Timing is Everything! . . . In Life and In Hatch-Waxman; Fun With 180-Day Exclusivity Forfeiture

By Kurt R. Karst –      

Despite amendments to the statute, court decisions, and FDA interpretations, there has been one constant throughout the nearly 29-year history of the Hatch-Waxman Amendments: dates matter.  If a company – or FDA – misses a deadline by just one day, then opportunities provided by the statute can be lost.  (Well, except in one case, but that took a decade to resolve.)  Those opportunities may be on the brand side of the equation (e.g., timely filing a patent infringement lawsuit or timely submitting information to FDA for Orange Book listing a patent), or on the generic side of the equation (e.g., qualifying for and forfeiting 180-day exclusivity).  A recent split decision by FDA on 180-day generic drug exclusivity for generic LUVOX CR (fluvoxamine maleate) Extended-Release Capsules, 100 mg and 150 mg, nicely makes the point on how important dates are under the Hatch-Waxman Amendments.

Anchen Pharmaceuticals, Inc. (“Anchen”) submitted ANDA No. 091476 to FDA on April 13, 2009 seeking approval to market a generic version of only the 150 mg strength of LUVOX CR.  Just a week later, on April 20, 2009, Anchen amended its ANDA to seek approval of the 100 mg strength as well.  Both the original ANDA and the new strength amendment contained Paragraph IV certifications to patents listed in the Orange Book for LUVOX CR.  In both cases, Anchen’s Paragraph IV certifications qualified the company as a fist applicant eligible for 180-day exclusivity. 

Under the statute – at 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 [FDA] 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).  The 2012 FDA Safety and Innovation Act made further changes with respect to the application of FDC Act § 505(j)(5)(D)(i)(IV) to certain ANDAs (see our previous post here).  Those changes are not relevant here.  (For a list of some of the circumstances excusing the failure to obtain timely tentative approval see here.)

The 30-month tentative approval dates for Anchen’s ANDA No. 091476 – October 13, 2011 for the 150 mg strength and October 20, 2011 for the 100 mg strength – came and went without any action on the ANDA.  Fast-forward to March 13, 2013 when FDA finally approved both strengths under ANDA No. 091476. . . .

FDA notes in the approval letter that Anchen failed to obtain timely tentative approval for both strengths under the ANDA, and, therefore, that eligibility for 180-day exclusivity could be forfeited.  But wait, wrote FDA, there was a change in or a review of the requirements for approval of the application imposed after the date on which the ANDA was considered received (i.e., filed).  “Specifically, there were revisions in the labeling of the RLD that necessitated changes in Anchen’s labeling that were not resolved until October 18, 2011 . . . .” (Emphasis added). 

The October 18th date, however, falls in between the October 13th 30-month date for the 150 mg strength and the October 20th 30-month date for the 100 mg strength.  The October 18th date resulted in FDA issuing a split decision.  For the 150 mg strength, FDA determined that 180-day exclusivity eligibility was not forfeited, because “there were revisions in the labeling of the RLD that necessitated changes in Anchen’s labeling that were not resolved until October 18, 2011, which is after the 30-month forfeiture date for the 150 mg strength.”  For the 100 mg strength, however, 180-day exclusivity eligibility was forfeited, because “the changes in the requirements for approval related to the RLD labeling revisions were not a cause of Anchen’s failure to obtain tentative approval of the 100 mg strength within the 30-month period . . . because those issues were resolved prior to October 20, 2012.”

Timing truly is everything in the Hatch-Waxman world.  The Anchen/generic LUVOX CR case illustrates this fact.  But it also serves as a gentle reminder for companies to communicate to FDA important dates to try and avoid forfeitures of 180-day exclusivity eligibility.