Can individual patients file a claim in the Tracleer settlement?

No. The Tracleer / bosentan settlement is for Third-Party Payors (TPPs) only. The certified class is limited to entities that purchased, paid, or reimbursed for Tracleer or bosentan for consumption by their members, employees, insureds, participants, or beneficiaries. That means health plans, HMOs, insurance companies, self-insured employer health plans, union health and welfare funds, and pharmacy benefit managers acting as authorized agents. Individual patients who took Tracleer are not class members and cannot submit a claim form, even if they paid significant out-of-pocket costs through copays, coinsurance, or deductibles.

Who is a Third-Party Payor (TPP) for the Tracleer class action settlement?

A Third-Party Payor (TPP) is any entity that paid for prescription drugs on behalf of someone else, typically a health plan paying for a member's medication. TPPs in this settlement include health insurance companies, HMOs, self-insured employer health plans, Taft-Hartley union health and welfare funds, multi-employer welfare arrangements (MEWAs), and the third-party administrators (TPAs), administrative-services-only (ASO) providers, or pharmacy benefit managers (PBMs) acting as authorized agents on behalf of those plans. The class form has separate sections for direct TPP class members (Section A) and authorized agents (Section B). Federal and state governmental entities and the defendants' own subsidiaries are excluded.

What is the deadline to file a Tracleer class action claim?

The claim filing deadline is August 3, 2026. Eligible TPP class members must submit a completed Claim Form online or postmarked by that date. The objection deadline is June 2, 2026. The Fairness Hearing is scheduled for July 1, 2026 at 9:30 a.m. before Chief Judge George L. Russell, III in the United States District Court for the District of Maryland, Courtroom 7A in Baltimore. The deadline to exclude oneself from the class has already passed (December 23, 2024).

When will Tracleer settlement payments be distributed?

Payments will be distributed only after the Court grants final approval to the settlement and any appeals are resolved. The Fairness Hearing is set for July 1, 2026. If the Court approves the settlement at that hearing and no appeals are filed, the Claims Administrator A.B. Data, Ltd. would process claims through the August 3, 2026 deadline and then calculate pro rata allocations. Realistic timing for actual payments to TPPs is therefore late 2026 or 2027 if the schedule proceeds without appeals, and longer if appeals are filed.

Tracleer / Bosentan $65 Million Pay-for-Delay Antitrust Class Action Settlement (Third-Party Payors Only)

Q: How much money will my health plan get from the Tracleer settlement?

The exact amount depends on the volume of qualifying Tracleer and bosentan purchases each TPP claimant submits. The $65 million Settlement Fund will be reduced by court-approved attorneys' fees of up to 33 1/3% (approximately $21.7 million), expenses up to $4.5 million, notice and administration costs, and a service award up to $40,000 for the class representative. The remaining net fund is distributed pro rata to eligible TPP class members based on a court-approved Plan of Allocation, weighted by purchase volume. Larger health plans with substantial Tracleer or bosentan claims data will receive larger payouts than smaller plans with minimal claims.

Q: What is bosentan and why is it called a pay-for-delay case?

Bosentan is the generic name for the prescription drug sold under the brand name Tracleer. It is an endothelin receptor antagonist used to treat pulmonary arterial hypertension (PAH), a serious lung condition. The lawsuit alleges that beginning around 2009, Actelion Pharmaceuticals (now part of Johnson & Johnson) refused to sell samples of Tracleer to generic drug manufacturers that needed those samples to conduct bioequivalence testing, a prerequisite for FDA approval of any generic version. Without samples, the generic manufacturers could not file applications to compete with brand Tracleer. The complaint alleges this kept generic bosentan off the U.S. market until June 2019, much later than it would have entered absent the alleged conduct. This 'sample-blocking' theory is sometimes called pay-for-delay or REMS-abuse antitrust litigation.

Q: What states are covered by the Tracleer class action settlement?

The settlement covers TPP purchases made in 31 states, the District of Columbia, and Puerto Rico. Specifically: Arizona, California, Florida, Illinois, Iowa, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Mexico, New York, North Carolina, North Dakota, Oregon, Rhode Island, South Carolina, South Dakota, Utah, Vermont, Virginia, West Virginia, Wisconsin, the District of Columbia, and Puerto Rico. Purchases made outside these jurisdictions do not qualify, for example, mail-order Tracleer shipped to an Alaska address would not be eligible because Alaska is not a covered state.

