocked by a US Supreme Court justice.

On the other hand, it appears that Teva is still forging on to protect its most lucrative product. Bloomberg said that Teva is appealing the 2013 dismissal of its lawsuits against Mylan and Sandoz for infringing its patents that covers the multiple sclerosis drug. The case is reportedly pending before the Supreme Court.

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Teva Pharmaceutical Industries Ltd, US Food and Drug Administration, Mylan Inc, Novartis AG, Sandoz, generic Copaxone

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