FDA Rules Against Forfeiture for Generic ALDARA Cream

March 9, 2010

By Kurt R. Karst –      

FDA’s recent approval of Nycomed U.S., Inc.’s ANDA No. 78-548 for a generic version of ALDARA (imiquimod) Cream, 5%, appears to be the first instance in which FDA has determined that a first ANDA applicant is eligible for 180-day exclusivity on the basis that there was not a  forfeiture of such exclusivity because of a change in or review of ANDA approval requirements and no other forfeiture provision applied.

FDC Act § 505(j)(5)(D)(i)(IV) – “Failure to obtain tentative approval” – is one of the six 180-day exclusivity provisions added to the FDC Act by Title XI of the 2003 Medicare Modernization Act (“MMA”), and provides that 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 clarrified 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)).) 

As we previously reported, there has been one case in which tentative approval was not obtained within 30 months of ANDA submission and where FDA determined that exclusivity was not forfeited because of a change in or review of ANDA approval requirements – ANDA No. 77-532 (Acarbose Tablets, 25 mg, 50 mg, and 100 mg).  In that case, FDA ruled “that a change in bioequivalence requirements resulted in a delay in obtaining a tentative approval” and did not result in a forfeiture under FDC Act § 505(j)(5)(D)(i)(IV); however, FDA also determined that there was a forfeiture under its interpretation of the failure to market forfeiture provisions at FDC Act § 505(j)(5)(D)(i)(I) (which the D.C. Circuit recently struck down).  In the Acarbose case, although a citizen petition was submitted to FDA, because the petition was submitted to FDA after the date that was 30 months after ANDA submission, FDC Act § 505(q)(1)(G) was not implicated.

FDA’s approval letter for ANDA No. 78-548 explains that the Agency’s “ongoing review” of the requirements for ANDA approval excused the 30-month tentative approval date:

With respect to 180-day generic drug exclusivity, we note that Nycomed was the first ANDA applicant to submit a substantially complete ANDA with a paragraph IV certification to the '944 patent. Therefore, with this approval, Nycomed is eligible for 180 days of generic drug exclusivity for Imiquimod Cream, 5%. . . .  The agency notes that Nycomed failed to obtain tentative approval of this ANDA within 30 months after the date on which the ANDA was filed.  However, the agency has determined that the failure to obtain tentative approval within 30 months was caused by the agency’s ongoing review of the requirements for approval of Imiquimod Cream, 5%, and therefore Nycomed did not forfeit eligibility for 180-day generic drug exclusivity. See section 505(j)(5)(D)(i)(IV) of the Act.

Although FDA received and recently denied to two citizen petitions concerning generic ALDARA Cream (here and here), both petitions were submitted to FDA in July and August 2009.   The 30-month period for ANDA No. 78-548 expired in April 2009, so FDC Act § 505(q)(1)(G) was not implicated. 


  • On March 8th, the U.S. District Court for the District of New Jersey denied Graceway's motion for a temporary restraining order/preliminary injunction in a patent infringement lawsuit filed late last month concerning a newly issued patent that is not Orange Book-listed for ALDARA Cream.  The court noted that the late-filed lawsuit put at risk Nycomed's 180-day exclusivity, which has already been triggered. 
Categories: Hatch-Waxman