180-Day Exclusivity Guidance – Oh, How Sweet It Is

Like looking for something in the junk drawer in your house, you know it’s in there, but you really must rummage around to find it.  The FDA issued its Guidance for Industry: 180-Day Exclusivity:  Questions and Answers earlier this week and it is the junk drawer of 180-day exclusivity.  It contains a compilation of questions and answers that bring together FDA’s decisions on 180-day exclusivity that may have come from court cases, petition responses, or letters of decision on all types of 180-day exclusivity issues, all in one place.

As noted in the Guidance document. “FDA believes that a guidance for industry that provides answers to commonly asked questions about 180-day exclusivity would enhance transparency and facilitate the development, approval, and timely marketing of generic drug products.”  This is something that the industry has been waiting for and now we can clean out our junk drawer! So, thank you, FDA.

The Guidance covers mostly post-Medicare Modernization Act (MMA) issues, but also talks about the pesky potential hangover pre-MMA 180-day provisions that may sometimes unexpectedly raise their ugly head.

While most of the contents are not new, having everything in one place certainly provides the reader a good overview of issues related to 180-day exclusivity.  The Q&A format provides a concise answer to many common questions like “Does an ANDA applicant have to be the first to submit a paragraph IV certification to all of the RLD’s listed patents to be a first applicant?” or “Can an ANDA applicant be a first applicant if the applicant includes a paragraph III certification to a patent that expires after the patent to which a paragraph IV certification was submitted?” And how about “Could the timing of sending notice of paragraph IV certification affect first 258 applicant status?”  Oh, and here is one that I bet may be new to most readers: “Can pediatric exclusivity affect the timing of approval of subsequent applicants’ ANDAs after the 180-day exclusivity period is triggered?”  This is question 20 – make certain you read it closely because it could mean you may not really be able to go to market when you thought!

There are also several questions answered regarding the forfeiture provisions of 180-day exclusivity, which make more clear a very confusing topic. In all, there are 45 important questions with answers in this draft Guidance document (here).  This is a must read (and must understand) document for all involved in the generic world.