Generics

In a (not unexpected) petition denial, the FDA confirmed the statutory requirement that the 5 year New Chemical Entity (NCE) starts on the date of the letter approving the NDA. While this has long been the standard, this case does have a wrinkle that at least two firms, Eisai and UBC, argued in almost identical petition requests. The products in question were substances with abuse potential and also clearly qualified as first time approvals of the drug entity that guaranteed them 5 year NCE. However, because they were controlled substances, there was a need for the Drug Enforcement Administration to formally schedule the product prior to the firms actually being able to market them, even though the firms had final FDA approval in hand.

In a letter issued April 24, 2014 to ANDA applicants for Celecoxib, the FDA explained its rather complicated view of how to treat reissue patents as they relate to 180-day exclusivity and 30-month stays. And, in this case, the FDA did not provide a decision on 180-day exclusivity for any Celecoxib applicant because exclusivity determinations are not made until an ANDA that may be subject to either 180-day exclusivity or may be blocked by such are approved. In the former case, FDA would indicate the eligibility for the 180-day exclusivity, and, in the latter, would issue a Tentative Approval letter indicating that the application (while meeting all other approval requirements) cannot receive final approval due to another applicant being eligible for 180-day exclusivity. As things stand today, there are three firms that have tentative approval letters (Mylan, Teva, and Watson).

The first ANDA for Vivus’s diet drug Qsymia (phenteramine hydrochloride and topiramate) appeared in today’s Paragraph IV new postings. The Paragraph IV database is where first-to-file ANDAs containing Paragraph IV challenges to the reference listed drug are posted. The receipt date reported on the FDA site is July 18, 2013, which is just 6 days more than a year since Qsymia was approved (July 12, 2013).

Qsymia is an extended-release product; thus, the turnaround for generic development, generation of required stability data, conduct of successful bioequivalence studies and putting the ANDA together was almost as much time as FDA took to decide the ANDA was acceptable for receipt (almost 10 months).

Had trouble getting hold of someone at the Office of Generic Drugs (OGD) lately? Just wait until next week! The long awaited OGD move to White Oak starts next week and will stretch over at least three weeks.

Six months into Fiscal Year 2014 and some staggering submission numbers should send a chill up the old OGD spine. So far, this FY OGD has received 597 new original ANDAs based on numbers released on April 11, 2014. That number reflects activity through the end of March 2014. On the other hand, OGD has approved 392 ANDAs in the first 6 months of this FY. So let’s look at the numbers a bit more closely.

There are a number of dilemmas looming over generic drug firms in 2014 – some with no easy answers, but hopefully firms are considering their choices sooner rather than later. Two of these issues relate to the all-important question “Exactly when should the ANDA be submitted?”. Any generic drug firm knows that that answer is never easy and is dependent on many factors, such as biostudy success, completion of stability testing, facilities being ready for inspection and first-to-file opportunities, just to name a few. And of course, such practical scientific or regulatory deadlines are further complicated by the directed business goal of “the sooner the better”.

In trying to read the tea leaves at the Office of Generic Drugs (OGD) and discussing issues that really worry both OGD and industry, I have come across two issues that you need to stay on top of, one during the approval process and the other just after ANDA approval, to avoid a potential delay in approval that you did not see coming or a potential change in the way OGD does business relative to ANDAs subject to the valuable 180-day exclusivity provisions of the Act.