By Steve Levine

Tracleer bosentan pay-for-delay antitrust class action settlement pharmaceutical lab bioequivalence testing third-party payor

Published: April 29, 2026

Important: Read Before Filing

This Settlement Is for Third-Party Payors Only. Individual Patients Cannot File a Claim.

The certified class is limited to entities that paid for Tracleer or bosentan on behalf of their members, employees, insureds, participants, or beneficiaries. That means health plans, HMOs, insurance companies, self-insured employer plans, union health and welfare funds, and pharmacy benefit managers acting as authorized agents. If you are an individual patient who took Tracleer or bosentan and paid for it through copays, coinsurance, or out-of-pocket costs, you are not a class member in this settlement and cannot submit a claim form.

Status Preliminarily Approved Fairness Hearing July 1, 2026

Settlement Amount $65,000,000 non-reversionary cash fund; remainder paid pro rata to TPPs

Who Qualifies Third-Party Payors Only health plans, HMOs, insurers, self-insured employer plans, union funds

Class Period December 29, 2015 to September 6, 2024 covers Tracleer and generic bosentan purchases in 31 states, DC, and Puerto Rico

Claim Deadline August 3, 2026 objection deadline June 2, 2026; opt-out deadline already passed

What Is the Tracleer / Bosentan Pay-for-Delay Class Action Settlement?

The Tracleer / bosentan settlement resolves a federal antitrust class action captioned Government Employees Health Association v. Actelion Pharmaceuticals Ltd., Case No. GLR-18-3560, pending in the United States District Court for the District of Maryland before Chief Judge George L. Russell, III. The lawsuit alleges that Actelion Pharmaceuticals Ltd., Actelion Pharmaceuticals US, Inc., and Janssen Research & Development, LLC (now part of Johnson & Johnson) unlawfully delayed generic bosentan from entering the U.S. market, causing third-party payors (TPPs) to overpay for brand-name Tracleer and generic bosentan.

The case theory is sometimes described as "sample-blocking" or "REMS-abuse" antitrust litigation. The complaint alleges that beginning around 2009, Actelion refused to sell samples of Tracleer to generic drug manufacturers that needed those samples to conduct bioequivalence testing, a prerequisite to FDA approval for any generic version of a brand drug. Without samples, the generic manufacturers could not file applications to compete with brand Tracleer, allegedly extending Actelion's monopoly on bosentan well beyond what would have occurred in a competitive market.

Generic bosentan ultimately launched in June 2019. The complaint alleges that absent the challenged conduct, generic versions would have launched several years earlier, and TPPs would have paid significantly less for both brand Tracleer and generic bosentan during that period. The defendants deny any wrongdoing, and the court has not decided the merits.

Why Are Only Third-Party Payors Eligible? (Why Patients Cannot File)

This is the question most readers landing on this page will have, especially patients who took Tracleer for pulmonary arterial hypertension and paid significant copays. The answer comes down to how federal antitrust law works in the prescription drug context.

Under U.S. antitrust law, two tiers of plaintiffs typically file in pharmaceutical anticompetitive-conduct cases. Direct purchasers (wholesalers and large retail chains who buy drugs straight from the manufacturer) bring federal Sherman Act claims. End-payors (the entities that ultimately bear the cost of drugs purchased indirectly) bring state-law antitrust and consumer protection claims under the doctrines that flow from Hanover Shoe and Illinois Brick. The certified class in Government Employees Health Association v. Actelion is an end-payor class, but specifically a Third-Party Payor (TPP) end-payor class, not a consumer end-payor class.

Why no consumer subclass? In pay-for-delay and sample-blocking cases, plaintiffs and class counsel often choose to certify TPPs separately from individual consumers because the two groups have different damages models, different state-law variations affecting their claims, and different aggregation problems. TPP damages can be calculated from clean transaction data (NDC code, fill date, amount paid). Consumer damages require reconstructing individual copay structures, deductible status, coinsurance percentages, and plan formulary placement for millions of patients across dozens of insurance plans. Class counsel pursued the cleaner case here, and the court certified the TPP class accordingly.

For an individual patient who took Tracleer, the practical implication is that any economic harm you experienced (in the form of higher copays driven by higher list prices on Tracleer) is not directly compensable through this particular settlement. Whatever recovery your health plan receives, however, indirectly benefits the broader insured population to the extent it influences future premiums or formulary decisions.

Who Qualifies as a Third-Party Payor (TPP) in This Settlement?

