) gained 1.18% following a favorable ruling by the U.S. district
court on a patent related case pertaining to
Pharmaceutical Industries Ltd.
) multiple sclerosis (MS) drug Copaxone 20mg/mL. The U.S. Orange
Book patent covering Copaxone is set to expire in May 2014 and
worldwide in May 2015.
Copaxone generated approximately $4.3 billion in worldwide sales in
2013, accounting for more than 21% of Teva's total revenues. U.S.
sales were $3.2 billion in 2013. Worldwide Copaxone revenues edged
up 1% to $1.07 billion in the first quarter of 2014. Sales in the
U.S. grew 1% to $816 million benefiting from a January price
By dismissing Teva's suit against the U.S. Food and Drug
Administration (FDA), the court has foiled the former's attempt to
delay the release of generic versions of Copaxone. Teva had argued
that more testing was needed for the cheaper formulations of the MS
drug. We note that Mylan had intervened in this suit and supported
the U.S. regulatory body.
The court ruling removes any hurdle for the FDA from approving
generic versions of the drug following its patent expiry. Several
generic companies including
Momenta Pharmaceuticals, Inc.
)/Sandoz Inc., a subsidiary of
) and Mylan /Natco Pharmaceuticals are looking to get their generic
versions of Copaxone in the market.
In the event of Mylan launching its generic version of the drug,
its generic segment would be boosted significantly. In the first
quarter of 2014, third-party net sales in the generic division
climbed 7.1% to $1.51 billion driven by strong performance in North
We expect the generic segment to continue performing well. Mylan's
focus on emerging markets is encouraging. Emerging markets are
slowly and steadily gaining more importance and several companies
are now shifting their focus to these areas.
Mylan carries a Zacks Rank #3 (Hold).
) is an example of a better-ranked stock in the health care space
with a Zacks Rank #1 (Strong Buy).
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