) recently announced that it has launched its generic version of
Lupin Atlantis Holdings, S.A.'s Antara capsules (fenofibrate - 43
mg and 130 mg). The company started shipping the product
following the receipt of final US Food and Drug Administration
Antara is approved as an adjunct to diet to reduce elevated
LDL-C, total-C, triglycerides, and Apo B. It is also indicated to
increase HDL-C in adults with primary hypercholesterolemia or
mixed dyslipidemia and to reduce triglyceride (TG) levels in
patients with severe hypertriglyceridemia. Fenofibrate
capsules generated US revenues of approximately $60 million for
the 12 months ending Sep 30, 2012, as per data released by IMS
As of Feb 25, 2012, Mylan had 184 abbreviated new drug
applications (ANDAs) pending FDA clearance, targeting $80.7
billion in sales annually. Mylan believes that about 36 of these
pending ANDAs are first-to-file opportunities, representing $21.1
billion in branded sales. The revenue figures are as per IMS
Health for the 12 months ending June 30, 2012.
In Jan 2013, Mylan announced that it received final approval
from the FDA TO market its generic versions of
Merck & Co. Inc.
) Maxalt MLT and Maxalt tablets. They are indicated for the acute
treatment of migraine with or without aura in adults.
Mylan's geographic reach and robust generic product portfolio are
contributing to the company's overall growth. Additionally,
Mylan's impressive generic pipeline is also encouraging.
However, we remain cautious of the company's performance in the
Europe, Middle East and Africa (EMEA) region.
Furthermore, as most of the large branded drugs are due to lose
patent exclusivity within the 2017-2018 period, we have little
visibility on the growth prospects of generic companies like
Mylan beyond that timeframe.
Mylan carries a Zacks Rank #2 (Buy). Currently, pharma
Lannett Company, Inc.
United Therapeutics Corporation
) look more attractive with a Zacks Rank #1 (Strong Buy).
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