) recently filed a patent infringement lawsuit against
) which is looking to launch a generic version of Santarus'
Fenoglide (fenofibrate - 40 mg and 120 mg) tablets. The two
listed patents are scheduled to expire in 2024.
Santarus has an exclusive license agreement with Cowen
Healthcare Royalty Partners and Shore Therapeutics, Inc. for the
commercialization of Fenoglide in the US. Fenoglide is indicated
to treat adults with hyperlipidemia, mixed dyslipidemia and
Fenoglide revenues for the nine months ending Sep 30, 2012
were $5.6 million.
The filing of the patent infringement lawsuit within 45 days
from the date of receipt of notice from Mylan is in line with our
expectations. This will ensure that the FDA cannot grant final
approval to Mylan's generic for up to 30 months or the court's
decision, whichever is earlier.
We note that another generic company, Impax Laboratories
(IPXL) had also challenged the Fenoglide patent. However, Shore
Therapeutics had signed a settlement agreement with Impax
regarding the patent infringement litigation. Under the terms of
the agreement, Impax was granted a sub-license under which it can
start selling its generic version of Fenoglide on Oct 1, 2015 or
earlier under some circumstances.
With Fenoglide not being a major contributor to the top-line,
we do not expect the news regarding the patent infringement
lawsuit to have a major impact on Santarus' shares.
In fact, we expect investor focus to remain on the
commercialization of Uceris and the Zegerid re-launch. Earlier
this month, Santarus had gained FDA approval for Uceris for
remission in patients suffering from mild-to-moderate ulcerative
colitis. Uceris is likely to be launched in Mar 2013.
Santarus carries a Zacks Rank #4 (Sell) while Mylan carries a
Zacks Rank #2 (Buy). Right now,
Furiex Pharmaceuticals, Inc.
Valeant Pharmaceuticals International, Inc.
), look more attractive with a Zacks Rank #1 (Strong
FURIEX PHARMACT (FURX): Free Stock Analysis
MYLAN INC (MYL): Free Stock Analysis Report
SANTARUS INC (SNTS): Free Stock Analysis
VALEANT PHARMA (VRX): Free Stock Analysis
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