) announced that it has amended its abbreviated new drug
application (ANDA) for its generic version of
) 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
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
) currently look better positioned with a Zacks Rank #2 (Buy).
), 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
ACTAVIS INC (ACT): Free Stock Analysis Report
MYLAN INC (MYL): Free Stock Analysis Report
NOVARTIS AG-ADR (NVS): Free Stock Analysis
PERNIX THERAPTC (PTX): Free Stock Analysis
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