Six First to File Paragraph IV ANDAs Reported By OGD – But Where Are the Approvals?

The Office of Generic Drugs (OGD) listed 6 first-to-file (FTF) ANDAs with Paragraph IV (PIV) challenges yesterday.  It is interesting to note that all were originally submitted in 2014-the oldest submission date was in April 2014 and the newest in July of this year.   We know that OGD gives priority acceptance review to FTF ANDAs and the 2014 dates may signify that the priority acceptance review of PIV submissions is in full swing.

Alcaftadine Ophthalmic Solution 0.25% Lastacaft 7/30/2014
Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray 137 mcg/50 mcg per spray Dymista 6/13/2014
Exenatide Injection 250 mg/mL, 1.2 mL and 2.4 mL prefilled syringe Byetta 6/11/2014
Paroxetine Capsules 7.5 mg Brisdelle 4/7/2014
Ribavirin For Inhalation Solution 6 gm/vial Virazole 5/22/2014
Topiramate Extended-release Capsules 25 mg, 50 mg, and 100 mg Trokendi XR 5/12/2014


Of interest is that at least two of the NDA products subject of PIV ANDA challenges were first approved in 2013, one was first approved in 2012 while two oldies (one approved in 2005 and another first approved in 1985) were first targets of generic submissions.

So, while firms are looking to gain approval for both recently approved products and older more established brands with either no or a few generic entries (with new patents listed), many firms are crying for any approval.  But it looks like October is going to be a very dry month unless something dramatic happens in the next 7 days.  There have only been three ANDA approvals so far through October 21.  This is somewhat troubling, especially after the last three months have seen the fewest number of submissions in recent history.

What could be causing the slowdown?  Well, maybe there are just no applications  that have been able to reach the approval stage?  However, this would seem inconsistent with OGD’s historical approval patterns.  Are all resources jumping on applications submitted for cohort year three in order to assure the metrics for year three are met?  This is also an unlikely scenario since we understand that not that many ANDAs have been submitted so far in October, the first month of the first metric cohort.  Well, then what could it be?  Your guess is as good as mine (and maybe even better).

Perhaps there are tons of Complete Response Letters (CRLS) that were issued in October?  We will see when the October OGD activities report is released.  No, this lack of approval activity is something I just cannot figure out.  Applications have clearly been cycling through CRLs in the first two years of GDUFA and with the easily correctable deficiency letter, one would think that some of those applications (or at least the “backlog” applications) must be ready to pop out on the approval side of the ledger.   Perhaps we will hear some words of wisdom at the upcoming GPhA Fall Technical Workshop.  I know that generic industry leaders will be listening closely and their patience appears to be wearing thin.  I am certain that at least one industry group is smiling at the low approval numbers and that would be PhRMA.