Teva Launches Generic Lexapro - Analyst Blog
March 15 2012 - 4:15AM
Zacks
Teva Pharmaceutical
Industries Ltd. (TEVA) recently announced that it has
launched its generic version of Forest
Laboratories’ (FRX) Lexapro. Teva will enjoy six months of
marketing exclusivity as it was the first generic company to have
filed an Abbreviated New Drug Application (ANDA) for Lexapro with a
paragraph IV challenge.
Lexapro has been a major revenue
generator for Forest Labs with the product generating sales of $1.8
billion in the first nine months of fiscal 2012. Besides Teva’s
generic version, Mylan’s (MYL) authorized generic
version of Lexapro is available in the market.
Mylan had announced the launch of
its authorized generic version in late February 2011. According to
its settlement agreement with Forest Labs, Mylan will market its
product until the compound patent loses pediatric exclusivity.
Lexapro is indicated for the acute
and maintenance treatment of major depressive disorder (MDD) and
acute treatment of generalized anxiety disorder. Lexapro sales will
be impacted significantly with the entry of Teva’s generic version.
The product accounted for 55% of Forest Labs’ total sales in fiscal
2011.
Another key product, Namenda, in
Forest Labs’ portfolio could start facing generic competition in
early 2015. To reduce the impact of genericization, Forest Labs has
been working on developing its pipeline. The company has two
important FDA action dates coming up in the second quarter of 2012.
While linaclotide (partnered with Ironwood
Pharmaceuticals (IRWD)) is under review for the treatment
of constipation-predominant irritable bowel syndrome and chronic
constipation, aclidinium (partnered with Almirall) is under
regulatory review for chronic obstructive pulmonary disease
(COPD).
Meanwhile, the company expects to
file two more new drug applications (NDAs) in the second half of
2012 (levomilnacipran and cariprazine).
We currently have Neutral
recommendations on Forest Labs as well as Teva. Both companies
carry a Zacks #3 Rank (short-term “Hold’’ rating).
FOREST LABS A (FRX): Free Stock Analysis Report
IRONWOOD PHARMA (IRWD): Free Stock Analysis Report
MYLAN INC (MYL): Free Stock Analysis Report
TEVA PHARM ADR (TEVA): Free Stock Analysis Report
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