Forest Laboratories, Inc.
) 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.,
), 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
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
Currently, companies like
) with a Zacks Rank #1 (Strong Buy) and
) with a Zacks Rank #2 (Buy) look well-positioned.
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