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Biotech / Medical : Elan Corporation, plc (ELN) -- Ignore unavailable to you. Want to Upgrade?

To: fred hayes who wrote (3463)	10/31/2002 12:17:35 PM
From: biostruggle	Read Replies (2) \| Respond to of 10345

The patent on skelaxin has expired. But Elan filed an adendum to orange book and was excepted by FDA. Orange book is requirements generic manufactures have to do for bio-equivalance. The generic manufactures have to replicate Elans pharmokinetic data. Elan did the pharamkinetic studies using a new formulation of skelaxin. The patent you pick up is on the formulation. So a generic manufacture has to replicate Elans data using a different formulation. Once done their free to compete. Note this is the kind of patent extention that Bush is proposing to remove through legislation. So Elan can lose skelaxin either through succesful pharmokinetic trials by generics or it could be legislated away next year.