The certified class is defined as all entities that, for consumption by their members, employees, insureds, participants, or beneficiaries, purchased, paid, or provided reimbursement for some or all of the purchase price of Tracleer or bosentan, other than for resale, in 31 specified states plus the District of Columbia and Puerto Rico, at any time between December 29, 2015 and September 6, 2024. The TPP class therefore includes:

• Health insurance companies (national, regional, and Blues plans)
• Health maintenance organizations (HMOs)
• Self-insured employer health plans (companies that pay claims directly rather than buying fully-insured coverage)
• Taft-Hartley union health and welfare funds
• Multi-employer welfare arrangements (MEWAs) and association health plans
• Hospital and provider-sponsored health plans
• Third-party administrators (TPAs), administrative-services-only (ASO) providers, and pharmacy benefit managers (PBMs) acting as authorized agents on behalf of any of the above

The class does not include the defendants themselves, defendants' subsidiaries and affiliates, or federal and state governmental entities. Government plans (Medicare, Medicaid, VA, TRICARE, state employee plans) are excluded entirely.

What States Are Covered by the Tracleer Settlement?

The settlement covers TPP purchases in 31 states, the District of Columbia, and Puerto Rico: Arizona, California, Florida, Illinois, Iowa, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Mexico, New York, North Carolina, North Dakota, Oregon, Rhode Island, South Carolina, South Dakota, Utah, Vermont, Virginia, West Virginia, Wisconsin, the District of Columbia, and Puerto Rico.

States not on this list (including Texas, Pennsylvania, Ohio, Georgia, New Jersey, and others) are excluded because their state-law antitrust or consumer protection statutes do not provide indirect-purchaser standing for the kinds of claims alleged in this case. The place of purchase is determined by where the pharmacy is physically located for in-person purchases, or where the prescription was sent for mail-order purchases. A purchase shipped to an Alaska address would not qualify even if the TPP is headquartered in California, because Alaska is not a covered jurisdiction.

How to File a Tracleer / Bosentan Class Action Claim (Filing Tools)

Class Counsel and Settlement Administrator A.B. Data, Ltd. provide four primary filing tools for TPPs and authorized agents. The fastest path for most claimants is the online claim portal, but mail submission is also available. All claims must be postmarked or submitted online by August 3, 2026.

Official Filing Tools

Step 1: Online Claim Form File a Claim Online Recommended for most TPPs and authorized agents
Step 1 (Alt): Blank Claim Form PDF Download Blank Claim Form (PDF) For mail submission; print, complete, and mail
Step 2: Transaction Data Download Filing Template (XLSX) Required Excel format for purchase data submission
Step 3: NDC Reference Download Applicable NDC List (XLSX) Cross-reference your transaction data against accepted NDCs

What Information Do TPPs Need to File a Claim?

Required information for each qualifying purchase or reimbursement transaction:

• Name of the TPP class member
• National Drug Code (NDC) number, cross-referenced against the official accepted-NDC list
• Drug name (Tracleer or generic bosentan)
• Fill date or date of purchase
• Location (state) of purchase
• Location (state) of insured or beneficiary
• Amount paid by the TPP, net of copays, deductibles, and coinsurance

For claims submitted by an authorized agent on behalf of multiple TPP class members, the agent must additionally provide the plan or group name and Federal Employer Identification Number (FEIN) for each transaction, and must possess prior written authorization from each TPP class member on whose behalf the agent files. The Claims Administrator may request additional documentation during the audit process and may reject claims that lack sufficient supporting data.

Acceptable electronic data formats include Microsoft Excel, ASCII flat-file pipe-delimited, tab-delimited, and fixed-width. Class Counsel publishes an exemplar spreadsheet showing the required column structure (linked above).

How Much Money Will My Health Plan Get?

The exact per-claimant amount cannot be calculated until the claim window closes on August 3, 2026 and the Claims Administrator reviews submitted data. The mechanics of the allocation are straightforward, however.

The $65 million Settlement Fund is reduced by court-approved expenses before any TPP distribution. Class Counsel intends to seek attorneys' fees of up to one-third (33 1/3%) of the fund, which would be approximately $21.7 million. Class Counsel will also seek up to $4.5 million in expenses and a service award of up to $40,000 for the named plaintiff Government Employees Health Association. Notice and administration costs paid to A.B. Data, Ltd. come out of the fund as well.

