Ok, here's my take on the ELI-216 vs generic drug launch discussion. Elite already has time released technology they are/were using for their Lodrane D products in the once daily delivery vehicle.
If they are going to make generic timed release products, they don't need any fancy 2 bead, abuse resistant, patented technology, they just put the active ingredients in their 24 hour delivery vehicle and make the capsules/tablets and do the bio-equivalence studies, submit them to the FDA for approval, and start marketing them as soon as they have approval.
The 2 bead technology would only be necessary for abuse resistance products, imo, therefore they would only need 1 bead technology to market their generic products, or they could use the same process they are using now for their Lodrane D products.
That's all I'm asking, is using the patented beads going to give better bio-equivalence results than the Lodrane D technology, which many generic companies probably are using similar delivery vehicles as Elite's Lodrane products, vs the patented beads? A bio-equivalence study on a 24 hour product must closely mirror initial release and therapeutic blood levels timeframes, as well as steady state blood levels that are very similar to the brand name being copied, otherwise it won't achieve the AB rating necessary to be substituted on most Federal and State formularies.
So interesting to see how the company plans on using the 216 beads in making new generics...
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