Indivior Pharmaceuticals, Inc.INDV
Indivior Pharmaceuticals, Inc. Commitments Disclosure
16. Commitments and Contingencies
Commercial Commitments
The Company has non-cancelable manufacturing and supply agreements with various suppliers and contract manufacturing organizations that extend beyond one year. As of December 31, 2025, these agreements require future minimum purchases of approximately $52 million, including $37 million for contract manufacturing services and $16 million for raw materials.
Future minimum payments under these commitments are approximately $31 million in 2026, $14 million in 2027 and $4 million in each of 2028 and 2029. Purchases under these agreements were $49 million in 2025, $70 million in 2024 and $33 million in 2023.
Legal Proceedings and Contingencies
The Company is involved in various lawsuits, claims, and other legal proceedings that arise in the ordinary course of business. These proceedings may involve compliance and trade practices, antitrust, commercial claims, product liability claims, intellectual property rights and securities, among others.
The Company records accruals for loss contingencies associated with legal matters when it is probable that a liability will be incurred, and the amount of the loss can be reasonably estimated. The Company has accrued for these matters and will continue to monitor each related legal issue and adjust accruals as might be warranted based on new information and further developments. Developments in legal proceedings and other matters that could cause changes in the amounts previously accrued are evaluated each reporting period. Amounts accrued for legal contingencies often result from a complex series of judgments about future events and uncertainties that rely heavily on estimates and assumptions including timing of related payments.
Where the amount and timing of the payment is fixed, the obligation is not interest-bearing, and the impact of discounting is significant, these obligations are recorded at their present value, generally using a discount rate appropriate to the obligation or approximating the risk-free rate at the time the Company incurred the obligation.
The Company does not believe that any of the legal matters discussed below, except as otherwise specifically noted, will have a material adverse effect on its financial position or liquidity as the Company believes it has substantial defenses in the matters. However, the outcomes of the Company’s legal proceedings and other contingencies are inherently unpredictable and subject to significant uncertainties. There can be no assurance that there will not be an increase in the scope of one or more of these pending
matters or that any other future legal matters will not be material to Company’s financial position, results of operations or cash flows for a particular period.
Certain ongoing legal proceedings or threats of legal proceedings to which the Company is a party, but in which the Company believes the possibility of an adverse impact is remote, are not discussed in this Note.
Civil Opioid Litigation
The Company was named as a defendant in more than 400 civil lawsuits alleging that manufacturers, distributors, and retailers of opioids engaged in a longstanding practice to market opioids as safe and effective for the treatment of long-term chronic pain to increase the market for opioids and their own market shares for opioids, or alleging individual personal injury claims. Most of these cases were consolidated and are pending in a federal multi-district litigation in the U.S. District Court for the Northern District of Ohio. See In re National Prescription Opiate Litigation, MDL No. 2804 (N.D. Ohio) (the “Opioid MDL”).
Nearly two-thirds of the cases in the Opioid MDL were filed by cities and counties and other government subdivisions (including, in some instances, school districts and hospitals), while a substantial number of cases were filed by private individual plaintiffs, most of whom assert claims relating to neonatal abstinence syndrome (“NAS”).
Following mediation, the Company, the Opioid MDL Plaintiffs’ Executive Committee and certain state attorneys general finalized a settlement agreement dated April 4, 2025 (the “State/Subdivision MSA”). The settlement framework provides a process through which states and their political subdivisions may elect to participate and, if participation thresholds and other conditions are satisfied, would resolve opioid-related claims brought (or that could have been brought) by participating states and participating subdivisions, including cases pending in the Opioid MDL and certain cases pending outside the Opioid MDL.
