Avoiding Drug Substance Patents and Exclusivities

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.

We present a primer on strategies for generic companies 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.

We’ll 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.