Generic drug makers,
), are gearing up to launch their generic versions of
) Celebrex (celecoxib). Earlier this week, the United States
District Court for the Eastern District of Virginia had ruled
that the reissue patent for the drug, which was to expire on Dec
2, 2015 (including 6 months pediatric exclusivity), is
This clears the path for companies like Actavis,
) and Mylan among others (Lupin and Apotex) to launch their
generic versions of Celebrex. Both Actavis and Mylan have issued
press releases saying they intend to launch their generic
versions of the drug in May 2014 provided the FDA grants final
approval to their abbreviated new drug applications.
Mylan said that it believes it has shared exclusivity for the
100 mg, 200 mg and 400 mg strengths. Celebrex, a non-steroidal
anti-inflammatory drug, is approved for the relief of the signs
and symptoms of osteoarthritis, rheumatoid arthritis, ankylosing
spondylitis, and for the management of acute pain in adults.
Celebrex sales in the U.S. were $2.2 billion in 2013.
The entry of generic Celebrex, if launched in May 2014, would
be a full 18 months before expected. Pfizer has been trying to
block the entry of generics in May and intends to appeal the
court ruling regarding the reissue patent.
Pfizer is already facing generic competition for several
products in its portfolio including Lipitor, Norvasc and Zoloft.
Additional patent expiries are expected in the coming years. The
loss of patent exclusivity on blockbuster products will make it
challenging for Pfizer to drive top-line growth. Pfizer, which
currently expects earnings of $2.20 - $2.30 per share on total
revenues of $49.2 billion - $51.2 billion in 2014 will most
likely have to adjust its guidance if generic versions of
Celebrex enter the market this year.
While Pfizer is a Zacks Rank #3 (Hold) stock, Actavis, Mylan
and Teva are all better-ranked with all three being Zacks Rank #2
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