Following the States’ approval process and an agreed extension of certain settlement milestones, the Company delivered its notice of determination to proceed under the State/Subdivision MSA on January 23, 2026, and received acknowledgments of receipt from the relevant State and Plaintiffs’ leadership contacts. Other than Maryland and its subdivisions (discussed below), all States and their participating subdivisions participated in the settlement. The Company completed the transfer of Year 1 settlement funds from the escrow structure to the settlement fund administrator arrangements by the applicable settlement transfer date of January 29, 2026. The Company has obtained (or is in the process of finalizing and collecting) State Attorney General releases for 49 of 50 states (excluding Maryland) and certain U.S. territories, and the current focus has shifted to the coordinated filing of consent judgments and dismissals in the Opioid MDL. The Master Stipulation of Dismissal as to all MDL plaintiffs that elected to participate in the MSA was filed on February 19, 2026, dismissing with prejudice a total of 254 cases (all brought by subdivisions) against the Company.
The Company separately executed a final settlement agreement dated April 4, 2025, with the Tribal Leadership Committee (the “Tribal MSA”). During 2025, as participation increased, dismissals of tribal cases were filed and granted with prejudice, including global dismissals that brought participation by litigating tribes to 100% among the settling defendants.
As of December 31, 2025, the Company had deposited the first installment of $15 million into escrow accounts in July 2025 in connection with the settlement framework. Of this amount, $0.5 million due to tribes was deposited into a qualified settlement trust account and, during the fourth quarter of 2025, those funds were transferred to the tribes. The remaining $14 million payable to the states was deposited into a separate bank account controlled by the Company and remained in cash and cash equivalents and accrued litigation settlement expenses as of December 31, 2025. These funds were distributed to the states in early 2026.
The Company recorded a related provision of $78 million as of December 31, 2025, reflecting the net present value of the expected payment stream under the settlement framework, inclusive of discounting assumptions applied at period end. See Note 11. Accrued Litigation Settlement Expenses.
The settlement includes injunctive relief obligations applicable to the Company. Those obligations include restrictions and requirements relating to (among other things): (i) limits on certain promotion of oral opioid use disorder (“OUD”) treatment drugs (including SUBUTEX and SUBOXONE tablets/film), but not including SUBLOCADE, (ii) prohibitions on financial reward or discipline tied to volume of OUD treatment drug sales, (iii) prohibitions on sales of opioid products for pain, (iv) lobbying restrictions, (v) requirements for contracting with third parties responsible for monitoring and reporting (including requiring DEA registrations and suspicious order monitoring programs and sharing evidence of diversion with third-party logistics providers), (vi) obligations to provide copies of lawsuits, subpoenas, or civil investigative demands to states upon request, and (vii) annual training requirements for relevant personnel and certain external-facing programs (including sales force and speaker/key opinion leader programs and related communications).
In January 2026, Maryland confirmed it would not join the State/Subdivision MSA as it relates to the Company, reducing the Company’s total settlement commitment under the State/Subdivision MSA by approximately $2 million, reflecting reductions across remediation payments, certain fee components, and cash conversion amounts.
As of December 31, 2025, the Company reduced the Opioid MDL litigation settlement accrual by $2 million (before discounting) to reflect Maryland’s non-participation and recorded a separate litigation settlement accrual of $2 million representing the Company’s best estimate for a settlement with Maryland. Because the Company anticipated reaching a near-term settlement with Maryland, that separate accrual was not discounted.
In January 2026, the Company reached an agreement in principle with Maryland on a separate settlement addressing opioid‑related claims on the same general subject matter as the State/Subdivision MSA. The agreement in principle contemplates that Maryland would receive economic consideration aligned to the multistate framework and settlement product with an aggregate value of $2 million at wholesale acquisition cost, to be made available over a period of time. Maryland has also requested that the Company cover certain settlement administration costs and that the settlement include a process to secure participation and releases from Maryland political subdivisions. The Company is continuing to negotiate definitive documentation and implementation details, and the settlement has not been finalized as of the date of this filing.
The State/Subdivision MSA and the Tribal MSA are not expected to resolve private plaintiff cases against the Company (whether in the Opioid MDL or proceeding separately), including NAS-related claims. As of February, 24, 2026 there are over 130 private plaintiff cases not involving the subdivisions filed against the Company in the Opioid MDL.
Certain opioid-related matters pending outside the Opioid MDL have been stayed or are subject to status conferences, and the parties have sought extensions or continuances in light of the settlement process.
