% | $
Quotes you view appear here for quick access.

FRX Message Board

you are viewing a single comment's thread.

view the rest of the posts
  • frankposting frankposting Oct 28, 2012 4:45 PM Flag

    Bystolic Cliff Is Coming Sooner Than Namenda Cliff

    Let me provide more info:

    1) The first-to-file:
    East Brunswick NJ, USA, March 15 th, 2012 – Amerigen Pharmaceuticals Limited today confirmed that its subsidiary Amerigen Pharmaceuticals Inc. has filed an Abbreviated New Drug Application (“ANDA”) containing a paragraph IV certification for a generic version of BYSTOLIC® with the US Food & Drug Administration (“FDA”) and is seeking approval to market its nebivolol hydrochloride tablets prior to expiration of U.S. Patent 6,545,040.

    On March 13th 2012, Forest Laboratories and Janssen Pharmaceutica filed suit for patent infringement against Amerigen in the District of Delaware.

    Based upon available information, Amerigen believes that it may be a first applicant to file an ANDA for a generic version of BYSTOLIC® containing a Paragraph IV certification under the provisions of the Hatch-Waxman Act. Should its ANDA for nebivolol hydrochloride tablets be approved by the FDA, Amerigen believes that its product may be entitled to 180 days of generic marketing exclusivity.

    For the twelve months ending December 31st, 2011, Forest reported US net sales of BYSTOLIC® of approximately $324MM.

    BYSTOLIC® is a beta-adrenergic blocking agent indicated for the treatment of hypertension, to lower blood pressure.

    2) In accord with FDA's rules, if a first-to-file-generic-drug-maker received final approval, they have to launch the product within 75 days, otherwise they will lose the 180-day exclusivity -- i.e., greatly cutting the profitability.
    Seems that Oct 26 PR was intentional to be fuzzy about the date.

    SortNewest  |  Oldest  |  Most Replied Expand all replies