Watson to Market Generic Lybrel - Analyst Blog
June 08 2011 - 5:45AM
Zacks
Watson Pharmaceuticals Inc. (WPI) recently
announced that the US Food and Drug Administration (FDA) approved
the company’s generic version of Pfizer Inc.’s
(PFE) oral contraceptive Lybrel. Watson Pharma plans to launch the
generic drug, levonorgestrel and ethinyl estradiol tablets, USP,
0.09 mg/0.02 mg, in the near future.
According to IMS health, Lybrel sales amounted to $12 million
for the twelve months ended April 30, 2011.
Last week, Watson Pharma announced the filing of an Abbreviated
New Drug Application (ANDA) with the FDA to market its generic
version of Pfizer’s erectile dysfunction (ED) drug, Viagra
(sildenafil citrate) tablets.
In response, Pfizer filed a lawsuit against Watson Pharma in the
United States District Court for the Southern District of New York.
Since Pfizer has filed a suit within 30 days of the ANDA filing,
the FDA cannot approve Watson Pharma’s generic Viagra until
November 6, 2013 or until the court ruling, whichever is
earlier.
Watson Pharma is seeking approval for the 25 mg, 50 mg and 100
mg dosage formulations of sildenafil citrate tablets.
Moreover, last month, Watson Pharma launched the authorized
generic of Cephalon Inc.’s (CEPH) Amrix (15 mg and
30 mg) and Johnson & Johnson’s (JNJ) Concerta
in the US.
While Amrix is used to help control muscle spasm associated with
acute, painful musculoskeletal conditions, Concerta is a treatment
for attention deficit hyperactivity disorder (ADHD) in children
aged 6 to 17 and adults aged 18 to 65.
Watson Pharma has an agreement with Anesta (a subsidiary of
Cephalon), under which Anesta manufactures and supplies all the
dosage strengths of the authorized generic of Amrix to Watson
Pharma, which, in turn, markets the product in the US. For the
deal, Watson Pharma receives sales-based payments.
Additionally, the company has an agreement with Johnson &
Johnson, under which the latter manufactures and supplies all the
dosage strengths of the authorized generic of Concerta to Watson
Pharma, which distributes the product in the US.
Our View
We currently have a Neutral recommendation on Watson Pharma,
which carries a Zacks #3 Rank (short-term Hold rating). We expect
new generic product launches over regular intervals to help drive
the company’s Global Generic segment’s sales, which are expected in
the range of $2.9 billion to $3.1 billion in 2011. The first
quarter 2011 Global Generics sales amounted to $600.0 million,
representing a year-over-year increase of 10%.
CEPHALON INC (CEPH): Free Stock Analysis Report
JOHNSON & JOHNS (JNJ): Free Stock Analysis Report
PFIZER INC (PFE): Free Stock Analysis Report
WATSON PHARMA (WPI): Free Stock Analysis Report
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