Teva Pharmaceutical Industries Ltd.
) announced that the Chief Justice of the U.S. denied its appeal
of a decision from the U.S. Court of Appeals for the Federal
Circuit that invalidated the claim of U.S. Patent 5,800,808
covering Teva's relapsing-remitting multiple sclerosis (RRMS)
product, Copaxone 20mg/mL. The company said that it will continue
pursuing its appeal in the Supreme Court.
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We remind investors that the '808 patent was invalidated by the
U.S. Court of Appeals for the Federal Circuit last year. 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 the company's total
revenues. U.S. sales were $3.2 billion in 2013. Teva has
undertaken several initiatives (including developing new
candidates targeting multiple sclerosis (MS) and a new
formulation of Copaxone) to mitigate the impact of
Earlier this year, Teva launched its three times-weekly (3TW)
formulation of Copaxone (40mg/mL) in the U.S. and is looking to
switch 30%−50% of Copaxone patients to the new formulation by
We note that several generic companies including
Momenta Pharmaceuticals, Inc.
)/Sandoz Inc. and
)/Natco Pharmaceuticals are looking to get marketing approval for
their generic versions of Copaxone. Mylan expects to gain
approval for its generic version by May 25 and expects to be the
first to launch a generic version of the product.
Meanwhile, Teva settled its patent infringement lawsuit with
) regarding its generic version of Pfizer's Celebrex (50, 100,
200 and 400 mg capsules) in the U.S. Teva, which has received
tentative FDA approval for its generic version of Celebrex, can
launch its generic Celebrex in the U.S. in or before Dec 2014.
According to IMS Health, Celebrex generated revenues of $2.2
billion in 2013.
We remind investors that Teva's guidance for 2014 includes two
scenarios: Copaxone remaining exclusive and Copaxone going
generic from Jun 1, 2014. The entry of Copaxone generics in 2014
could reduce total revenues by about $500 million and earnings by
60 cents. According to Teva, each month of delay in the entry of
generic versions of Copaxone will add $78 million to revenues and
8 cents to earnings.
The MS market is crowded with several approved drugs (injectables
and oral therapies) including Gilenya and Tecfidera.
Teva carries a Zacks Rank #2 (Buy). Momenta and Mylan also hold a
Zacks Rank #2.