Nexium (esomeprazole) for gastroesophageal reflux disease
generated sales of approximately $2.9 billion in the first nine
months of 2013, accounting for approximately 15.2% of
) total revenues. However, the company expects Nexium sales to
decline from 2014 onwards due to generic competition. We remind
investors that AstraZeneca is entangled in patent litigation
related to Nexium with several generic companies including
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Additionally, the U.S. Court of Appeals for the Federal Circuit
(CAFC) has lifted the temporary injunction against the U.S.
launch of Hanmi Pharmaceutical's esomeprazole strontium. After
which the company has launched the drug. Esomeprazole strontium
was approved by the U.S. Food and Drug Administration (FDA) in
We remind investors that in Jun 2013 AstraZeneca had entered into
an agreement with Hanmi Pharma and Amneal Pharmaceuticals (the
U.S. marketing partner of Hanmi Pharma), to resolve patent issues
related to AstraZeneca's Nexium involving esomeprazole strontium.
As per the terms of the agreement, Amneal Pharma and Hanmi Pharma
accepted that two of AstraZeneca's patents (5,714,504 and
5,877,192) protecting Nexium in the U.S. are valid. The consent
judgment provides that Hanmi's esomeprazole strontium product
does not infringe these patents based on the District Court's
claim construction issued in Dec 12, 2012.
AstraZeneca filed a Notice of Appeal in the U.S. Court of Appeals
for the Federal Circuit seeking reversal of critical aspects of
the district court's Dec 2012 construction.
We believe the sooner-than-expected entry of generics and similar
products will put additional pressure given that the company is
already witnessing plunging revenues due to generic competition
for several key drugs including Seroquel.
AstraZeneca carries a Zacks Rank #3 (Hold). Some better-ranked
Vanda Pharmaceuticals, Inc.
). Both carry a Zacks Rank #1 (Strong Buy).