180-Day Exclusivity – From Abacavir Sulfate to Zolpidem Tartrate

August 10, 2010

By Kurt R. Karst –   

For years now, folks (of the Hatch-Waxman type) have clamored for a full list of 180-day exclusivity decisions.  FDA has not put together such a list, so we decided to try and put together our own list – the 180-Day Exclusivity Tracker.  And now we know why nobody has previously put together such a list.  Like all things Hatch-Waxman, it is quite complicated and takes a lot of time to figure out.  Imagine, if you will, coming across a cache of 5,000-piece puzzles in your grandmother’s attic.  You’re a puzzle fanatic, so you decide to take on the task of putting them together.  But you quickly realize that all of the puzzles are pictures of similar forestscapes and that some of the pieces are missing.  That’s the type of situation we faced when we decided to build the 180-Day Exclusivity Tracker.  We needed to consult many sources, including historical Orange Book listings, Drugs@FDA (where many ANDA approval letters are not linked to), FDA’s first generic approvals database, other government databases (e.g., EDGAR), court documents, and press reports – sometimes to no avail.  But in the end, it is all worth the effort.  

The 180-Day Exclusivity Tracker appears on the right-hand side of the FDA Law Blog along with our other popular trackers – the FDC Act § 505(q) Citizen Petition Tracker, REMS Tracker, and FDA Legislation Tracker.  (It is a large file and might take a minute to download.)  The 180-Day Exclusivity Tracker is in Excel Spreadsheet format and is based on FDA’s Paragraph IV Certification List, although we added some drugs to the list, including drugs for which old exclusivity determinations from the 1980s (pre-Mova) were made, and others that were likely mistakenly omitted from FDA’s list.  Once you open the tracker, you should see lettered tabs at the bottom of the document – one for each letter of the alphabet.  (If you do not see the lettered tabs, then minimize the document.)  There are 8 columns of information for each drug listed: “Drug,” “Dosage Form,” “Strength,” “RLD,” “Date of Submission,” “ANDA Approval Date,” “Approval Letter,” and “Exclusivity Decision.”  In some cases, the “Date of Submission” for a particular drug is blank (just as in FDA’s Paragraph IV Certification List), because it is unclear to us what the date is.  We have filled in some of the blanks on FDA’s list with a pre- or post-Medicare Modernization Act (“MMA”) notation, which dictates whether or not the MMA’s forfeiture provisions come into play.  Under the “Approval Letter” column, we include a particular ANDA number and a link to the approval letter (when available).  Under the “Exclusivity Decision” column we note for each drug (when possible) whether exclusivity has been granted, whether it is pre- or post-MMA exclusivity, whether exclusivity has been forfeited, shared, waived, or relinquished, as well as other information (e.g., suitability petitions, tentative approvals).  We also provide a link to relevant FDA decisions.  Additional bells and whistles might be added as time goes on.

The information included in the 180-Day Exclusivity Tracker is based on the best publicly available information we could find.  In some instances we make an assumption.  For example, when the first generic for a particular drug product is approved after the last expiring Orange Book-listed patent, we assume that FDA did not grant any first applicant 180-day exclusivity – 180-day exclusivity dies with patent expiration.  In other cases, there is not enough information for us to come to any conclusion on what happened to 180-day exclusivity and there is a blank in the tracker.  In many other cases, there are blanks because FDA has not yet made an approval decision (e.g., for ANDAs for which the “Date of Submission” is in 2009 or 2010).  We will try to update the tracker on a regular basis – at least once a month – as new approval and exclusivity decisions are made.  The “last updated” date will appear in the “A” tab heading.

We kindly request from our loyal FDA Law Blog readers who have made us such a success (we recently ranked about 2,000 out of 1.19 million blogs on Technorati) that if you are able fill in any of the missing information in the 180-Day Exclusivity Tracker (or if you think we should clarify information we have filled in) that you contact us by sending an e-mail to kkarst@hpm.com.  Thank you, and enjoy the 180-Day Exclusivity Tracker!

Categories: Hatch-Waxman