What is the 505(b)(2) pathway?

We’re all aware of New Drug Applications (NDA) for brand new medicines, and Abbreviated New Drug Applications (ANDA), for generics, but what about the third hybrid option called 505(b)(2)?

For those who develop a drug that shows a direct connection to the API from an existing approved one, manufacturers have the opportunity to acquire FDA approval via the 505(b)(2) pathway without the need to complete a full lengthy NDA.

Considering these newly developed medicines are not strictly generic copies of existing drugs (and therefore don’t fit into the ANDA category) they gain the benefit of longer exclusivity and faster speed to market than their cousins, despite being fundamentally the same.

Transdermal patches fit perfectly into this submission niche, transforming proven and tested pharmaceuticals into skin permeation delivery systems, and market leaders Greene Street Pharmaceuticals leverage this method to offer a full spectrum of Transdermal Innovative Products.

By using supporting evidence from other researchers along with their own studies in their FDA submission, Greene Street 505(b)(2) approved products are eligible for 3-5 years of market exclusivity, making them an exciting area for many in the industry to watch and explore.

Get in touch with us today to learn more!