According to Shire, the application filed by Corepharma for 100mg, 200mg and 300mg versions of the product infringe two patents that have not yet expired.
Meanwhile, the FDA has extended by 90 days the review period for Shire’s biologics license application (BLA) for Elaprase, the company’s treatment for Hunter syndrome.
This extension will allow the FDA additional time to review data and analyses that it requested during recent label discussions. The FDA has advised Shire that the new action date for the application is August 24, 2006.
The US BLA for Elaprase was submitted in November 2005 and was granted priority review, requiring the FDA to take action within six months. A marketing authorization application for Elaprase has also been submitted to the European Medicines Agency, and Shire expects a response on that application before the end of the year.