Indivior PLC (Indivior) operates as a global pharmaceutical company working to help change patients' lives by developing medicines to treat substance use disorders (SUDs).
As a pioneer in developing evidence-based treatments for opioid use disorder, the company’s intention is that the millions of people across the globe suffering from substance use disorders will have access to evidence-based treatment to change lives. As a leader in addiction treatment, Indivior is dedicated to transforming su...
Indivior PLC (Indivior) operates as a global pharmaceutical company working to help change patients' lives by developing medicines to treat substance use disorders (SUDs).
As a pioneer in developing evidence-based treatments for opioid use disorder, the company’s intention is that the millions of people across the globe suffering from substance use disorders will have access to evidence-based treatment to change lives. As a leader in addiction treatment, Indivior is dedicated to transforming substance use disorders from a global human crisis to a recognized and treated chronic disease.
The company’s portfolio of products is available in more than 30 countries worldwide. Its core products include the following approved treatments: SUBLOCADE (buprenorphine extended-release monthly injection); SUBOXONE Film (buprenorphine and naloxone sublingual film); SUBOXONE Tablet (buprenorphine and naloxone sublingual tablets); and SUBUTEX Tablet (buprenorphine sublingual tablets), all of which are treatments for OUD, and OPVEE (nalmefene) nasal spray for opioid overdose reversal.
Product availability varies across the countries in which Indivior treatments are available, including in terms of dosage form, strength and indication.
The company sells its products in the U.S. and in other selected areas of the world, such as much of Europe, Canada, Australia, and through distribution partners in other parts of the world. The company's core geographic market, based on the country where the sale originates, is the U.S., which accounted for 85% of net revenues for the year ended December 31, 2024.
Launch of SUBUTEX Tablets, SUBOXONE Tablets, and SUBOXONE Film in the U.S.
The FDA approved SUBUTEX Tablet (buprenorphine) and SUBOXONE Tablet (buprenorphine/naloxone) in October 2002, and the company launched sales of these products in the U.S. in 2003. Subsequently, in August 2010, the FDA approved SUBOXONE Film (buprenorphine/naloxone) sublingual film, which dissolves more quickly than SUBUTEX and SUBOXONE Tablets. The company discontinued the U.S. distribution of SUBUTEX Tablets in 2011 and SUBOXONE Tablets in 2013.
The company's SUBOXONE Film product faces four generic competitors in the U.S., and a fifth is expected in early 2025. Despite the launches of these generic formulations of tablets and film, as well as branded competition, SUBOXONE Film has maintained a share of the buprenorphine-based opioid use disorder treatment market, by mg volume, of approximately 16% in 2024.
Launch of SUBLOCADE in the U.S.
The FDA approved SUBLOCADE (buprenorphine extended release) injection for subcutaneous use in 2017, and the company launched sales of this product in 2018. As the first long-acting buprenorphine-based injectable approved by the FDA for the treatment of moderate to severe opioid use disorder, SUBLOCADE became the largest product by net revenue for the company by the second quarter of 2022.
Approval and Launch of OPVEE for Overdose Reversal in the U.S.
In May 2023, the FDA approved OPVEE (nalmefene) nasal spray for the emergency treatment of known or suspected opioid overdose induced by natural or synthetic opioids in adults and pediatric patients aged 12 years and older, as manifested by respiratory and/or central nervous system depression. OPVEE (nalmefene) nasal spray is intended for immediate administration as emergency therapy in settings where opioids may be present. OPVEE (nalmefene) nasal spray is not a substitute for emergency medical care. The company acquired OPVEE as part of its acquisition of Opiant Pharmaceuticals, discussed below. It began marketing OPVEE in the U.S. in October 2023.
In September 2023, the company was awarded a contract by the U.S. Biomedical Advanced Research and Development Authority (BARDA) for (i) the procurement of finished, packaged OPVEE held as vendor-managed inventory as a medical countermeasure in the event of a synthetic opioid community or mass casualty event, and (ii) to support FDA-required post-marketing requirement studies, including a three-year stability study to support shelf-life extension, and real-world evidence studies.
