v3.26.1
Commitments and Contingencies
6 Months Ended
Jun. 30, 2026
Commitments and Contingencies Disclosure [Abstract]  
Commitments and Contingencies
13. Commitments and Contingencies
Legal Proceedings and Contingencies
The Company records accruals for loss contingencies associated with legal matters when it is probable a liability will be incurred and the amount of loss can be reasonably estimated. This note also discusses certain legal matters for which a loss is reasonably possible, including some for which the Company cannot reasonably estimate the amount or range of possible loss, including because the claims remain at an early stage, are not fully developed, or the information necessary to evaluate the claims is not yet available. Adverse outcomes to such litigation, if any, could have a material impact to the Company. Legal proceedings or threats of legal proceedings for which the Company believes the possibility of loss is remote are not discussed in this note.
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:
As of July 24, 2026, approximately 1,967 cases naming approximately 26,307 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 July 24, 2026, the plaintiffs had reduced the number of Schedule A claimants to approximately 4,854.
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 950 other individuals in Delaware, New Jersey, and Virginia. Complaints have not yet been filed on behalf of the tolled individuals.
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.
The MDL cases are in their preliminary stages. Any bellwether trials in the MDL would not occur until the end of the first quarter of 2028 at the earliest.
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 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.
Civil Opioid Litigation
The Company is named as a defendant in a number of 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. Oh.) (the “Opioid MDL”).
As previously disclosed, the Company in January 2026 finalized settlement of all cases involving (i) cities, counties and other government subdivisions of 49 states, including, in some instances, school districts and hospitals, along with the District of Columbia (DC) and (ii) a number of territories; and in 2025 finalized a separate settlement with the tribal nations (collectively, the "Master Settlement Agreements"). The Company separately reached a settlement in principle with Maryland as discussed below, as Maryland and its subdivisions did not join the Master Settlement Agreements. The Master Settlement Agreements include these states, DC, and certain territories along with government subdivisions (upwards of 10,000 subdivisions) and tribal nations that filed suit or never filed suit, and the parties are in the process of filing appropriate materials in the Opioid MDL to release these claims per the settlement agreement. Additionally, the Master Settlement Agreements released certain cases with similar allegations pending outside the Opioid MDL. Those cases have been dismissed or are in the process of being dismissed per the Master Settlement Agreements.
Once the process of dismissing these settled cases per the Master Settlement Agreements is completed (and if the Maryland settlement agreement in principle is finalized), the Company should be a party to only the following cases in the Opioid MDL:
26 cases filed by private individual plaintiffs who have asserted claims relating to neonatal abstinence syndrome ("NAS"). Since a requirement by the court in the MDL to file "fact sheets" related to their cases, over 100 plaintiffs have had their cases dismissed or have dismissed their cases against the Company.
cases filed by one third party payor, one charitable organization and seven individual plaintiffs. In each of these cases the Company is not the only defendant.
The Company expects that all lawsuits outside the Opioid MDL with allegations similar to the Opioid MDL will be dismissed with the exception of the West Virginia NAS matters, where 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.
With respect to the cases still pending that it does not anticipate will be dismissed, the Company has begun its evaluation of all of the claims, believes it has meritorious defenses, and intends to vigorously defend itself. Given the status and preliminary stage of litigation in these cases, no estimate of possible loss for those matters 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 representative action was struck out and affirmed on appeal, so only the multiparty action remains. The claims made in the multiparty action generally allege that Indivior PLC (now known as Indivior Limited) violated 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.
In the second half of 2025, those certain shareholders served their "Particulars of Claim" related to the multiparty action and the Company served its Defence. The parties have exchanged certain limited information related to the Particulars of Claim and the Defence since that time. The first case management conference occurred on July 23-24, 2026, at which the court directed a split trial. The first trial, covering certain matters going to liability (in particular, whether the Company's published information was misleading / contained material omissions, and whether the directors were aware of any such misstatements or omissions), will be scheduled for Q4 2028 for 8 weeks. A decision would not be expected in this trial until the first half of 2029. Following the first trial, if the Company is found liable, the parties would then work to schedule a second trial, which likely would not occur until late 2030 at the earliest. 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.
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.