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Gold/Mining/Energy : Nuvo Research Inc
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To: axial who wrote (13711)10/6/2004 11:03:09 PM
From: russet  Read Replies (1) of 14101
 
3 - The FDA will, however, normally give a 3-year period of marketing exclusivity to a newly-approved drug. What does this mean? You can't market without FDA approval. If the FDA doesn't give approval to another company, then they can't sell Pennsaid. So even though the patent has expired, the FDA will still grant you a marketing monopoly to replace your patent monopoly. In the States, you still have the market to yourself for 3 years.


The FDA might grant you this,...and they might not. The don't have too. Unless DMX gets a strong US based marketing partner to lobby for this, they'll probably get nothing.

This will not stop any other company from submitting their DMSO based clone drug for FDA approval. It doesn't have to be a generic. It could involve other NSAIDs or pain killers and other components and nothing in patent law could stop it from being approved,...maybe even before Pennsaid.
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