Webinar: Avoiding Drug Substance Patents and Exclusivities – Prodrugs, Deuterated Drugs, and 505(b)(2) Applications

April 4, 2016

For generic drug companies, the biggest and most expensive challenge to a US product launch is the patent that covers the Active Pharmaceutical Ingredient (“API”). Notoriously, only one such patent has ever been invalidated for obviousness.

On Thursday, April 14, 2016, from 9:00 AM – 10:00 AM EST, Kurt R. Karst (Hyman, Phelps & McNamara, P.C.) and Jeffrey A. Hovden (Robins Kaplan LLP) will present a primer on strategies for generic drug manufacturers to get around API patents, using the 505(b)(2) application. This route can enable a generic company to use a prodrug or deuterated drug to avoid the API patent—and brand marketing exclusivities—while still benefiting from brand safety and efficacy data.

The presenters will use particular examples to illustrate the pros and cons of this basic strategy, discussing current law and FDA regulations, helping you to plan for and maximize such opportunities. You can register for the webinar here.

Categories: Hatch-Waxman