A class action lawsuit currently pending in the District of Massachusetts alleges that Takeda Pharmaceutical Company engaged in a “pay-for-delay” scheme to keep cheaper generic versions of the constipation drug Amitiza off the market. If you are a third-party payor (TPP)—such as a self-insured employer or a health plan—and paid for Amitiza or its generic counterparts between 2016 and 2024, your legal rights may be affected
What is the Amitiza "Pay-for-Delay" Allegation?
The lawsuit centers on Amitiza (lubiprostone), a brand-name prescription drug used to treat chronic idiopathic constipation and irritable bowel syndrome. Plaintiffs allege that Takeda entered into an unlawful agreement with generic manufacturer Par Pharmaceutical to resolve patent litigation.
According to the legal complaint, Takeda allegedly paid Par to abandon its patent challenges and delay launching its generic version of Amitiza for several years. In exchange, Takeda allegedly promised not to launch its own “authorized generic” to compete with Par once Par finally entered the market. This type of deal, often called a “reverse payment,” is alleged to have stifled competition and forced everyday people and their insurance providers to pay much higher prices than they would have in a competitive market.
How the Alleged Scheme Impacted Drug Prices
In a normal market, the entry of a generic drug usually causes prices to drop significantly as multiple companies compete for customers. However, the lawsuit claims that Takeda’s “no-authorized-generic” agreement ensured that even when a generic finally arrived, competition remained limited.
The plaintiffs argue that this scheme successfully delayed lower-cost generic competition for up to five years. As a result, third-party payors were allegedly forced to pay “supra-competitive” prices—prices significantly higher than what a fair market would dictate—for both the brand-name Amitiza and the generic lubiprostone eventually released.
Who Is Included in the Amitiza Class Action?
The court has recently certified two specific groups, known as “classes,” in this litigation. You may be a member of one or both of these classes if you are a third-party payor (TPP) that purchased or paid for Amitiza or its AB-rated generic versions between October 1, 2016, and March 31, 2024.
1. The Damages Class This group includes TPPs who paid for these medications in specific states, including California, Connecticut (starting Nov. 30, 2020), District of Columbia, Hawaii, Iowa, Maryland (starting Oct. 1, 2017), Minnesota, Nebraska, Nevada, New Mexico, North Dakota, Rhode Island, South Dakota, Utah, West Virginia, and Wisconsin.
2. The Unjust Enrichment Class This group includes TPPs who paid for these medications in a similar list of states, though the effective dates for some states (like California and Connecticut) vary slightly based on specific state laws.
Important Note for Individual Consumers: This particular notice is directed toward Third-Party Payors (like insurance companies and self-funded employer plans). Natural person consumers, pharmacy benefit managers (PBMs), and fully insured health plans are generally excluded from these specific classes.
Understanding Antitrust Laws and Consumer Protection
Antitrust laws are designed to ensure that companies compete fairly, which keeps prices down for everyone. When pharmaceutical companies are accused of “paying for delay,” they are essentially accused of buying off their competition to maintain a monopoly.
The lawsuit asserts that Takeda’s conduct violated various state antitrust and consumer protection laws. By maintaining a monopoly over Amitiza, the plaintiffs allege Takeda and Par shared in hundreds of millions of dollars in extra profits—money that came directly out of the pockets of health plans and the people they cover.
Is There a Settlement Amount Available Now?
It is important to understand that at this stage, there is no money available and no guarantee of a payout. This notice is to inform you that the court has allowed the case to proceed as a class action.
Takeda and the other defendants deny any wrongdoing and maintain that their patent settlements were legal and did not harm competition. The court has not yet decided who is right. A trial is currently scheduled to begin on April 13, 2026, in Boston, Massachusetts. If the plaintiffs win at trial or if a settlement is reached later, class members will be notified about how to claim their share of any resulting fund.
How to Protect Your Rights in This Case
If you fall into the categories described above, you have two primary choices to make right now:
Do Nothing: If you do nothing, you stay in the class. If the plaintiffs win money at trial or through a settlement, you will be notified on how to ask for your share. However, you will be bound by the court’s decisions and give up your right to sue Takeda separately for these same claims.
Exclude Yourself (Opt-Out): If you want to keep your right to sue Takeda on your own regarding these issues, you must “exclude” yourself from the class. If you opt out, you will not receive any money from this specific lawsuit if it is successful.
The deadline to exclude yourself is currently set for June 9, 2026.
Don't Stand Alone Against Pharmaceutical Giants
Litigation against major pharmaceutical companies is complex and can take years to resolve. Class action lawsuits allow everyday people and organizations to pool their resources and hold companies accountable for practices that affect thousands of others.
If you are a representative of a health plan or self-insured employer, you should review your records for Amitiza or lubiprostone payments made during the 2016–2024 period. Keeping these records organized now will make it much easier to file a claim if money becomes available in the future.
