) recently announced that it has launched its generic version of
Noven Therapeutics' Lithobid (lithium carbonate) extended release
450 mg tablets after receiving final approval from the US Food and
Drug Administration (FDA).
Lithobid is approved for manic episodes associated with manic
depressive illness. According to IMS Health, lithium carbonate
tablets, 450 mg, generated US revenues of approximately $15.2
million for the 12 months ending June 30, 2012.
Earlier this year, Mylan had received FDA approval for its
generic version of Lithobid extended-release 300 mg tablets. The
drug is approved as a maintenance therapy for bipolar disorder
patients in order to reduce the frequency and intensity of manic
episodes. Mylan started shipments of the drug for the said
In addition to launching its generic version of Lithobid,
Mylan's generic version of
) Provigil (modafinil - 100 mg and 200 mg), was approved by the
FDA. Provigil is approved for improving wakefulness in adult
patients with excessive sleepiness associated with narcolepsy,
obstructive sleep apnea/hyponea syndrome and shift work sleep
In June this year, Mylan had resolved all disputes with Teva
regarding the litigation filed by the former in the District of
Columbia federal court against the FDA concerning the company's
ANDA for modafinil tablets. We note that Teva alone was entitled to
the180-day exclusivity of generic Provigil as it was the
As per the terms of the agreement with Teva, Mylan was granted
permission for the launch of its generic version before the
expiration of Teva's 180-day marketing exclusivity period.
Par Pharmaceutical Companies Inc.
) also markets the generic version of Teva's Provigil in the
According to IMS Health data, modafinil tablets 100mg and 200 mg
generated US revenues of approximately $1.3 billion for the 12
months ending June 30, 2012.
As of August 10, 2012, Mylan had 166 ANDAs pending FDA
clearance, targeting $78.4 billion in branded sales annually. Mylan
believes that about 35 of these pending ANDAs are first-to-file
opportunities, representing approximately $25.1 billion in branded
sales. The revenue figures are as per IMS Health for the 12 months
ending December 31, 2011.
We are encouraged by Mylan's geographic reach and product depth
along with a robust generic product pipeline. However, we remain
concerned about the company's lackluster performance in the Europe,
Middle East and Africa (EMEA) region. Additionally, with most large
branded drugs 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.
Thus, we prefer to remain on the sidelines and have a Neutral
recommendation on Mylan. The stock carries a Zacks #2 Rank (Buy
rating) in the short term.
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