ANDA Preparation (with an Eye toward Approval and Litigation) and the FDA Review

As a manufacturer of generic drug products, undoubtedly one of your goals is to prepare an Abbreviated New Drug Application (ANDA) that will pass regulatory scrutiny efficiently. Your ANDA submission is a culmination of time, money, and effort by many in your organization: from those responsible for identifying target products to those responsible for developing those products and, finally, to those responsible for filing the application. This effort can take several years, and even the smallest missteps can result in months of delay and possibly millions in lost revenue and sunk costs. Keeping your goal in mind, every communication that you have with the Food and Drug Administration (FDA) should be made with an eye toward making the FDA’s job of reviewing your ANDA easier so that you can get your approval faster.

But as you probably already know, your ANDA can be a technical act of patent infringement that triggers a patent infringement lawsuit from your adversary under the Hatch-Waxman Act. Let’s face it: the ANDAs with the most potential reward are the ones most likely to be sued on. Your ANDA filing, therefore, should be made with an eye not only toward regulatory compliance and approval but also toward the litigation that will likely follow. If your team has devoted the effort to developing a Paragraph IV strategy, make sure that the entire ANDA submission accurately portrays the proposed ANDA product in light of the potential patent obstacles.

Originally published in Pre-ANDA Litigation: Strategies and Tactics for Developing a Drug Product and Patent Portfolio on August 12, 2014.

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Published In: Administrative Agency Updates, General Business Updates, Health Updates, Science, Computers & Technology Updates

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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