Actavis, Inc. announced that it has amended its abbreviated new drug application (ANDA) for its generic version of Novartis’ (NVS - Free Report) Exelon Patch (rivastigmine transdermal system). The company amended its ANDA so as to include the 13.3 mg/24 hours dosage strength of Exelon Patch. Actavis’ initial ANDA was for the 4.6 mg/24 hour and 9.5 mg/24 hour dosages.
Novartis has filed a patent infringement lawsuit against Actavis in the US District Court for the District of Delaware. The filing of the lawsuit within the stipulated time period under the Hatch-Waxman Act ensures that the FDA cannot grant final approval to Actavis’ generic for up to 30 months or the court’s decision, whichever is earlier.
We note that a separate lawsuit was filed by Novartis for the earlier ANDA in Nov 2011. Exelon Patch is approved for the treatment of mild to moderate dementia associated with Alzheimer's or Parkinson's disease.
Actavis believes it may be the first-to-file an ANDA for a generic version of Exelon Patch – if this is the case, Actavis would be entitled to 180 days of exclusivity on gaining FDA approval for its candidate. As per IMS Health data, Exelon Patch sales in the US were $521 million for the twelve months ended Jan 31, 2013.
Actavis is the third largest player in the global generics market and has a presence in more than 60 countries. As of Dec 31, 2012, the company had more than 185 ANDAs pending FDA approval. These include 49 first-to-file opportunities of which 33 could be exclusive first-to-files.
Actavis currently carries a Zacks Rank #4 (Sell). Other generic players like Mylan (MYL - Free Report) currently look better positioned with a Zacks Rank #2 (Buy). Pernix Therapeutics , a specialty pharma company focused on the development, selling and manufacturing of branded as well as generic and over-the-counter pharma products, is also a Zacks Rank #2 stock.