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Pfizer v. Reddy: Drug Patents Under Fire

Executive Summary

Generic firms are attacking drug patents--even before they expire--with increasingly clever legal strategies. And it looks like the FDA may be helping them do it.

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Authorized Generics: Band-Aid or Strategy?

In the past two years, some Big Pharma companies have revitalized their long-dormant generics activities and launched generic copies of their own drugs. They're doing this to capture business they would otherwise lose completely and to tie up generics competitors in court. While similar strategies failed in the past, a number of changes may make it more feasible. Innovators are behaving more rationally about pricing. And they are going after the most lucrative part of the generics business.

FDA Faces Mounting Pressure on Shortcut Approval Pathway

The FDA has recently come under fire by big pharma and big biotech. The issue: FDA's interpretation of a section of the Federal Food, Drug, and Cosmetic Act-505(b)(2)-which allows companies to rely on data other than their own to attain drug approval.

FDA Faces Mounting Pressure on Shortcut Approval Pathway

The FDA has recently come under fire by big pharma and big biotech. The issue: FDA's interpretation of a section of the Federal Food, Drug, and Cosmetic Act-505(b)(2)-which allows companies to rely on data other than their own to attain drug approval.

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