WILMINGTON, Del., Sept. 23 DE-AstraZeneca-Court
WILMINGTON, Del., Sept. 23 /PRNewswire-FirstCall/ -- AstraZeneca today
announced that the US District Court for the District of New Jersey has denied
Teva's Motion for Summary Judgment of no infringement in the PULMICORT
RESPULES(R) (budesonide inhalation suspension) patent litigation.
The court also announced that a trial date will be scheduled and is likely
to be in January of 2009. AstraZeneca remains focused on preparing for this
trial and is confident in the strength of the intellectual property protecting
PULMICORT RESPULES.
In October of 2005, AstraZeneca announced that it had filed a lawsuit in
the US District Court for the District of New Jersey against IVAX
Pharmaceuticals, Inc. (now known as Teva Pharmaceutical Industries Ltd.) for
patent infringement. The lawsuit is the result of an abbreviated New Drug
Application (ANDA) filed by Teva with the US Food and Drug Administration
(FDA) concerning its intent to market a generic version of AstraZeneca's
PULMICORT RESPULES in the US prior to the expiration of AstraZeneca's patents
in 2018, with pediatric exclusivity extending to 2019.
The FDA has not approved a generic form of PULMICORT RESPULES, and has not
yet responded to AstraZeneca's Citizen Petition, filed in 2006. The Petition
outlined AstraZeneca's willingness to work with the FDA to ensure that any
follow-on budesonide inhalation suspension product is as safe and effective as
PULMICORT RESPULES.
About AstraZeneca
AstraZeneca is a major international healthcare business engaged in
research, development, manufacturing and marketing of prescription
pharmaceuticals and supplier for healthcare services. AstraZeneca is one of
the world's leading pharmaceutical companies with healthcare sales of US
$29.55 billion and is a leader in gastrointestinal, cardiovascular,
neuroscience, respiratory, oncology and infection product sales. AstraZeneca
is listed in the Dow Jones Sustainability Index (Global) as well as the
FTSE4Good Index.
SOURCE AstraZeneca