) recently entered into a settlement agreement with
) regarding their patent litigation for Crestor. Actavis was
looking to launch its generic versions of Crestor (rosuvastatin
calcium) tablets (5, 10, 20 and 40 mg). The settlement agreement
also covers Actavis' rosuvastatin zinc salt product.
Crestor is slated to lose exclusivity in the US on Jul 8, 2016
(including pediatric exclusivity). As per the terms of the
agreement, Actavis may launch its generic version of Crestor 67
days before Crestor loses exclusivity on paying 39% of net sales
However, the launch of the generic version of Crestor depends
on the final approval from the US Food and Drug Administration
(FDA). In Jun 2011, the FDA granted tentative approval to
Actavis' Abbreviated New Drug Application (ANDA) for Crestor.
The deal also allows Actavis to launch its rosuvastatin zinc
alternate salt product on or before May 2, 2016, which will not
be a generic substitute for Crestor. The company is, however,
undecided on the potential launch of the product. Actavis and
AstraZeneca have kept the other terms of the agreement under
We believe that the resolution of the dispute is a positive
for AstraZeneca and removes a major overhang on its shares.
Crestor is approved for cholesterol management. AstraZeneca
recorded Crestor sales of $1.6 billion in 2012, down 8.4% from
Earlier this month, AstraZeneca announced that three patents
protecting Crestor were rendered invalid by the Federal Court of
Australia. The three patents including a formulation patent were
set to expire by 2020-21. The patents were challenged by
companies like Apotex, Ascent Pharma and Actavis. Crestor is
already facing generic erosion in Canada.
Actavis currently carries a Zacks Rank #3 (Hold). Other
generic players such as
Lannett Company Inc.
) currently look better positioned. While Lannett carries a Zacks
Rank #1 (Strong Buy), Mylan carries a Zacks Rank #2 (Buy).
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