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  • frankposting frankposting Mar 15, 2012 1:46 PM Flag

    Bystolic Patent Fight

    FRX launched patent fight on Bystolic, against 4 ANDA-filers with Paragraph IV certisfications, on 3/14/2012.

    The case is on the 6545040 patent (expiring 12/17/2021) -- a Use Patent expanded from the Product Patent 5759580 (expiring 6/2/2015). BTW, the NCE exculsivity granted by FDA will be expired on 12/17/2012.

    In according with FDA's rlues, the lawsuit triggers a 30-month stay. I.e., FDA won't approve any generic Bystolic before 9/14/2014. Usually, FDA will grant tentative approval(s) around that date, and the court would output its judgement around 9/14/2014.

    The date, 9/14/2014, is a bit early, in consideration of the Namenda cliff on February, 2015.

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    • FDA's website shows the first ANDA for generic Bystolic was accepted on 12/19/11. In 3/14/12 PR, FRX is fighting with 4 ANDAs. Bystolic just a pill without any other tricks, thus many new ANDAs will fellow. And, if FRX cannot hold the 040 patent, then nothing to stop the flood of generics on the date of 9/14/14. I.e., Byslotic cliff may be ahead of Namenda cliff. BTW, Bystolic is the only product having the potential of $1B peak sales in the future for FRX (but the genercization may wake up the dreamer).

      • 2 Replies to frankposting
      • The origin of Bystolic:

        Mylan Laboratories and Forest Laboratories Announce Nebivolol Licensing Agreement
        Category: Product News
        Wednesday, January 11, 2006 8:08 am EST
        EmailPDFPrintRSSShareThisPublic Company Information:
        NYSE:FRX.Mylan Laboratories Inc. (NYSE: MYL) and Forest Laboratories Holdings, Ltd., a wholly owned subsidiary of Forest Laboratories, Inc. (NYSE: FRX) announced today that the two companies have entered into an agreement for the commercialization, development and distribution of Mylan's novel beta blocker nebivolol in the United States and Canada.

        Under the terms of the agreement, Forest will make an upfront payment to Mylan of $75 million as well as potential future milestone payments. In addition, Mylan will also receive royalty payments based on nebivolol sales. Forest will assume all nebivolol development expenses for current and future development programs. Forest will be responsible for all sales and marketing expenses and Mylan has retained an option to co-promote the product in the future.

        Robert J. Coury, Vice Chairman and Chief Executive Officer of Mylan, commented: "We view Forest as an ideal partner for nebivolol. They meet all of the criteria that we previously described, including impressive expertise in the cardiovascular market, a proven track record in launching major branded products and a commitment to invest in the research and development necessary to maximize the full commercial potential of nebivolol."

        Howard Solomon, Chairman and Chief Executive Officer of Forest, said: "We are excited about the opportunity to market nebivolol, a highly beta-1 selective beta blocker which, based on the Phase III studies included in the NDA filed by Mylan, appears to have favorable differentiating characteristics. We are also particularly pleased to be partnering with Mylan and look forward to a long-term collaboration with this excellent company."

        On May 31, 2005, Mylan received an approvable letter from the U.S. Food and Drug Administration (FDA) on its New Drug Application (NDA) for nebivolol for the treatment of hypertension. Final approval is contingent upon successfully satisfying additional FDA requirements included in the approvable letter. Mylan has completed a pre-clinical study designed to address certain questions posed by the FDA and is working towards submitting the results and other information to the FDA for their review.

        In addition, Mylan intends to submit a separate nebivolol NDA to the FDA for the treatment of congestive heart failure. The submission, anticipated to occur sometime during the second half of calendar year 2006, will be based on data from the SENIORS clinical study conducted in Europe by the Menarini Group.

        About Nebivolol

        Nebivolol is a novel beta blocker that is already approved and marketed in more than 65 countries outside of North America. Mylan licensed the U.S. and Canadian rights to nebivolol from Janssen Pharmaceutica N.V. in 2001, and has obtained Janssen's consent to sub-license nebivolol to Forest Laboratories in those territories. Nebivolol is a highly-beta-1 selective beta-blocker, an attribute which may provide certain advantages compared to currently marketed beta blockers. Upon FDA approval Nebivolol will receive five years of marketing exclusivity under the Hatch Waxman legislation. In addition there is an issued U.S. pharmaceutical composition of matter patent set to expire in 2020 which may offer additional exclusivity.

      • FRX's $375M Bystolic move is a wise bet. But the key is the patent fight. The Product Patent and the Use Patent are defendable, thought both rae weak. Patent fight is always to be an individual case -- pending on the judge. If FRX loses the case, they may lose a part of the premiun; if they win, they will build another blockbuster to fill a corner of the ongoing patent-cliff.