Springboarding Off of an HP&M Citizen Petition, Connecticut’s Attorney General Seeks to Dislodge Exclusivity Block on Generic NEXIUM

By Kurt R. Karst –  

Last week, Connecticut Attorney General George Jepsen announced the submission of extensive comments to FDA that press the Agency to “exercise its discretion to immediately waive the 180-day waiting period and approve the sale” of generic versions of AstraZeneca LP’s NEXIUM (esomeprazole magnesium) Delayed-Release Capsules.  The comments, which seek expedited action from FDA, were filed to the Citizen Petition (Docket No. FDA-2014-P-0594) submitted to FDA earlier this year by Hyman, Phelps & McNamara, P.C. (“HP&M”).  (Coincidentally, the comments were filed on the same day the U.S. District Court for the District of Massachusetts issued a 155-page ruling in In Re: Nexium (Esomeprazole) Antitrust Litigation concerning so-called “reverse payment” settlements.) 

HP&M’s petition, which was submitted to FDA on behalf of a client, requests that the Agency determine that Ranbaxy Laboratories, Ltd. (“Ranbaxy”) has forfeited or is not eligible for first-to-file status for any ANDA subject to FDA’s Application Integrity Policy, including valsartan, esomeprazole magnesium, and valganciclovir hydrochloride, and that FDA immediately approve all tentatively approved ANDAs for these drugs and any other tentatively approved drugs for which final approval is blocked by Ranbaxy’s alleged eligibility for 180-day exclusivity (see our previous post here).  The petition drew comments from both Ranbaxy (here) and Teva Pharmaceuticals USA, Inc. (here).

FDA has not yet substantively responded to the HP&M Citizen Petition.  Shortly after it was submitted to FDA, however, the Agency approved Ohm Laboratories Inc.’s (a subsidiary of Ranbaxy) ANDA No. 077492 for Valsartan Tablets with a period of 180-day exclusivity.  In the ANDA approval letter, FDA notes HP&M’s petition:

This petition requests that FDA determine that Ranbaxy has forfeited or is not eligible for first-to-file status for valsartan, among other drugs, and that FDA must immediately approve all tentatively approved ANDAs for which final approval is blocked by Ranbaxy’s alleged eligibility for 180-day exclusivity.  The agency has not made a decision with respect to this petition, and any such decision, when made, will be announced in the petition docket per the usual procedures.  Because ANDA 077492 is eligible for final approval today regardless of the ultimate decision on the issues raised in the petition, today’s action with respect to ANDA 077492 is taken in order not to further delay the availability of generic valsartan while the issues raised in the petition are under consideration.

Nevertheless, other bottlenecks created by Ranbaxy’s first-filer status and alleged eligibility for 180-day exclusivity for other drug products remain.  In his comments to FDA, Attorney General Jepsen says that immediate action is needed on Ranbaxy’s ANDA for generic NEXIUM:

As the only person advocating for the interest of consumers in this forum, and as the Connecticut official charged with protecting the Connecticut citizens from anticompetitive behavior and securing a competitive marketplace, the Connecticut Attorney General believes that [FDA] should either approve promptly [Ranbaxy’s] generic version of delayed-release 40 mg Nexium (esomeprazole) capsules if it is ready for immediate approval, or alternatively rule that Ranbaxy no longer holds the 180-day exclusivity for that product so that other generic drug makers may be approved and enter the market immediately.  The delay in Ranbaxy approval to market esomeprazole has created a bottleneck preventing other potential generic drug entrants from obtaining final approval of their [ANDAs] and beginning to sell lower cost generic esomeprazole.  The resulting harm to all customers – including federal and state government, municipal and employee health plans and the uninsured – leaves these payers no option to choose lower-priced versions of Nexium and flies in the face of the FDA’s stated goals and regulations designed to promote timely access to less expensive generics. 

Among other things, Attorney General Jepsen urges FDA to utilize its “active pursuit” regulation at 21 C.F.R. § 314.107(c)(3) to determine that Ranbaxy is no longer eligible for 180-day exclusivity for generic NEXIUM.  That regulation states that “if FDA concludes that the applicant submitting the first application is not actively pursuing approval of its abbreviated application, FDA will make the approval of subsequent [ANDAs] immediately effective if they are otherwise eligible for an immediately effective approval.”  FDA has never used its authority to enforce 21 C.F.R. § 314.107(c)(3). 

Attorney General Jepsen delves into the relationship between Ranbaxy and AstraZeneca, noting at one point in his comments that “[b]y the first quarter of 2012, Ranbaxy was formulating finished Nexium capsules for purchase by AstraZeneca and booking substantial sales revenue.”  That almost sounds to us like commercial marketing.  And under the statute (FDC Act § 505(j)(5)(b)(iv)(I)), commercial marketing triggering 180-day exclusivity includes “commercial marketing of the listed drug” by a first applicant.  An FDA regulation (21 C.F.R. § 314.107(c)(4)) states that “commercial marketing commences with the first date of introduction or delivery for introduction into interstate commerce outside the control of the manufacturer of a drug product, except for investigational use under part 312 of this chapter, but does not include transfer of the drug product for reasons other than sale within the control of the manufacturer or application holder.”  Hmmmm . . . . .

This is not the first time Connecticut has put Ranbaxy in its crosshair.  In May 2013, Connecticut announced that it joined with other states and the federal government in a settlement agreement to resolve civil and criminal allegations that Ranbaxy introduced adulterated drugs into interstate commerce and, as a result, false or fraudulent claims were submitted to state Medicaid programs, including Connecticut’s Medicaid program.