A New Wrinkle in Generic ACTOS 180-Day Exclusivity; What Might it Mean for Post-MMA Exclusivity?

By Kurt R. Karst –       

A rather interesting and unexpected (to most) ANDA approval popped up on FDA’s website late last week.  On February 6, 2013, FDA approved Macleods Pharmaceuticals Limited’s (“Macleods’”) ANDA No. 202467 for a generic version of ACTOS (pioglitazone HCl) Tablets, 15 mg, 30 mg, and 45 mg.  What’s interesting is that Macleods is not a first-filer eligible for 180-day exclusivity, and the exclusivity periods for each strength, which were triggered last August, are not over until later this week.  Macleods was able to obtain FDA approval to market its drug product by virtue of a selective waiver of a first-filer’s exclusivity.  According to FDA’s ANDA approval letter:

With respect to 180-day generic drug exclusivity, we note that Ranbaxy Laboratories Limited (Ranbaxy) was a first ANDA applicant to submit a substantially complete ANDA with a paragraph IV certification to the listed patents.  Therefore, Ranbaxy is eligible for 180-day exclusivity for Pioglitazone Tablets USP, 15 mg, 30 mg, and 45 mg. Ranbaxy’s exclusivity was triggered on August 17, 2012, when it commenced marketing an authorized generic of all three strengths of Pioglitazone Tablets, USP.  In a letter dated January 15, 2012, [REDACTED] informed the agency that, with respect to Macleod’s ANDA 202467, [REDACTED] was selectively waiving its rights to 180-day exclusivity effective on February 6, 2012.

(Although the name of the waiving company is redacted in the approval letter, Ranbaxy is the logical choice.) 

As we previously reported (here and here), FDA is embroiled in litigation over 180-day exclusivity for generic ACTOS, which is governed by the version of the statute in effect prior to the December 2003 enactment of the Medicare Modernization Act (“MMA”) when 180-day exclusivity was patent-by-patent.  In October 2012, Judge Amy Berman Jackson of the U.S. District Court for the District of Columbia ruled against FDA in a challenge brought by Watson Laboratories, Inc. (“Watson”), and ordered FDA (for the first time ever) to approve the company’s ANDA No. 076798.  FDA had previously determined that Watson was not eligible for 180-day exclusivity, but that two other companies – Mylan (ANDA No. 076801) and Ranbaxy (ANDA No. 076800) – were eligible for shared exclusivity.  Both FDA and Mylan have appealed the district court decision to the U.S. Court of Appeals for the District of Columbia Circuit, where briefing is well underway but a date for Oral Argument has not yet been scheduled.  (Copies of FDA’s briefs in the case are available here and here; Mylan’s briefs are available here and here; and Watson’s brief is available here.)  As we previously noted, Judge Jackson’s decision, if it stands, seems to have effects on post-MMA 180-day exclusivity insofar as her decision means that a patent amendment to an ANDA does not count for 180-day exclusivity purposes.  Indeed, FDA has made the same connection in its briefing in the case (see here at pages 36-38).

The Macleods ANDA approval also raises an interesting post-MMA issue, and one that we have speculated on before: selective waiver of 180-day exclusivity post-MMA where there are multiple first applicants who might share 180-day exclusivity.  There is still no precedent for this scenario.  Back in June 2010 we commented that “[b]eing a first applicant means that you are the member of an exclusive club.  So to allow a non-member to share in the benefits of club membership, it seems possible that FDA would require all first applicants (whether 1 or 10) to agree in writing that a subsequent applicant should be accorded the benefits of club membership.” 

The Macleods ANDA approval, which, we repeat, concerns pre-MMA exclusivity shared among multiple first filers, might nevertheless inform how FDA might address the issue post-MMA.  In this case, FDA clearly did not seek consent from other first filers concerning Ranbaxy’s selective waiver of 180-day exclusivity.  After some digging, we found two other pre-MMA shared exclusivity cases – one concerning Metformin HCl Extended-release Tablets (see here), and another concerning Topirimate Sprinkle Capsules (see here).  Similar to the selective waiver for Pioglitazone HCl Tablets, there is no indication that consent was sought or obtained in either of those cases.  If FDA ultimately does address the issue of a post-MMA selective waiver of exclusivity shared among multiple first filers and requires consent among all first applicants (or perhaps all eligible first applicants), then the Agency will likely have to explain why the post-MMA world differs from the pre-MMA world in this respect and how the three above-referenced pre-MMA decisions would be differ in a post-MMA world.