With respect to specific non-MDL cases and proceedings, the Company has previously disclosed: (i) San Miguel Hospital Corp. d/b/a Alta Vista Regional Medical Center v. Johnson & Johnson, et al., No. 1:23-cv-00903 (D.N.M.), which case was dismissed as to Indivior on March 19, 2025. With respect to the West Virginia NAS matters, the plaintiffs filed a notice of appeal in the West Virginia Supreme Court on February 27, 2025. Briefing on this matter was completed in August 2025. As of the date of this filing, there has been no decision by the West Virginia Supreme Court.
The Company has begun its evaluation of all of the claims, believes it has meritorious defenses, and intends to vigorously defend itself in all actions that are not resolved by settlement agreements. Given the status and preliminary stage of litigation in the non-settled matters, no estimate of possible loss for those matters can be made at this time.
False Claims Act Allegations
In August 2018, the U.S. District Court for the Western District of Virginia unsealed a declined qui tam complaint alleging causes of action under the Federal and state False Claims Acts against certain entities within the Company predicated on best price issues and claims of retaliation. See United States ex rel. Miller v. Reckitt Benckiser Group PLC et al., Case No. 1:15-cv-00017 (W.D. Va.). The suit also seeks reasonable attorneys’ fees and costs. The Company filed a Motion to Dismiss in June 2021, which was granted in part and denied in part on October 17, 2023. The relator filed a sixth amended complaint against only Indivior Inc. on December 7, 2023, which Indivior answered on March 18, 2024. Discovery has been stayed pending resolution of certain discovery disputes.
The Company is evaluating the claims, believes it has meritorious defenses, and intends to vigorously defend itself. Given the status and preliminary stage of the litigation, no estimate of possible loss can be made at this time.
U.K. Shareholder Claims
On September 21, 2022, certain shareholders issued representative and multiparty claims against Indivior PLC in the High Court of Justice for the Business and Property Courts of England and Wales, King’s Bench Division. The claims generally allege violations of the U.K. Financial Services and Markets Act 2000 (“FSMA 2000”) by making false or misleading statements or material omissions in public disclosures, including the 2014 Demerger Prospectus, regarding an alleged product-hopping scheme regarding the switch from SUBOXONE Tablets to SUBOXONE Film.
The representative action was struck out in December 2023 and was affirmed on appeal in January 2025. The claimants applied for permission to appeal to the Supreme Court on February 19, 2025. The Company opposed, and the court refused the application on February 27, 2025. On August 8, 2025, the claimants served their Particulars of Claim on Indivior PLC related to the multiparty action. On October 6, 2025, the Company served its Defence. The multiparty action remains pending. The first case management conference has been set for July 23-24, 2026.
The Company has begun its evaluation of the remaining claims, believes it has meritorious defenses, and intends to vigorously defend itself. Given the status and preliminary stage of the remaining litigation, no estimate of possible loss can be made at this time.
U.S. Shareholder Claims
A class action lawsuit was filed against Indivior PLC, Mark Crossley (the former CEO of the Company), and Ryan Preblick (the CFO of the Company) on August 2, 2024, alleging violations of certain U.S. federal securities laws, and the lead plaintiff filed an amended complaint on December 5, 2024, which also named Richard Simkin (the former CCO of the Company) as a defendant. The defendants moved to dismiss. On September 15, 2025, the court granted the motion to dismiss. The defendants did not file an appeal by the deadline of October 15, 2025.
Opiant Stockholder Claims
On November 8, 2023, plaintiff James Litten filed a class action complaint in the Delaware Court of Chancery alleging that former officers and directors of Opiant Pharmaceuticals, Inc. breached fiduciary duties of care, loyalty, and good faith in connection with Indivior PLC's 2022 acquisition of Opiant. The court granted Opiant's motion to dismiss on June 6, 2025. The plaintiff's time to appeal has expired.
Dental Allegations
The Company has been named as a defendant in numerous lawsuits alleging that SUBOXONE Film was defectively designed and caused dental injury, and that the Company failed to properly warn of the risks of such injuries. The plaintiffs generally seek compensatory damages, as well as punitive damages and attorneys’ fees and costs.
