By Kurt R. Karst –
That’s the picture conjured up when we plugged some dates into the new model for calculating forfeiture of 180-day generic drug marketing exclusivity for certain ANDAs – what we are calling “window ANDAs” – covered by Section 1133 of the recently enacted FDA Safety and Innovation Act (“FDASIA”).
FDASIA § 1133 concerns FDC Act § 505(j)(5)(D)(i)(IV), which is one of the six 180-day generic drug exclusivity forfeiture provisions added to the FDC Act by Title XI of the 2003 Medicare Modernization Act. Under FDC Act § 505(j)(5)(D)(i)(IV), 180-day exclusivity eligibility is forfeited if:
The first applicant fails to obtain tentative approval of the application within 30 months after the date on which the application is filed, unless the failure is caused by a change in or a review of the requirements for approval of the application imposed after the date on which the application is filed.
The 2007 FDA Amendments Act clarified FDC Act § 505(j)(5)(D)(i)(IV), such that if “approval of the [ANDA] was delayed because of a [citizen] petition, the 30-month period under such subsection is deemed to be extended by a period of time equal to the period beginning on the date on which the Secretary received the petition and ending on the date of final Agency action on the petition (inclusive of such beginning and ending dates) . . . .” FDC Act § 505(q)(1)(G).
FDASIA § 1133 covers two cohorts of ANDAs – one under subsection (a) and another under subsection (b). For both sets of ANDAs covered by FDASIA, the intent of the law is two-fold. First, FDASIA accounts for FDA’s growing median ANDA approval time – about 32-33 months today – which has led to many companies forfeiting 180-day exclusivity eligibility. Second, FDASIA § 1133 addresses FDA’s strict interpretation of FDC Act § 505(j)(5)(D)(i)(IV), such that when an ANDA sponsor who amends a long-pending ANDA to include a Paragraph IV certification to an Orange Book-listed patent and qualifies as a “first applicant,” that sponsor may simultaneously forfeit 180-day exclusivity eligibility for failure to obtain timely tentative approval. This has happened because FDA counts 30 months from the ANDA submission date rather than from the first Paragraph IV certification date (see our previous post here).
FDASIA § 1133(a) covers ANDAs submitted to FDA between January 9, 2010 (actually, January 11, 2010, because January 9th is a Saturday) and July 9, 2012 initially containing a Paragraph IV certification to a patent listed in the Orange Book for the Reference Listed Drug (“RLD”), or that is amended between January 9, 2010 and July 9, 2012 to first contain a Paragraph IV certification to a patent listed in the Orange Book for the RLD. It provides that the time to obtain timely tentative approval (or final approval if tentative approval is not warranted) is 40 months during the period of July 9, 2012 and September 30, 2015, and not 30 months. During the period beginning on October 1, 2015 and ending on September 30, 2016, the period is 36 months and not 30 months.
FDASIA § 1133(b) covers ANDAs first amended after July 9, 2012 to contain a Paragraph IV certification. Specifically, this subsection provides that for an ANDA submitted to FDA prior to July 9, 2012 that is first amended on July 10, 2012 and up to September 30, 2017 to contain a Paragraph IV certification to a patent listed in the Orange Book for the RLD, the date of the amendment starts to 30-month tentative approval forfeiture period instead of the original ANDA submission date.
While all seems well with the FDASIA § 1133(b) window ANDAs, there appears to be a problem with the FDASIA § 1133(a) window ANDAs. In particular, the 36-month extension date is inapplicable (absent an applicable 505(q) citizen petition). By the time this provision takes effect on October 1, 2015, the youngest ANDA to which it could apply – i.e., an ANDA submitted to FDA on July 9, 2012 or amended on that date to first contain a Paragraph IV certification – will be nearly 39 months old. If such an ANDA is tentatively approved on September 30, 2015 when the tentative approval period is still 40 months, there would not be a forfeiture. If, however, that same ANDA is tentatively approved one day later, on October 1, 2015, there would be an automatic forfeiture.
In addition, we note that the youngest window ANDA to which FDASIA § 1133(a) can fully apply (i.e., an ANDA that could potentially enjoy the full 40-month period absent an applicable 505(q) citizen petition) is an ANDA submitted (or first amended with a Paragraph IV certification) on May 30, 2012 and tentatively approved on September 30, 2015. Such an ANDA would be tentatively approved within the 40-month period (depending on what it means to be tentatively approved “within” the specified timeframe – see our previous post here.) An ANDA submitted (or first amended with a Paragraph IV certification) after May 30, 2012 would not enjoy the full 40-month period.