Watson in an Upbeat Mood - Analyst Blog


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Watson Pharmaceuticals Inc. ( WPI ) was recently buoyed by the news that the United States Court of Appeals has granted a stay of the preliminary injunction, which was preventing Watson Pharma and partner Amphastar Pharmaceuticals Inc. from marketing a generic version of Sanofi 's ( SNY ) Lovenox. The companies plan to launch their generic drug immediately.

The US Food and Drug Administration (FDA) had approved Amphastar Pharma's abbreviated new drug application (ANDA) for generic Lovenox in September 2011. The regulatory body approved the 30mg/mL, 40mg/mL, 60mg/mL, 80mg/mL, 100mg/mL, 120mg/mL, 150mg/mL and 300mg/mL strengths of the generic version. We note Amphastar Pharma and Watson Pharma have an agreement, by virtue of which the latter has the exclusive right to distribute generic Lovenox in the US.

Enoxaparin is marketed worldwide as a prophylaxis and treatment for deep vein thrombosis and prophylaxis of ischemic complications in unstable angina and non-Q-wave myocardial infarction.

Additionally, Watson Pharma announced that it has reached a settlement with Mallinckrodt Inc. on a patent litigation related to Watson Pharma's generic version of Mallinckrodt's pain drug, Exalgo. According to the settlement agreement, Watson Pharma can launch its bioequivalent version of Exalgo on November 15, 2013. Mallinckrodt also granted Watson Pharma a royalty-free license to the US patents of the drug. 

We note that Mallinckrodt had filed its lawsuit against Watson Pharma in December 2010 in the United States District Court for the District of New Jersey, when Watson Pharma had filed an ANDA with the FDA seeking approval to market its generic version of Exalgo in the 8 mg, 12 mg and 16 mg formulations.

Watson Pharma believes that it may be the first to file an ANDA for the generic version of Exalgo, and if its application gets approved, it will be entitled to 180 days of generic market exclusivity.

We expect the new generic product launches over regular intervals to help drive the company's Global Generic segment's sales, which amounted to $3.36 billion in 2011, driven by the launch of generic versions of Pfizer 's ( PFE ) cholesterol drug Lipitor and Johnson & Johnson 's ( JNJ ) attention-deficit hyperactivity disorder (ADHD) drug Concerta.

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