Tris Pharma $7.5 Million Texas Settlement Over Dyanavel XR, What Parents and Patients Need to Know

Tris Pharma, Inc. and CEO Ketan Mehta agreed to pay $7.5 million to the State of Texas to resolve a lawsuit accusing the pharmaceutical company of making misleading claims about the effectiveness of Dyanavel XR, an ADHD medication.

The settlement does not create a consumer class action, settlement fund or claim program. Patients and parents who used Dyanavel XR do not need to submit a claim form to receive part of the $7.5 million because the agreement directs the payment to the State of Texas. The settlement also does not determine that Dyanavel XR is unsafe. (oag.state.tx.us)

The underlying case is State of Texas, ex rel. Tarik Ahmed v. Tris Pharma, Inc. and Ketan Mehta, Cause No. 23-1030, filed in the 71st Judicial District Court of Harrison County, Texas. The executed settlement agreement identifies November 8, 2023, as the filing date of the action.

Quick Facts: Tris Pharma $7.5 Million Texas Dyanavel XR Settlement

Key Fact	Details
Settlement amount	$7,500,000
Defendants	Tris Pharma, Inc. and Ketan Mehta
Plaintiff	State of Texas, ex rel. Tarik Ahmed
Case	State of Texas, ex rel. Tarik Ahmed v. Tris Pharma, Inc. and Ketan Mehta
Cause number	23-1030
Court	71st Judicial District Court of Harrison County, Texas
Drug involved	Dyanavel XR
Legal issue	Alleged misleading promotion and Texas Medicaid fraud
Relevant Texas law	Texas Health Care Program Fraud Prevention Act (THFPA), Tex. Hum. Res. Code Chapter 36
Settlement effective date	August 31, 2026
Consumer claim form	None
Consumer settlement administrator	None identified
Direct payment to Dyanavel XR patients	None provided by the agreement
First payment	$1,875,000 due September 15, 2026
Remaining payments	$1,875,000 plus interest in 2027, 2028 and 2029
Final scheduled payment	August 31, 2029
Admission of wrongdoing	No
Consumer opt-out deadline	None

The settlement agreement says the $7.5 million is payment to the State of Texas and includes attorneys’ fees and expenses for the State and relator. It also requires Texas to allocate a pro rata share to the federal government under applicable state and federal law.

What Texas Alleged Against Tris Pharma Over Dyanavel XR

The Texas Attorney General’s Office said its investigation led to the 2023 lawsuit against Tris Pharma and Mehta.

Texas alleged that Tris Pharma overstated the efficacy of Dyanavel XR and directed sales representatives to make misleading statements to doctors, including healthcare providers participating in Texas Medicaid.

According to the Texas Attorney General, the alleged representations included claims that Dyanavel XR worked significantly faster than competing ADHD medications and provided other benefits that Texas said were not supported. The Attorney General said the representations were made during thousands of sales calls. 

The settlement agreement defines the relevant statute as the Texas Health Care Program Fraud Prevention Act, or THFPA, formerly known as the Texas Medicaid Fraud Prevention Act.

These allegations were never established through a trial verdict. The settlement expressly states that it is a compromise of disputed issues and is not an admission of facts, wrongdoing, a violation of law or liability by Tris Pharma or Mehta. The defendants expressly denied the allegations and liability.

What the Tris Pharma $7.5 Million Settlement Pays Texas

The settlement requires Tris Pharma and Mehta to pay $7,500,000 to Texas.

The agreement describes that amount as non-punitive compensation in full and final settlement of the action and covered conduct. It specifically states that the amount includes attorneys’ fees and expenses for both the State and the relator, Tarik Ahmed.

The agreement also identifies $4,658,040 of the settlement amount as restitution for purposes of Section 162(f)(2)(A) of the Internal Revenue Code. Texas is required to allocate a pro rata share of the settlement to the United States government as required by state and federal law.

That distinction matters for consumers: the $7.5 million is not a $7.5 million pool that Dyanavel XR patients can divide among themselves.

Where the Tris Pharma $7.5 Million Settlement Money Goes

The executed agreement requires the defendants to make the payments to the State of Texas.

It does not establish a process under which individual Dyanavel XR patients or parents submit claims and receive a portion of the settlement.

The agreement also says the defendants cannot direct or influence how Texas allocates the settlement amount.

