Applied Market Data assists market participants in the generic drug space by providing data analysis and decision support tools that provide stakeholders with insight into the structure and direction of generic drug markets. This comprehensive view of the competitive landscape allows decision makers to visualize trends and opportunities.

 

As competition among generics suppliers for new products accelerates and would-be ANDA filers become increasingly aggressive in attempting to identify future opportunities, their ANDA filing strategies have come to reflect this. It’s is no longer uncommon for the owners of brand drug NDAs to find a list of tentative ANDA approvals in the FDA queue as their patent and/or exclusivity protection comes to an end. P (iv) filings are now routine for most brand drugs, requiring NDA holders to decide on a legal strategy to protect the brand often many years before existing patents for their products are due to expire.

 

The end result is a generic drug segment that is rapidly evolving and highly unpredictable – an environment that lacks a true data compass to assist decision makers in mapping strategies for success in this segment. Attempting to determine the optimal time to file an ANDA application is a process that can be worth hundreds of millions in profits for first-to-filers. But it is a process that is fraught with risk and potential consequences.