Went to FDA web site and searched through March 2013 and found no generic Dacogen approved. If so, a generic manufacture would have to submit and get approval. Then marketing, insurance etc. If Dacogen goes off patent US in May, I would think generic approval including manufacturing needs to be done. How much time does this take? How long to scale up? Get insurance and doctors on board?
Just read the transcript. The paragraph 4 question and response is interesting. A generic drug manufacture needs to notify Astex that patent for Dacogen has expired. This notification allows Astex the right to defend its patent in court before they can manufacture a generic. Per Manuso's comment, a generic drug manufacture has not done this yet.
Another thing I picked up in the transcript it sounds like Manuso is expecting a milestone payment to off set loss or minimize loss for drug development. He is not directly saying this but he infers this. I some what remember for the Astex purchase, Supergen advertised a potential 2 billion in combined milestone payments for the combined company if the shareholders approved the sale. In the transcript a 800 million dollar potential is mentioned. Which is correct?
hey mero look at my post on generic i messed up on the name though it should be generic drug info ( phase 1 study BIOAVAILABILITY )
and from what i understand once the drug goes into expiration it is put on a list called the orange book which actually is just a list of names of drugs available for generic. at that moment the generic company may file for the generic and start to get all the appropriate studys together to compare the brand name to the generic. i still dont understand what bioavailability is but thought i would let you know what i found