Overview
On September 27, 2024, End Payors filed a motion for preliminary approval of a $5.5 million settlement in this putative antitrust class action against AstraZeneca Pharmaceuticals LP and Handa Pharmaceuticals.
Plaintiffs allege that AstraZeneca Pharmaceuticals LP struck a pay-for-delay deal with Handa Pharmaceuticals LLC, inducing the generic-drug maker to hold off on launching its generic versions of AstraZeneca’s prescription drug treatment for schizophrenia, bipolar disorder and depression, Seroquel XR, for over a year. In exchange, the class alleges that AstraZeneca committed to stall the launch of its own generic for six months after Handa rolled out its products in late 2016.
Cohen Milstein is Interim Co-Lead Class Counsel for the putative End-Payor Class.
Case Background
As of 2016, Seroquel XR was the eighty-sixth most prescribed medication in the United States, with more than 8 million prescriptions and annual sales exceeding $1 billion.
Plaintiffs allege that Defendants engaged in an illegal scheme to delay competition in the United States and its territories for Seroquel XR, a prescription medication approved by the U.S. Food and Drug Administration (“FDA”) for the treatment of: (1) schizophrenia; (2) acute depressive episodes of bipolar disorder; (3) acute manic or mixed episodes of bipolar disorder in conjunction with other medications; (4) long-term bipolar disorder in conjunction with other medications; and (5) major depressive disorder.
Recognizing the huge market for Seroquel XR, in 2008, Handa became the first drug manufacturer to file an Abbreviated New Drug Application (“ANDA”) (No. 90-482) with the FDA seeking approval to market the 50mg, 150mg, 200mg, and 300mg strengths of generic extended-release quetiapine fumarate tablets, with Seroquel XR as its Reference Listed Drug. Handa later filed an ANDA for the 400mg strength of extended-release quetiapine fumarate.
Pursuant to 21 U.S.C. § 355(j)(2)(B), Handa sent AstraZeneca, the manufacture of Seroquel XR, notice letters, certifying that it would seek final FDA approval to launch and market its generic extended-release quetiapine fumarate product prior to the expiration of U.S. Patent No. 5,948,437 (the “’437 Patent”), a follow-on patent, which supposedly covered Seroquel XR.
The ’437 Patent was set to expire on May 8, 2017 and the regulatory exclusivities associated with the ’437 Patent expired on November 28, 2017.
Plaintiffs allege that AstraZenca sought to block Handa’s generic version of Seroquel XR by filing a patent infringement lawsuit against Handa. In December 2010, after the FDA granted tentative approval to Handa’s ANDA for generic Seroquel XR in all strengths and it became clear that AstraZeneca was very likely to lose any litigation over the ‘437 Patent, Plaintiffs claim that AstraZeneca induced Handa to drop its patent challenge and delay launching its generic version with a large “reverse payment” in direct violation of antitrust law.
On or about September 29, 2011, AstraZeneca and Handa entered into a settlement agreement concerning Handa’s ANDA (“Handa Non-Compete Agreement”). Under the terms of the Handa Non-Compete Agreement, Handa agreed to abandon the patent fight and delay its launch of generic extended-release quetiapine fumarate in the 50mg, 150mg, 200mg, and 300mg strengths until November 1, 2016. Handa also agreed to abandon the patent fight with respect to the 400mg strength as well, even though it did not hold first filer status for that strength. In exchange for Handa’s delayed generic launch, AstraZeneca agreed not to compete with Handa by launching an authorized generic Seroquel XR during Handa’s 180-day exclusivity period.
Plaintiffs further claim that but for the Handa Non-Compete Agreement and AstraZeneca’s large and unjustified payment, Handa and AstraZeneca would have each launched generic versions of 50mg, 150mg, 200mg, and 300mg strengths of Seroquel XR much earlier, and in any event, well before Handa’s November 1, 2016 launch and AstraZeneca’s May 1, 2017 launch. Additional generics would have launched six months after Handa’s generic extended-release quetiapine fumarate launch, likely resulting in lower prices for Plaintiffs and others.
Handa subsequently assigned this unlawful agreement to Par. On November 1, 2016, Par began selling generic extended-release quetiapine fumarate in the 50mg, 150mg, 200mg, and 300mg strengths and Accord began selling 400mg extended-release quetiapine fumarate.
On May 2, 2017 (180 days thereafter) AstraZeneca launched its own authorized generic versions of Seroquel XR in the 50mg, 150mg, 200mg, 300mg and 400mg strengths. Several other generic competitors launched their own versions of Seroquel XR in all strengths in or around May 2017.
Because of the unlawful Handa Non-Compete Agreement and Accord Non-Compete Agreement (together, the “Non-Compete Agreements”), no generic Seroquel XR was available for Plaintiffs and other Class members to purchase in the United States and its territories until November 1, 2016 and, for a period of six months thereafter, there was only one generic available for each strength of Seroquel XR (marketed by Par in the 50mg, 150mg, 200mg, and 300mg strengths and by Accord in the 400mg strength).
Plaintiffs and the proposed Class seek to recover damages, including treble damages, under the state antitrust and consumer protection laws.
In Re: Seroquel XR Antitrust Litigation, No. 1:20-cv-01076-CFC (D. Del.)