Hagens Berman filed an antitrust lawsuit against Takeda on behalf of a proposed class of direct purchasers of Amitiza and its generic equivalents regarding a patent infringement settlement in which Takeda is alleged to have paid Par to delay the launch of its generic Amitiza product. This delay allegedly resulted in hundreds of millions of dollars in overcharges to the proposed class.
Trial is set for April 13, 2026.

Case Status
Active
Case Caption
IN RE AMITIZA ANTITRUST LITIGATION
Court
U.S. District Court for the District of Massachusetts
Case Number
1:21-cv-11057-GAO; 1:21-cv-11255-GAO
Defendant(S)
Takeda Pharmaceutical Company Limited
Takeda Pharmaceuticals U.S.A. Inc.
Par Pharmaceutical Inc.
File Date
Phone

TAKEDA’S ALLEGED WRONGDOING

The plaintiffs in the class-action lawsuit, FWK Holdings LLC and KPH Healthcare Services Inc., each filed a lawsuit against drugmaker Takeda on behalf of themselves and other direct purchasers of Amitiza and the drug’s generic counterparts.

The lawsuits allege that Takeda settled patent infringement litigation with Par Pharmaceuticals and paid off Par with an anticompetitive “reverse payment” in violation of federal antitrust laws, aptly named “reverse” because Takeda brought the patent suit, yet paid Par in the end.

THE ALLEGED SCHEME AFFECTING AMITIZA

According to the complaint, the alleged reverse payment took the form of Takeda’s promise not to launch a competing authorized generic (AG) version of Amitiza when Par came to market. This no-AG agreement is allegedly manifest through the royalty payment structure in the settlement, which makes it economically irrational for Takeda to launch its own generic product when Par is allowed to do so.

According to the complaint, in exchange for Takeda’s agreement to not bring a competing market to public, Par agreed to drop its patent challenge, forego launching at-risk, and delay coming to market for five and a half years. The Supreme Court forbids such large and unjustified reverse payments.

Defendants attempted to conceal their unlawful agreement through an allegedly superficial reservation in the settlement agreement that Takeda may launch its own authorized generic (AG) product. Recent authority in the District of Massachusetts rejects the argument that such a reservation can absolve anticompetitive conduct manifest through the royalty provisions in the agreement that contradict that reservation.

The complaints allege this no-AG agreement was confirmed in 2021, when Par launched its AG Amitiza product and Takeda did not launch a competing AG.

TOP PHARMA LAW FIRM

Hagens Berman is one of the most successful litigation law firms in the U.S. taking on pharmaceutical companies and has achieved total settlements valued at more than $320 billion on behalf of plaintiffs.

CASE TIMELINE

Hearing on Motions for Summary Judgment
Hearing on Motion for Class Certification

Plaintiffs Oppose Defendants’ Motion for Summary Judgment
Plaintiffs File Motion for Partial Summary Judgment
Plaintiffs Move for Class Certification

The Court Denies in Part Defendants’ Motion to Dismiss

Plaintiffs File their Amended Complaint Filed
Plaintiffs File their Complaint

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