AstraZeneca sues Mylan after Faslodex generic bid
AstraZeneca has sued Mylan for allegedly infringing its patents covering the drug Faslodex (fulvestrant).
The complaint, filed at the US District Court for the District of Delaware on August 5, was made after Mylan sought approval from the US Food and Drug Administration to produce a generic version of the breast cancer treatment drug.
The Abbreviated New Drug Application was filed before the expiration of the patents in suit, US numbers 6,774,122; 7,456,160, and 8,329,680.
Mylan notified AstraZeneca that it was seeking approval to manufacture the proposed drug on June 27.
In its notice, Mylan claimed that the patents were invalid and unenforceable and therefore would not be infringed by its proposed generic.
Already registered?
Login to your account
If you don't have a login or your access has expired, you will need to purchase a subscription to gain access to this article, including all our online content.
For more information on individual annual subscriptions for full paid access and corporate subscription options please contact us.
To request a FREE 2-week trial subscription, please signup.
NOTE - this can take up to 48hrs to be approved.
For multi-user price options, or to check if your company has an existing subscription that we can add you to for FREE, please email Adrian Tapping at atapping@newtonmedia.co.uk