What remains, very approximately $38 to $39 million, is divided pro rata across all eligible TPP claimants based on the amount each TPP paid for Tracleer and bosentan during the class period. A TPP that paid $5 million for Tracleer claims during the period will receive proportionally more than a TPP that paid $50,000. The exact pro rata percentage will depend on total qualifying claims volume.

If any funds remain after all valid claims are processed, those funds will either be redistributed to eligible TPP class members or paid to a non-profit organization (a cy pres recipient), as approved by the court. No remaining funds revert to the defendants. This is a non-reversionary settlement.

Tracleer / Bosentan Pay-for-Delay Case Timeline

Here is the full procedural history of the case from the original complaint through the current preliminary approval and the upcoming fairness hearing.

Case Timeline

Around 2009

Alleged sample-blocking conduct begins

Complaint alleges Actelion refused to sell Tracleer samples to generic manufacturers seeking bioequivalence testing
June 2019

First generic bosentan launches

Complaint alleges this would have occurred years earlier absent defendants' alleged conduct
November 19, 2018

Class action complaint filed

Government Employees Health Association v. Actelion Pharmaceuticals Ltd., Case No. GLR-18-3560, U.S. District Court for the District of Maryland
September 6, 2024

Litigation Class certified

Court certifies the TPP end-payor class and appoints Government Employees Health Association as class representative
December 23, 2024

Class certification opt-out deadline (passed)

TPPs that did not opt out are bound by the certified class
April 3, 2026

Preliminary approval granted; class notice issued Current Phase

Court approves notice plan and Settlement Administrator A.B. Data begins direct mail and publication notice to TPPs
June 2, 2026

Objection deadline

Last day for class members to file written objections to the settlement, fee request, or service award
July 1, 2026 at 9:30 a.m.

Fairness Hearing

U.S. District Court for the District of Maryland, Courtroom 7A, Baltimore; Chief Judge George L. Russell, III presiding
August 3, 2026

Claim filing deadline

Last day to submit claims online or by mail (postmarked)
Late 2026 or 2027 (expected)

Pro rata distributions to eligible TPPs

After final approval and resolution of any appeals; A.B. Data calculates allocations and issues payments

How to Object to the Tracleer Settlement

Class members who disagree with any part of the settlement, the attorneys' fee request, the expense reimbursement, or the service award have the right to file a written objection with the court. Objections must be postmarked no later than June 2, 2026.

A valid objection must be sent to the Clerk of the Court for the U.S. District Court for the District of Maryland and include the case caption (Case No. GLR-18-3560), the objector's name and contact information, proof of class membership, the legal and factual basis for the objection, and a list of any witnesses or exhibits the objector intends to offer. Objectors who want to speak in person at the July 1 fairness hearing must also file a Notice of Intention to Appear by the same June 2 deadline.

Filing an objection does not exclude the objector from the settlement. A TPP can object and still file a claim form. Filing an objection only signals to the court that the class member wants the court to consider concerns before granting final approval. The deadline to opt out of the class entirely was December 23, 2024 and has long since passed.

Is the Tracleer Settlement a Scam? How to Spot Fake TPP Settlement Outreach

Whenever a major pharmaceutical class action settlement is announced, scammers and unscrupulous third parties begin sending unsolicited outreach to plan administrators, benefits managers, and HR departments offering to file claims on the plan's behalf in exchange for a percentage of any recovery. Some of these third-party claim filers are legitimate and provide real value (particularly for small plans without in-house claims-data capabilities). Others are scams. A few signals separate the real settlement from the fakes:

• The only authoritative source for filing instructions is the official case website and the Settlement Administrator A.B. Data, Ltd. Anyone telling you to file through a different portal or pay an up-front fee to a third party to file your claim is not part of the official process.
• The official claim portal is hosted at claimform.tracleerlitigation.com. Always type that URL directly into your browser rather than clicking links in unsolicited emails.
• A real Settlement Administrator never asks for plan banking credentials, ACH authorization in advance of court approval, or up-front fees of any kind. Any communication requesting payment to file is a scam.
• Legitimate third-party claim filing services typically operate on a contingency basis (a percentage of recovery, often 10% to 25%), not an up-front fee. They also provide a written engagement letter describing the scope of services. Be skeptical of any service asking for fees before claim approval.
• Authorized agents filing on behalf of TPP class members must possess prior written authorization from each TPP. If a third-party filer has not asked for written authorization documentation, they are not following the proper procedure described in the claim form instructions.

