AstraZeneca Sues FDA Over Generic SEROQUEL Labeling Carve-Out Issue After FDA Issues Non-Response Citizen Petition Denial

By Kurt R. Karst –      

As we noted at the end of a post earlier this week (see here), we thought a lawsuit against FDA over the approval of generic versions of AstraZeneca’s quetiapine fumarate franchise – i.e., SEROQUEL (quetiapine fumarate) Tablets (NDA No. 020639) and SEROQUEL XR (quetiapine fumarate) Extended-Release Tablets (NDA No. 022047) – might be on the horizon after the Agency issued a March 7, 2012 non-response denial with respect to two September 2011 AstraZeneca citizen petitions concerning labeling carve-out issues for generic versions of the drugs (Docket No. FDA-2011-P-0662 and Docket No. FDA-2011-P-0663).  We just didn’t think the lawsuit would be on FDA’s doorstep so soon. 

On March 12, 2012, AstraZeneca filed a Complaint and a Motion for Summary Judgment Or, In The Alternative, Application For Preliminary Injunction in the U.S. District Court for the District of Columbia saying that FDA’s non-response petition denial violated the Administrative Procedure Act (“APA”) and should be set aside.  AstraZeneca seeks declaratory and injunctive relief, including a preliminarily injunction enjoining FDA from granting final approval for any ANDA for a generic version of SEROQUEL or SEROQUEL XR until the case can be decided on the merits or after Sunday, December 2, 2012 (whichever comes first), and a permanently injunction enjoining FDA from approving any quetiapine fumarate ANDA until after December 2, 2012. 

As we previously reported in our last Generic Drug Labeling Carve-Out Citizen Petition Scorecard update in which we highlighted the AstraZeneca petitions, SEROQUEL and SEROQUEL XR are listed in FDA’s Orange Book with various periods of patent and non-patent exclusivities.  U.S. Patent No. 4,879,288 (“the ‘288 patent”), the pediatric exclusivity for which expires on March 26, 2012, is listed in the Orange Book for both quetiapine drug products and is the date on which some folks anticipate that FDA might approve a generic version of SEROQUEL with labeling that omits information covered by the two periods of “NPP” (New Patient Population) exclusivity from prior NDA supplement approvals of SEROQUEL for the treatment of schizophrenia in adolescents 13 to 17 years of age and the treatment of bipolar mania in children and adolescents 10 to 17 years of age.  The pediatric exclusivity applicable to the two periods of exclusivity coded as NPP expire on June 2, 2013.

SEROQUEL XR is listed in the Orange Book with two patents – the ‘288 patent and U.S. Patent No. 5,948,437 expiring on May 28, 2017 – as well as several periods of 3-year new clinical investigation exclusivity.  Four of those periods of 3-year exclusivity have expired but are subject to unexpired periods of pediatric exclusivity that end on April 8, 2012.  A fifth period of 3-year exclusivity coded as “I-618” and defined in an Orange Book addendum as “ADJUNCTIVE THERAPY IN THE TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)” expires on December 2, 2012 and is not subject to a period of pediatric exclusivity. 

In its citizen petitions and in court filings, AstraZeneca raises issues with the possible omission (or inclusion) in generic drug labeling of, among other things, information in Table 2 of the products’ labeling concerning glucose-related data and information.  AstraZeneca argues that the omission of such information in generic drug labeling would make a generic product less safe or effective for the remaining non-protected conditions of use of SEROQUEL or SEROQUEL XR and that the inclusion of such information would run afoul of the company’s exclusivity rights.  According to AstraZeneca:

FDA has periodically required AstraZeneca to revise its label to include new information concerning the use of Seroquel.  Some of this new information in the Seroquel label is based on Seroquel XR protected data that cannot be included in a generic drug’s labeling until the associated data exclusivity periods have expired.  If FDA were to permit a generic to omit such information from its labeling – after requiring its inclusion in the labeling for Seroquel – the agency would run afoul of the Administrative Procedure Act's prohibition on arbitrary and capricious agency action.  [(Emphasis added)]

FDA has already tentatively approved several ANDAs for generic versions of both SEROQUEL and SEROQUEL XR.

Given FDA’s non-response petition denials, some might have thought AstraZeneca would be in a bind.  There is no substantive, “on the merits” petition decision for them to challenge.   Nevertheless, AstraZeneca filed suit saying that FDA’s failure to provide a substantive decision violates the APA: 

By refusing to grant AstraZeneca's Citizen Petitions, and in departing from its past practices in refusing even to reach the merits of those Petitions, FDA seeks to deprive AstraZeneca of its rights to due process and meaningful judicial review, and to insulate its unlawful conduct from judicial scrutiny under the [APA].  AstraZeneca accordingly seeks a ruling from this Court that FDA is prohibited from granting final approval to any generic version of Seroquel or Seroquel XR until after December 2, 2012, the expiration of AstraZeneca's statutory exclusivity rights protecting clinical data that must be included in the label of any generic version of those products.

AstraZeneca is seeking an expedited briefing schedule.  We’ll keep you updated as the case progresses.