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January 24, 2011



The litigation issue you brought up is a bit of a side issue for the post, but thanks for pointing out the unintended consequences of Hatch-Waxman (the large number of ANDA suits) for those who may not have thought about it. Sometimes it appears that Hatch-Waxman benefits patent litigators more than the public, and the associated costs are definitely counter-productive to the intent of the act. I don't think I have a good proposal to address the issue, but more people need to be aware of it.

Regarding the large number of Hatch-Waxman suits, I think a good solution might be to simply lengthen the data exclusivity period. It's currently only 4-5 years (depending on the type of ANDA filed).
Also, here are some interesting numbers to consider:
Number of New Drugs Approved in 2009 = 24 (17 new molecular entities and 7 BLAs approved).
Number of Generic Drugs Approved in 2009: 533 (489 ANDAs and 35 505(b)(2) applications approved).

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