US court dismisses Teva suit to block generic Copaxone

Bresch added, “Teva’s suit against the FDA was simply a desperate, last minute tactic, among others, to delay access to more affordable generic versions of Copaxone for patients in the US.”

Copaxone‘s US patents expire on May 24. Teva has appealed to the US Supreme Court over the expiry; the court will hear the case during its next session, which begins in October. Teva has sued the FDA for not yet deciding whether generic versions of Copaxone will require full clinical trials. It argues that there are substantive differences between brand Copaxone and generic versions of the drug, and has asked the FDA to require clinical trials, which could delay their entry to market by almost three years. The FDA has repeatedly declined to decide on the matter, although it has hinted that it will reject Teva’s request.

Published by Globes [online], Israel business news – www.globes-online.com 

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