FDA Resolves Eligible/Ineligible First Applicant 180-Day Exclusivity Forfeiture Issue in the Context of Generic STARLIX (Nateglinide) Tablets

September 10, 2009

By Kurt R. Karst –      

Since the enactment of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (“MMA”), Hatch-Waxman scholars have wondered how FDA might answer the following question: “What is the effect of a forfeiture of 180-day exclusivity eligibility due to the failure of a first applicant to obtain tentative ANDA approval pursuant to FDC Act § 505(j)(5)(D)(i)(IV) when at least one other first applicant remains eligible for 180-day exclusivity?”  FDA’s September 9, 2009 approval of ANDAs for generic versions of STARLIX (nateglinide) Tablets provides the answer to that question. 

FDC Act § 505(j)(5)(D)(i)(IV), as added by the MMA, states the 180-day exclusivity eligibility is forfeited if “[t]he 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” (emphasis added).  The term “first applicant” is defined at FDC Act § 505(j)(5)(B)(iv)(II)(bb) to mean “an applicant that, on the first day on which a substantially complete application containing a [Paragraph IV Certification] is submitted for approval of a drug, submits a substantially complete application that contains and lawfully maintains a [Paragraph IV Certification] for the drug.”  These and other provisions of FDC Act § 505(j), as amended by the MMA, concerning the scope and effect of 180-day exclusivity effectively create three categories of ANDA applicants relevant to a forfeiture under FDC Act § 505(j)(5)(D)(i)(IV):

(1)  “Eligible first applicants” (i.e., those first applicants who have not forfeited 180-day exclusivity eligibility under FDC Act § 505(j)(5)(D)(i));

(2)  “Ineligible first applicants” (i.e., those first applicants who have forfeited 180-day exclusivity eligibility under FDC Act § 505(j)(5)(D)(i)(IV), but nevertheless remain first applicants because their ANDAs continue to “lawfully maintain” a Paragraph IV Certification); and

(3)  “Subsequent applicants” (i.e., those applicants whose ANDAs contain a Paragraph IV Certification but who are not first applicants, and therefore are subject to an eligible first applicant’s 180-day exclusivity).

In the case of generic STARLIX, we understand that there were multiple first applicants, but that FDA determined that some (but not all) first applicants forfeited 180-day exclusivity eligibility under FDC Act § 505(j)(5)(D)(i)(IV).  This scenario necessarily led FDA to consider several questions, including:

(1) Can an ineligible first applicant obtain approval for its ANDA before commencement and/or expiration of a 180-day exclusivity period triggered by commercial marketing by an eligible first applicant?; and  

(2) If an ineligible first applicant obtains approval and begins marketing of the drug, does that marketing start the 180-day exclusivity period for all eligible first applicants?

FDA’s decision to approve ANDAs for first applicants who forfeited 180-day exclusivity eligibility under FDC Act § 505(j)(5)(D)(i)(IV) by failing to obtain timely tentative ANDA approval affirmatively answers the first question.  And as a result of FDA recognizing that an ineligible first applicant that “lawfully maintains” a Paragraph IV Certification to an Orange Book-listed patent is nevertheless a first applicant, and by operation of FDC Act § 505(j)(5)(B)(iv)(I), which states, in relevant part, that “the first commercial marketing of the drug . . . by any first applicant” (emphasis added) triggers 180-day exclusivity, FDA also answered the second question in the affirmative.

Although FDA has in the past published letters explaining the Agency’s post-MMA 180-day exclusivity decisions, FDA has not yet done so in this case.  FDA could, as the Agency has done in other cases concerning 180-day exclusivity forfeiture under FDC Act § 505(j)(5)(D)(i)(IV), let its approval decisions stand as its explanation and policy. 


  • On September 11, 2009, FDA issued a Letter Decision concerning its determination of 180-day exclusivity for Nateglinide Tablets.


Categories: Hatch-Waxman