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Re: DewDiligence post# 48879

Saturday, 06/23/2007 5:00:05 PM

Saturday, June 23, 2007 5:00:05 PM

Post# of 257257
For most biologics, the manufacturer would have requested and got a patent term extension under 35 USC 156.
The practical limit seems to be 14 yrs from date of approval. This would be an easy way of looking at upcoming expiry I guess.

See http://www.fda.gov/ohrms/dockets/dockets/05e0254/05e-0254-app0001-01-vol.pdf

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