Practical guide to forecasting generic drug launches: Webinar Follow-up

[diana.papshev]

Generic forecasting remains one of the hottest topics on DrugManagementForum. To synthesize and expand this discussion, last week we rolled out our Webinar series in this area.

Highlights of Generic Forecasting Rules:

Since our June 2009 Webinar (see more details here) was the first in the series, we’ve tried to cover a lot of ground in terms of fundamentals, here are the highlights:

Forecasting Rule #1 - Do not assume that a generic product will become available only after all patents and market exclusivities expire
o Resources: FDA’s Orange Book

Forecasting Rule #2 - If a product has unexpired patents, check if any of them have been challenged through ANDAs with paragraph IV certification
o Resources: FDA’s Paragraph IV Certification List

Forecasting Rule #3 - If a patent challenge resulted in litigation, try to find out which patents are being defended
o Resources: Orange Book Blog, PatentDocs, Google searches for news articles and press releases, corporate websites for annual reviews and Securities and Exchange Commission filings, Drugs@FDA

Forecasting Rule #4 - Follow the lawsuit, just remember that unless there is a settlement, nothing is definitive in patent litigation
o Resources: same as above

Webinar Proceedings:

Webinar proceedings are available for download EXCLUSIVELY FOR THE REGISTERED MEMBERS of DrugManagementForum and LOG-IN IS REQUIRED. If you haven't registered yet, please click here - the forum is open exclusively for those in the managed care sector (no pharma) and registration is free.

Webinar presentation AND video/audio recording - To access the proceedings, you must log in and then click here

Participant Questions and Follow-up Discussions:

The participant response was overwhelming. We also received a number of important questions that could not be fully addressed during the June 2009 Webinar. Over the next few weeks we would like to open the discussion on these questions to our entire community:

o Generic ANDAs without bioequivalence and different delivery mechanisms
o Generic exclusivity and ANDA information
o Generic ANDAs in the context of Citizen Petitions
o Estimating generic availability for Protonix