Watson Pharmaceuticals Inc. (WPI) recently announced that it has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) to market its generic version of Pfizer Inc.’s (PFE) erectile dysfunction (ED) drug, Viagra sildenafil citrate tablets.
In response, Pfizer has filed a lawsuit against Watson Pharma in the United States District Court for the Southern District of New York. Since Pfizer 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. Viagra sales amounted to $1.9 billion in 2010.
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 dosage strengths of the authorized generic of Amrix to Watson Pharma, who in turn markets the product in the US. For the deal, Watson Pharma will receive sales-based payments.
Additionally, the company has an agreement with Johnson & Johnson, under which the latter manufactures and supplies all dosage strengths of the authorized generic of Concerta to Watson Pharma, who distributes the product in the US.
According to the agreement, which runs through 2014, Johnson & Johnson is set to receive a share of the net sales of the product from Watson Pharma.
The agreement allows Watson Pharma to file an ANDA with the FDA in order to launch its own generic version of Concerta, post the conclusion of the current agreement.
Our View
We currently have a Zacks #2 Rank (short-term Buy rating) on Watson Pharma. 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. First quarter Global Generics sales amounted to $600.0 million, representing a year-over-year increase of 10%.
Longer term, we have a Neutral recommendation on the company.
CEPHALON INC (CEPH): Free Stock Analysis Report
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WATSON PHARMA (WPI): Free Stock Analysis Report
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