What Should TPPs and Plan Administrators Do Right Now?

With preliminary approval granted and the claim window open, here is the short checklist for plan administrators, benefits managers, and TPP claims teams:

• Identify whether your plan paid for Tracleer or generic bosentan during the class period (December 29, 2015 through September 6, 2024). The drug treats pulmonary arterial hypertension, a relatively rare condition, so most general-population plans will have limited exposure but plans serving older populations or specialty drug formularies may have significant claims volume.
• Pull transaction data from your PBM or claims processor for both Tracleer (brand) and generic bosentan during the class period, filtered to the 31 covered states plus the District of Columbia and Puerto Rico. Required data fields are NDC, fill date, state of purchase, state of insured, and amount paid net of copays, deductibles, and coinsurance.
• Decide whether to file the claim directly using your in-house claims team or to engage an authorized agent (typically a third-party administrator or pharmacy benefit manager). Either path is acceptable under the Plan of Allocation.
• Download the official filing template and NDC list from the case website (linked above) and confirm your transaction data conforms to the required format before submission.
• File the completed claim online or by mail postmarked no later than August 3, 2026. Late claims will be rejected.
• Track the case docket through PACER if you want real-time updates on the fairness hearing or any post-approval orders. The case is Government Employees Health Association v. Actelion Pharmaceuticals Ltd., Case No. GLR-18-3560, in the U.S. District Court for the District of Maryland.

Lawyers Representing the Class

The court has appointed two firms as Co-Lead Class Counsel: Cohen Milstein Sellers & Toll PLLC (lead attorney Sharon K. Robertson) and Hagens Berman Sobol Shapiro LLP (lead attorney Thomas M. Sobol). Both firms have substantial experience with prescription drug antitrust class actions, including pay-for-delay and sample-blocking matters.

Class members are not personally responsible for paying Class Counsel. Co-Lead Class Counsel will request court approval for attorneys' fees up to one-third (33 1/3%) of the $65 million Settlement Fund plus interest, expenses up to $4.5 million, and a service award up to $40,000 for the class representative Government Employees Health Association. The court will rule on the fee application at or after the July 1, 2026 fairness hearing. Any approved fees, expenses, and service award are paid out of the Settlement Fund.

How Do I Find Class Action Settlements?

Find all the latest class actions you can qualify for by getting notified of new lawsuits as soon as they are open to claims:

Sources

• Official Case Website: Tracleer Litigation Settlement Site
• Official Notice of Class Action Settlement: Tracleer Bosentan Class Action Settlement Notice (PDF)
• Government Employees Health Association v. Actelion Pharmaceuticals Ltd., Case No. GLR-18-3560, U.S. District Court for the District of Maryland, Hon. George L. Russell III presiding

Case Information

OpenClassActions.com is a consumer news site. We report on filed complaints, court orders, and class action settlements. We are not a law firm, we are not Class Counsel, we are not the Settlement Administrator, and we do not process or decide claims. The information in this article is based on the publicly filed Notice of Class Action Settlement, the official case website at tracleerlitigation.com, and federal court records. The defendants deny any wrongdoing, and the court has not decided the merits of the plaintiffs' claims.

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Settlement Snapshot
Status	Preliminarily Approved (April 3, 2026); Fairness Hearing July 1, 2026
Settlement Amount	$65,000,000 (non-reversionary)
Who Qualifies	Third-Party Payors only (health plans, HMOs, insurers, self-insured employer plans, union funds, PBMs as authorized agents). Individual patients are NOT class members.
Claim Form Required?	Yes - online or by mail; postmarked by August 3, 2026
Class Period	December 29, 2015 to September 6, 2024
Covered Jurisdictions	31 states + DC + Puerto Rico (full list in body)
Objection Deadline	June 2, 2026
Claim Filing Deadline	August 3, 2026
Fairness Hearing	July 1, 2026, 9:30 a.m. at U.S. District Court for the District of Maryland, Courtroom 7A
Defendants	Actelion Pharmaceuticals Ltd.; Actelion Pharmaceuticals US, Inc.; Janssen Research & Development, LLC
Case Number	GLR-18-3560
Court	U.S. District Court, District of Maryland
Judge	Hon. George L. Russell, III (Chief Judge)
Class Counsel	Cohen Milstein Sellers & Toll PLLC; Hagens Berman Sobol Shapiro LLP
Settlement Administrator	A.B. Data, Ltd.
Official Website	Tracleer Litigation Site