McAndrews

About

  • The Orange Book blog team are a group of attorneys with McAndrews, Held and Malloy, which is a full-service IP firm representing both brands and generics in various aspects of IP law. This blog does not provide legal advice. If you are seeking legal advice, please contact the author directly.

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  • Orange Book Blog is published for informational purposes only; it contains no legal advice whatsoever. Publication of Orange Book Blog does not create an attorney-client relationship. Orange Book Blog is not edited by McAndrews, Held & Malloy, Ltd. ("MHM") or its clients. The views expressed are solely those of the authors, and may not reflect the views of MHM or its clients. No part of Orange Book Blog--whether information, commentary, or other--may be attributed to MHM or its clients. MHM represents many companies in the pharmaceutical and biotechnology industries, and therefore Orange Book Blog may occasionally report on news that relates to MHM clients. Orange Book Blog will always strive to be unbiased. All information on Orange Book Blog should be double-checked for its accuracy and current applicability.

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October 01, 2008

Non-Patent Exclusivity and 180-Day Exclusivity Forfeiture Slides Posted

Last week, I gave a talk about non-patent exclusivity at ACI's FDA Boot Camp conference in Boston.  The talk covered new chemical entity (5-year) exclusivity; new clinical trial (3-year) exclusivity; orphan drug exclusivity; pediatric exclusivity; and generic drug (180-day) exclusivity.  You can download a copy of my slides here.

In June, I gave a talk about forfeiture of 180-day exclusivity at IIR's Generic Drugs Summit conference in Washington.  The talk included a discussion of the "failure to market" forfeiture provisions, particularly the FDA's Acarbose and Granisetron decisions.  You can download a copy of those slides here.

Posted by in 180-Day Exclusivity, Conferences, Pediatric Exclusivity |

Comments

M.R.Syam Sundar

Excellant and simple to understand

Posted by: M.R.Syam Sundar | April 30, 2011 at 01:24 PM

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