Because this is a government enforcement action rather than a consumer class settlement, there is no settlement administrator distributing checks to patients.

Is There a Tris Pharma Dyanavel XR Settlement Claim Form?

No.

The executed agreement does not create a consumer claim form, consumer registration process or settlement website for Dyanavel XR users.

You should therefore be skeptical of anyone claiming that you must pay a fee or provide personal information to “claim your share” of the $7.5 million Tris Pharma settlement.

There is no consumer payment process established by this agreement.

Can Dyanavel XR Patients Claim Part of the $7.5 Million Tris Pharma Settlement?

No direct consumer payment is provided under the settlement agreement.

The settlement is between the State of Texas, relator Tarik Ahmed, Tris Pharma and Ketan Mehta. The $7.5 million payment is made to Texas, subject to the allocation provisions in the agreement.

That means a person who took Dyanavel XR should not assume that taking the medication makes them eligible for a settlement check.

There is no eligibility form to complete and no consumer deadline to meet for this settlement.

Does the Tris Pharma Dyanavel XR Settlement Mean Dyanavel XR Is Unsafe?

No.

The Texas settlement concerns allegations about promotional statements, efficacy claims and Texas Medicaid-related conduct. It does not contain a finding that Dyanavel XR is unsafe for patients.

The current FDA prescribing information identifies Dyanavel XR as an amphetamine extended-release medication indicated for treatment of ADHD in patients 6 years and older. The FDA labeling also contains warnings and precautions concerning risks associated with amphetamine stimulants. 

Those FDA safety warnings are separate from the allegations resolved by the Texas settlement.

If a child is currently taking Dyanavel XR, parents should not stop or change the medication solely because of the settlement announcement. Medication decisions should be discussed with the child’s prescribing healthcare professional.

What the Tris Pharma Settlement Says About Individual Consumer Claims

The settlement does not create individual compensation for people who believe Dyanavel XR caused them harm.

At the same time, the agreement’s release provisions are detailed and should not be oversimplified into a statement that every possible private legal claim by every individual has been eliminated.

The settlement specifically reserves certain claims, including claims the State may assert on behalf of individual consumers or state program payors under laws that are not covered by the release. It also reserves certain subrogation rights involving personal injury or property damage arising from use of defendants’ products by Medicaid participants, subject to the agreement’s exclusions.

That does not guarantee that an individual has a legal claim against Tris Pharma. Anyone who believes they suffered a particular injury would need to have the facts, applicable law and filing deadlines evaluated separately.

What the Tris Pharma Settlement Does Not Say About Dyanavel XR

The settlement should not be interpreted as establishing any of the following:

• That Dyanavel XR is unsafe for everyone who takes it.
• That every Dyanavel XR prescription was improperly marketed.
• That every patient suffered harm.
• That every patient is entitled to compensation.
• That the $7.5 million belongs to Dyanavel XR users.
• That patients must file a settlement claim.
• That the settlement is a consumer class action.

The agreement itself says the defendants deny the allegations and that the settlement is not an admission of wrongdoing or liability.

How Tris Pharma Will Pay the $7.5 Million Texas Settlement

The settlement requires four payments.

Payment	Amount	Deadline
First	$1,875,000	September 15, 2026
Second	$1,875,000 + 3.875% annual interest	August 31, 2027
Third	$1,875,000 + 3.875% annual interest	August 31, 2028
Fourth	$1,875,000 + 3.875% annual interest	August 31, 2029

The agreement makes Tris Pharma and Mehta jointly and severally liable for the settlement amount. Interest at 3.875% applies to the second, third and fourth payments from the effective date through payment.

If a scheduled payment remains unpaid, the agreement provides for additional interest provisions, including a 10% annual rate after the specified grace period.

What Happens to the Tris Pharma Lawsuit After the First Payment

The agreement says that within three business days after Texas receives the first $1,875,000 payment, the State and relator are to file a nonsuit with prejudice dismissing the action.

The 71st Judicial District Court of Harrison County retains jurisdiction concerning enforcement of the settlement agreement.

The settlement therefore resolves the underlying action through an agreed payment arrangement rather than a trial verdict deciding whether the allegations were true.

What Texas Families Should Do About the Tris Pharma Dyanavel XR Settlement

For families who simply want to know whether they need to file a claim, the answer is straightforward: there is no consumer claim to file under this settlement.

