Forest Laboratories, Inc. (FRX) is facing a series of patent challenges for some of its products. The company is looking to protect these products from generic competition by filing patent infringement lawsuits.
At present, Forest Labs is facing patent challenges for its hypertension treatment, Bystolic, and Savella (management of fibromyalgia). The company has filed patent infringement lawsuits against several companies looking to bring generic versions of Savella to market. The patent challengers include companies like Apotex Corp., Hetero USA Inc., Lupin Ltd., Mylan (MYL), Par Pharmaceuticals, Inc., Ranbaxy Laboratories Ltd., and related companies and subsidiaries.
An additional patent infringement lawsuit was filed by Forest Labs last week against First Time US Generics LLC. The filing of the lawsuits within the stipulated time period under the Hatch-Waxman Act ensures that the FDA cannot grant final approval to the generic versions of Savella for up to 30 months or the court’s decision, whichever is earlier.
Meanwhile, as far as Bystolic is concerned, Forest Labs has entered into settlement agreements with five of the seven defendant groups in the patent infringement litigation. Forest Labs is currently looking to drive Bystolic's growth by providing additional data on the appropriate use of the product. The company is also working on extending the product’s lifecycle by bringing a fixed dose combination of Bystolic and valsartan for hypertension to market. Forest Labs reported positive phase III results on this combination and expects to file for approval in the first quarter of calendar 2014. A fixed dose combination product would expand the patient population for Bystolic. Approval as a first-line treatment would also boost sales significantly.
Forest Labs currently carries a Zacks Rank #3 (Hold). With Namenda slated to face generic competition from early 2015 putting $1+ billion at risk, new product launches need to be successful.
Currently, companies like Ironwood Pharmaceuticals (IRWD) with a Zacks Rank #1 (Strong Buy) and Aradigm Corporation (ARDM) with a Zacks Rank #2 (Buy) look well-positioned.
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