Paragraph IV Patent Challenges – As of July 1, 2008JULY 2008

David Harding, API Intelligence, Thomson ReutersSource: FDA, NEWPORT HORIZON PREMIUMTM © THOMSON REUTERS

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Paragraph IV Patent Challenges - 2008• There are 29 molecules with New Chemical Entity exclusivity

expiring in 2009, so therefore are exposed to Paragraph IV Patent Challenge in 2008

• So far in 2008, 11 molecules (or combinations) have seen their first patent challenges

• Some major products that will likely see a Patent Challenge include:

– Duloxetine HCl

– Pregabalin

– Levocetirizine

Source: FDA, Newport Horizon Premium™, data as of 7/1/2008 © THOMSON REUTERS

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