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FDA again delays decision on Copaxone patent

The decision gives Teva more time to transfer patients to its better patent protected double dosage Copaxone.


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Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) has filed a petition at the US Food and Drug Administration (FDA) seven times, asking the FDA not to approve a generic version of Copaxone, Teva’s flagship product for treatment of multiple sclerosis. Its petition has been turned down seven times. The most recent rejection was at the end of last week, when the FDA wrote again that a hearing on the matter would be premature. The FDA noted that the trial had not been completed, and the issues that Teva raised would be raised at a hearing if and when a generic version of Copaxone is approved.

Ostensibly, this rejection is a negative development for Teva, because its contentions were not accepted. Actually, however, the FDA again decided not to decide. The actual meaning is positive for Teva, because consideration by the FDA usually takes a lot of time, and any additional time enables Teva to transfer more and more patients to the new patent protected double-dosage version of Copaxone.

Copaxone is Teva’s most widely sold and profitable drug with US sales totaling $2.3 billion so far in 2014 (in both dosages). In its most recent citizen’s petition, Teva gave the FDA figures for gene expression following the use of Copaxone, and alleged that there was significant risk of difference in gene expression between the use of Copaxone and the use of generic products.

Teva is also struggling against the possibility of a generic version of Copaxone in the courts, where the issue is currently being heard by the US Supreme Court, which is considering the validity of the patent. A ruling on the matter is expected in the coming months.

Managed by CEO Erez Vigodman, Teva is traded on the New York Stock Exchange at a market cap of $48.7 billion.

Published by Globes [online], Israel business news –



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