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Topamax gains extra time in US, but birth defect study a risk

This article was originally published in Scrip

Executive Summary

Johnson & Johnson's Ortho-McNeilunit has gained nearly an extra year of US marketing exclusivity on its top-selling epilepsy drug, Topamax (topiramate), as the FDA granted paediatric exclusivity, extending the patent expiry to March 2009 from September 2008. Earlier this year, a US federal appeals court upheld the compound patent, preventing generic competition.

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