Posted by utopizen on June 12, 2003, at 20:40:40
In reply to Generics/Reverse Engineering » utopizen, posted by Jack Smith on June 12, 2003, at 19:15:14
It's simple- reverse engineering means you produce the drug without prior knowledge of the brand name drug's production methods.
It requires a person to sign a statement claiming they've never seen any information on how to produce the product, then they take the drug and the certain information that the FDA requires the brand name drug's maker to hand over to the generic companies, and make it from scratch. Then they have to prove it's to a certain point similar in potentcy, etc., to the brand name.
Desoxyn hasn't been made generic because even if it wasn't scheduled, its sales are so slow that even Abbott didn't bother to ever market it (they did when it came out in 1943, and even made compounds that included barbituate Nembutal to produce "Desbutal" in the 60's, but it was too abused and the FDA told them to stop making it).
So it was popular in the 60's, but the Controlled Substances Act of 1970 stifled its sales to the point where my past pdoc, who's a Harvard Med grad and child + adult psychopharmacologist since '68, told me with an odd look "I've never heard of that." Many doctors haven't.
Abbott is a big company. It's not worth it to them to market Desoxyn because they'd rather spend whatever that would cost on their more profitable drugs. But to a small, 20-employee upstart, Ovation thinks it's an under-marketed drug and wants to focus in on it to make a profit, along with the Traxene they also bought.
As far as the MAOIs go, I read in California there's about 800 prescribed a year. And that's one of the most populated states in the country! Distribution alone is a problem whenever you're dealing with a rarely prescribed drug, so it's not justifiable to spend tens of millions of dollars to reverse engineer a drug that you would be lucky to not LOSE money simply distributing it.
poster:utopizen
thread:233097
URL: http://www.dr-bob.org/babble/20030609/msgs/233551.html