) recently received some positive news when the Court of Appeals
for the Federal Circuit maintained an earlier ruling that the US
substance patent (RE37, 314) related to Crestor (rosuvastatin
calcium) is valid. The '314 patent is set to expire in 2016,
until which no generic version of Crestor will be approved by the
US Food and Drug Administration (FDA).
Several generic drug makers including Apotex, Aurobindo, Cobalt,
), Sandoz, the generic arm of
) and Torrent had submitted Abbreviated New Drug Applications
(ANDAs) seeking approval for their generic versions of Crestor.
These companies can now approach the US Supreme Court for
Crestor is the lead revenue grosser at AstraZeneca. It currently
faces stiff competition given the presence of
) Zocor/Vytorin and generic versions of
Meanwhile, several products in AstraZeneca's portfolio are
already facing or are likely to face generic competition. In
2011, the company lost revenues worth almost $2 billion, to
generic competition. The weak late-stage pipeline coupled with
the slow Brilinta uptake also bothers us.
In such a scenario, we feel additional competition in the form of
Crestor generic would have hit the top-line significantly. We
believe that the court ruling in favor of AstraZeneca removes the
uncertainty regarding entry of generics and is a positive for the
Currently, we have a Neutral stance on AstraZeneca in the long
run. The stock carries a Zacks #3 Rank (Hold) in the short run.
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