US5846966 is listed in the Orange Book for ezetimibe (Zetia) and ezetimibe + simvastatin (Vytorin). It has been granted a six month pediatric extension for both Zetia and Vytorin and now expires March 21 2014.
由上可知US5846966并不是你说的1993.09.21到期。【1993.09.21到期,从逻辑上也说不通啊,你是不是搞错了?!是不是2013.09.21??】
USRE37721 (orignally US5767115) is listed in the Orange Book for ezetimibe (Zetia) and ezetimibe + simvastatin (Vytorin). It has been granted a 497 day extension for ezetimibe, which was limited to 14 years from approval and so expires October 25, 2016. This extension presumably coves both Zetia and Vytorin as a six month pediatric extension has been granted for both, with USRE37721 now expiring April 25 2017 according to the Orange Book.
Under § 156, the term of a patent that claims a drug product, a method of using a drug product, or a method of manufacturing a drug product may be extended by up to five years if the drug product was subject to FDA regulatory review prior to its commercial marketing or use.
Under § 156, the term of a patent that claims a drug product, a method of using a drug product, or a method of manufacturing a drug product may be extended by up to five years if the drug product was subject to FDA regulatory review prior to its commercial marketing or use.