AstraZeneca PLC
8 September 2000
AstraZeneca files lawsuit against Mylan
AstraZeneca today announced that it has filed a lawsuit in New York against
Mylan Laboratories Inc. and Mylan Pharmaceuticals Inc. (Mylan) for patent
infringement.
The lawsuit is the result of an Abbreviated New Drug Application (ANDA) filed
by Mylan with the Food and Drug Administration (FDA) concerning its intent to
market a generic omeprazole product in the US. The antisecretory drug
omeprazole is marketed in the US by AstraZeneca, L.P. under the brand name
Prilosec and is marketed internationally by AstraZeneca as Losec.
The basis for AstraZeneca's complaint is that the action by Mylan infringes
upon several patents relating to Prilosec, which provide protection to the
year 2014. These patents include coverage for formulations and for methods of
using Prilosec. The substance patent, which expires in 2001, has not been
challenged by Mylan.
AstraZeneca intends to fully enforce its patent rights and is steadfast in its
belief that all of the patents are valid.
Further enquires to:
Michael Olsson: Tel. +44 (0)20 7304 5087
Ed Seage: Tel. +1 302 886 4065
Jorgen Winroth: Tel. +1 609 896 4148
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