Plaintiffs and potential plaintiffs related to these lawsuits generally can be grouped as follows:
Dental MDL Plaintiffs: Approximately 2,000 of these cases, naming more than 25,000 plaintiffs, have been consolidated in multi-district litigation in the Northern District of Ohio. See In Re Suboxone (Buprenorphine/Naloxone) Film Products Liability Litigation, MDL No. 3092 (N.D. Oh.) (the “Dental MDL”).
Dental MDL Schedule A Plaintiffs: One complaint filed in the Dental MDL on June 14, 2024, attached a schedule of nearly 10,000 plaintiffs (the “Schedule A Plaintiffs”). The parties negotiated a tolling agreement for the Schedule A Plaintiffs that would permit plaintiffs’ counsel additional time to investigate issues such as whether any Indivior product was used before determining whether to file individual complaints to be coordinated with the Dental MDL. Plaintiffs have been dismissing Schedule A claimants pursuant to a mechanism provided by the court. As of February 24, 2026, the plaintiffs had reduced the number of Schedule A claimants to approximately 5,400.
State Court Plaintiffs: One complaint has been filed in New Jersey state court, and the parties have agreed to toll the claims of more than 975 other individuals in Delaware, New Jersey, and Virginia. Complaints have not yet been filed on behalf of the tolled individuals.
Product liability cases such as these typically involve issues relating to medical causation, label warnings and reliance on those warnings, scientific evidence and findings, actual/provable injury and other matters.
These lawsuits and claims follow a June 2022 required revision to the Prescribing Information and Patient Medication Guide about dental problems reported in connection with buprenorphine medicines dissolved in the mouth to treat opioid use disorder, which was required by the FDA of all manufacturers of these products.
These cases are in their preliminary stages. Any bellwether trials would not occur until the fourth quarter of 2027 at the earliest.
The Company has been informed by its primary insurance carrier that defense costs for the Dental MDL should be reimbursed now that the Company's self-insurance retention has been exhausted. Additionally, the Company's primary insurance carrier and secondary carriers have issued a reservation of rights against payment of any liability costs. In the event of a liability finding, various factors could affect reimbursement or payment by insurers, if any, including (i) the scope of insurers’ purported defenses and exclusions to avoid coverage, (ii) the outcome of negotiations with insurers, (iii) delays in or avoidance of payment by insurers and (iv) the extent to which insurers may become insolvent in the future.
The Company has begun its evaluation of the claims, believes it has meritorious defenses, and intends to vigorously defend itself. Given the status and preliminary stage of the litigation, no estimate of possible loss can be made at this time.
Proposed class actions based on similar allegations as in the Dental MDL, but also relating to SUBOXONE Tablets, were filed in Quebec and British Columbia against various subsidiaries of the Company, among other defendants, in April 2024. The Company has begun its evaluation of the claims, believes it has meritorious defenses, and intends to vigorously defend itself. Given the status and preliminary stage of the litigation, no estimate of possible loss can be made at this time.
Historical Timeline
| Fiscal Year | Filed | |
|---|---|---|
| 2025 | Feb 26, 2026 | Showing above |
| 2024 | Mar 3, 2025 | |
About Commitments Disclosures
Commitments and contingencies disclosures catalog a company's off-balance-sheet obligations and legal exposures — purchase commitments, guarantee arrangements, pending litigation, and regulatory proceedings. These items represent potential future cash outflows that may not appear as liabilities on the balance sheet until they become probable and estimable.
Key signals: litigation reserves and disclosed loss ranges quantify management's estimate of legal exposure, but unquantified "reasonably possible" losses often represent the larger risk. Watch for changes in language around pending cases — shifts from "remote" to "reasonably possible" or increases in estimated loss ranges signal deteriorating outcomes. Unconditional purchase obligations and take-or-pay contracts create fixed cost structures that reduce operational flexibility. Guarantee arrangements for subsidiaries or joint ventures can create cascading obligations. Compare the total commitment schedule against projected free cash flow to assess whether the company can meet its obligations without additional financing.