There is also a New Clinical Investigation Exclusivity – 3 years. A clinical investigation that provides a "new" basis for approval of an application can qualify for this exclusivity.
sokol, question for you. You said.. "Patents too are listed in the FDA's Orange Book in the FDA's ministerial capacity. As long as any patent for AVXL 2-73 is listed in the FDA's Orange Book, it will not authorize a generic version of AVXL 2-73 for any use."
I noted the "for any use" there at the end. Is the FDA not sensitive to the type of patent (composition vs method of use)? What about the case where a drug's original "composition of matter" patent has expired and the only non-expired patent is a method of use patent for a particular indication? It seems to me if what you said is true then pharma's could almost indefinitely hold off a generic for ALL possible indications by submitting a new method of use patent for their drug to the Orange book every so often. That doesn't seem like the way it works. What am I missing?
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