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.