With the FDA denial of the Citizens Petition to extend the patent on Duragesic, how long will it take Alza to get FDA approvals and ship next generation pain patch to customers?
Duragesic Patch has been a product with significant contributions to J&J sales and profits.
Well said Doc, my sources on the street confirm that JNJ has factored Duragesic numbers into their financials-their contingencies were in-place per this scenario. Your calm, clear, and rational discussion is greatly appreciated, as you have said many times before here this is why we own interest in such a healthy and diversified firm-Rick.
I stand corrected...James Burke...and his son is not President of Comcast...Steve Burke, no relation, is President under Brian Roberts. My source corrected himself this AM.
Lets keep more threads alive on this board!
Thank you for this insight oldrugdoc. I appreciate you taking the time to explain the patent issue. I will ask, before offering an opinion on something that I had not researched properly. I've just reviewed their "SELECTED PHARMACEUTICALS IN LATE STAGE U.S. DEVELOPMENT OR REGISTRATION" report (available at: http://www.investor.jnj.com/pharma-pipeline.cfm?textOnly=false ) and with the number of pharmaceuticals coming down the pipe, their future does look promising.
I still think that taking a hit against a 1.6B revenue stream will be a cause to pause, but only for the near term...as other drugs take over when they are brought on stream.
Thanks again for your patent explanation.
If you look at the loss of 1.6 BB in sales how much of that is profit? A lot of lost profit. Of course J&J won't lose all the sales but most mfrs lose a lot of it. Let's say 1.3 BB in sales loss would probably mean a 600-800 million/year maybe more loss in profit. Think J&J has put that into their earnings calculation? We'll see if J&J gives an earnings update over the next couple months.
Once a 17 year patnet expires, a company can get a 6 month exension based on providing pediatric studies supporting use in those populations; this is known as pediatric exclusivity; at the end of that 6-month period it is almost impossible to extend the patnet further, thus J&J, though exhausting all avenues to extend, knew quite well the potetnial downside of the Duragesic patent extension;
This action was expected although JNJ hoped the citizen's petitions might hold until the end of the first quarter. As of today only Mylan and Sandoz are shipping in the market (and I believe Sandoz is selling for JNJ under the JNJ NDA) so the market will be somewhat stable for generics until the other competitors get approval. JNJ will still take some money from this product although much reduced.
The loss of Duragesic patent protection has been long anticipated and I would think included in the earnings forecasts made public by J&J. The diversity of this large healthcar ecompany makes patent loss tolerable as other sectors will be able to pick-up the slack (loss of revenue).