Zacks_Analysts' Blog : Watson Files ANDAs - Analyst Blog

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 the generic version of Noven Pharmaceuticals Inc.'s drug Daytrana, and Pfizer Inc.’s (PFE) Embeda.

Daytrana is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) and Embeda is indicated for the management of moderate to severe pain when a continuous, around-the-clock, opioid analgesic is needed for an extended period of time.

In response, Noven has filed a lawsuit against Watson Pharma in the United States District Court of New Jersey and Pfizer filed a lawsuit in the United States District Court for the District of Delaware. Since both companies filed their lawsuits within 30 days of the ANDA filing, the FDA cannot approve Watson Pharma’s generic Daytrana and generic Embeda for up to 30 months from the date Noven and Pfizer received notice of the ANDA filing, respectively, or until the court ruling, whichever is earlier.

According to IMS Health, Daytrana sales amounted to $87 million for the twelve months ended July 31, 2011, and Embeda sales came in at $42 million for the twelve months ended August 31, 2011.

Last week, Watson Pharma also reported that on the request of Momenta Pharmaceuticals Inc. (MNTA) and Novartis AG (NVS), the United States District Court for the District of Massachusetts put a temporary restraining order (TRO) on Watson Pharma and Amphastar Pharmaceuticals Inc., thereby, preventing them from marketing a generic version of Sanofi-Aventis’ (SNY) Lovenox. While, a hearing for the preliminary injunction is scheduled for October 20, 2011, the TRO is expected to expire on October 21, 2011.

Watson Pharma plans to launch the generic drug in the US in the fourth quarter of 2011, if the request for a preliminary injunction is denied.

Lovenox is indicated for the prophylaxis and treatment of deep vein thrombosis and prophylaxis of ischemic complications in unstable angina and non-Q-wave myocardial infarction.

Watson Pharma has a distribution agreement with Amphastar, under which the latter will supply generic Lovenox to Watson Pharma, which will market, sell and distribute the product to US retail pharmacy channels. Amphastar will market, sell and distribute the product to all other channels, and receive 50-55% of Watson Pharma's gross profits on product sales.

We remind investors that on September 19, the FDA had approved Amphastar’s ANDA for the generic version of Lovenox, in the 30mg/mL, 40mg/mL, 60mg/mL, 80mg/mL, 100mg/mL, 120mg/mL, 150mg/mL and 300mg/mL strengths.

We expect new generic product launches over regular intervals to help drive Watson Pharma’s Global Generic segment’s sales.