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FRX Message Board

  • frankposting frankposting Nov 14, 2012 5:12 PM Flag

    Son, Never Compete in a Field with Existing Generics!!!

    The above title is prepared for Howard to tell David.

    Forest Labs just announced that they are develop a fixed-dose-combination (FDC) of Namenda XR + Donepezil (active ingredient of Aricept). Donepezil has already been genericized by many small companies for a few years, and it is very cheap. Namenda XR was approved by FDA in June 2010, but FRX didn't launch it. FRX said they expect to launch Namenda XR in early 2013. However, the exclusivity of Namenda XR will expired in June 2013. So, it is very possible that Namenda XR will be genericized in mid-2015.

    Therefore, the proposed N+D FDC will compete with generic Namenda XR and generic Donepezil.

    FDC is a well-known strategy for pharmas. Usually, they keep one being common generic but another to be with IP, or two of them have novel interaction(s). Even though, most FDC just preformed so-so in the market. Both Namenda and Aricept are with weak efficacy. Interaction? I don't believe FRX can prove it -- in order to prove an interaction, a humongous study is needed. I believe FRX will do BE studies to apply for FDA's approval. The BE studies even cannot prove any additive efficacy by gathering two components.

    In light of difficulties of finding good and new product, I believe FRX will do FDC after FDC, but hard to make sizeable rewards.

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    • Home work? I am in the pharmaceutical sciences for about 20 years.

      FYI: Regarding the strength of patent, Chemistry Entity Patent is the strongest, Use Patent may be useful, and Formulation Patent is usually the weakest. Dozens formulation patents were defied by generic challengers in the court every year.

      Unfortunately, Namenda XR only has formulation patent.

      BTW, I have a thought of that FRX may never launch Namenda XR (even they said "will launch in early 2013"). They may directly chase the FDC of N + D. A Combination Patent could be better than a Formulation patent.

    • I think you need to do more homework around the importance of patents. Namenda XR is may lose regulatory exclusivity sooner, but the patent protection goes well beyond 2020.

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