If your child takes or previously took Dyanavel XR:

1. Do not stop prescribed medication solely because of the settlement.
2. Speak with the prescribing healthcare professional if you have concerns about effectiveness or side effects.
3. Keep relevant prescription and medical records if your child experienced a suspected injury or significant adverse event.
4. Do not pay a third party claiming it can obtain a share of the $7.5 million Texas settlement.
5. If you believe your child suffered a specific injury, have the individual circumstances reviewed separately rather than assuming the settlement provides compensation.

For comparison, readers interested in a completely different pharmaceutical settlement involving consumer payments can review Iowa and the Sandoz $400 Million Generic Drug Settlement, Who Qualifies, How to Claim, and the March 8, 2027 Deadline. That case has a consumer claim process and is not connected to Tris Pharma.

Tris Pharma Dyanavel XR Settlement Key Dates

Date	Event
November 8, 2023	State of Texas, ex rel. Tarik Ahmed v. Tris Pharma, Inc. and Ketan Mehta filed, according to the settlement agreement
August 25, 2026	Relator and defense-side signatures dated
August 31, 2026	Texas signed; settlement became effective
September 15, 2026	First $1,875,000 payment due
October 1, 2026	Texas Attorney General publicly announced the $7.5 million settlement
August 31, 2027	Second payment of $1,875,000 plus interest due
August 31, 2028	Third payment of $1,875,000 plus interest due
August 31, 2029	Fourth payment of $1,875,000 plus interest due

The August 31 effective date is supported by the settlement’s signature pages and its definition of the effective date as the date of the last required signature.

Frequently Asked Questions About Tris Pharma’s $7.5 Million Dyanavel XR Settlement

Is there a Tris Pharma Dyanavel XR settlement claim form?

No. The $7.5 million agreement does not establish a consumer claim form or settlement administrator.

Can Dyanavel XR patients receive part of the Tris Pharma $7.5 million settlement?

No direct payments to Dyanavel XR patients are provided by the settlement. The defendants are required to pay the settlement amount to Texas.

What did Texas allege against Tris Pharma and Ketan Mehta?

Texas alleged that Tris Pharma and Mehta were responsible for misleading promotion of Dyanavel XR, including alleged representations about the drug’s efficacy and speed of action to doctors and Texas Medicaid providers. 

What law did Texas use against Tris Pharma and Ketan Mehta?

The settlement identifies the Texas Health Care Program Fraud Prevention Act, or THFPA, under Texas Human Resources Code Chapter 36.

Did Tris Pharma admit wrongdoing in the Dyanavel XR settlement?

No. The executed agreement states that the settlement is not an admission of facts, wrongdoing, violation of law or liability. The defendants expressly deny the allegations and liability.

What court handled the Tris Pharma Dyanavel XR lawsuit?

The case is State of Texas, ex rel. Tarik Ahmed v. Tris Pharma, Inc. and Ketan Mehta, Cause No. 23-1030, in the 71st Judicial District Court of Harrison County, Texas.

Is the Tris Pharma Dyanavel XR settlement a class action?

No. The case is a Texas enforcement action involving the State of Texas and relator Tarik Ahmed. It is not a consumer class action.

Do Dyanavel XR patients need to opt out of the Tris Pharma settlement?

No. There is no consumer class settlement requiring patients to opt out.

Does the Tris Pharma settlement prove that Dyanavel XR is dangerous?

No. The settlement resolves allegations concerning promotional and Medicaid-related conduct. It does not contain a finding that Dyanavel XR is unsafe.

When will Tris Pharma finish paying the $7.5 million settlement?

The final scheduled payment of $1,875,000 plus applicable interest is due no later than August 31, 2029.

Can someone who believes Dyanavel XR caused an injury bring a separate claim?

The settlement itself does not create a private injury claim or guarantee compensation. Its release and reservation provisions are specific, so a person with an individual injury should not assume either that they automatically have a claim or that every possible claim has been released. The facts and applicable law would need to be evaluated separately.

Sources for the Tris Pharma Dyanavel XR Settlement

• Texas Attorney General — $7.5 Million Tris Pharma Settlement Announcement
• Executed Tris Pharma Settlement Agreement and Release
• FDA — Dyanavel XR Prescribing Information

Important: This article is for general informational purposes and is not legal or medical advice. The settlement resolves disputed allegations and does not constitute an admission of wrongdoing or liability by Tris Pharma or Ketan Mehta.