Indivior Products
SUBLOCADE Long-acting injectable (buprenorphine) extended-release injection
As the first long-acting buprenorphine-based injectable approved by the FDA for the treatment of moderate to severe opioid use disorder (OUD), SUBLOCADE is a highly differentiated treatment. The company's RECOVER extension study, which was a 24-month observational study of individuals who participated in the Phase 3 SUBLOCADE study, assessed life changes in patients with OUD who received SUBLOCADE as part of a randomized clinical efficacy study. It showed that SUBLOCADE may translate into (1) increased abstinence from illicit opioids compared to placebo; (2) improved patient-reported quality-of-life outcomes (such as health status, employment and insurance status, and healthcare resource utilization); and (3) improved recovery post-treatment. Administration of monthly subcutaneous injections of SUBLOCADE also eliminates the risk of missing daily doses that might result in subtherapeutic plasma levels, potentially leading to relapse to opioid-seeking and opioid-taking behaviors. Finally, because SUBLOCADE may only be administered by a healthcare practitioner via a closed distribution system whereby the patient never has access to the drug, it is expected to reduce the potential for diversion or misuse.
On February 24, 2025, the company announced that the U.S. Food and Drug Administration (FDA) approved label changes for SUBLOCADE, including a rapid initiation protocol and alternative injection sites. Healthcare providers can now initiate treatment with SUBLOCADE after a single dose of transmucosal buprenorphine and a one-hour observation period to confirm tolerability. Additionally, SUBLOCADE can now be administered subcutaneously in the abdomen, thigh, buttock, or back of the upper arm, offering patients and healthcare providers increased flexibility in treatment administration.
The company distributes SUBLOCADE (under the name SUBUTEX Prolonged Release in Europe) primarily in the U.S., Australia, Canada, Finland, Israel, and Sweden.
SUBOXONE Film (buprenorphine and naloxone) sublingual film
SUBOXONE Film was developed through an exclusive agreement with Aquestive (formerly known as Monosol), utilizing its proprietary technology, to deliver SUBOXONE Film in a fast-dissolving sublingual film.
The company’s U.S. sales force ceased promoting SUBOXONE Film as required by the Resolution Agreement with the DOJ and ceased all detailing of the product in 2020, though it remains available for sale.
The company distributes SUBOXONE Film primarily in the U.S., Australia, Canada, Finland, Israel, Italy, Malaysia, and Sweden.
SUBOXONE Tablet (buprenorphine and naloxone) sublingual tablet
SUBOXONE Tablet is a fixed-dose combination of buprenorphine and naloxone in the ratio of four parts buprenorphine to one part naloxone. SUBOXONE Tablet was designed to discourage intravenous abuse of the tablet formulation in patients dependent on full opioid agonists (e.g., heroin and morphine). Naloxone is a potent antagonist at opioid receptors.
SUBOXONE Tablet is distributed primarily in Belgium, Canada, Germany, and the U.K. (the company discontinued distribution of SUBOXONE and SUBUTEX Tablets in the U.S. market in March 2013.)
SUBUTEX Tablet (buprenorphine) Sublingual Tablet
The company distributes SUBOXONE Film primarily in the U.S., Australia, Canada, Finland, Israel, Italy, Malaysia, and Sweden.
SUBOXONE Tablet (buprenorphine and naloxone) is a fixed-dose combination of buprenorphine and naloxone in the ratio of four parts buprenorphine to one part naloxone. SUBOXONE Tablet was designed to discourage intravenous abuse of the tablet formulation in patients dependent on full opioid agonists, such as heroin and morphine. Naloxone is a potent antagonist at opioid receptors.
SUBOXONE Tablet containing 2 mg buprenorphine and 0.5 mg naloxone, and 8 mg buprenorphine and 2 mg naloxone, was approved in the U.S. by the FDA in October 2002 as an orphan drug for the maintenance treatment of opioid dependence. SUBOXONE Tablet is distributed primarily in Belgium, Canada, Germany, and the U.K. The company discontinued distribution of SUBOXONE and SUBUTEX Tablets in the U.S. market in March 2013.
SUBUTEX Tablet (buprenorphine) is available in 0.4 mg, 2 mg, and 8 mg formulations. It was first approved for the treatment of opioid dependence in France in July 1995 and was launched in the French market in February 1996. In April 2003, 2 mg and 8 mg tablets were subsequently approved in the U.S. and launched, but were discontinued from sale in the U.S. market in September 2011. The company primarily distributes SUBUTEX Tablets in Australia, France, Germany, Israel, Norway, Switzerland, and the U.K.
OPVEE (nalmefene) Nasal Spray
On May 22, 2023, the FDA approved OPVEE (nalmefene) nasal spray for the emergency treatment of known or suspected opioid overdose induced by natural or synthetic opioids in adults and pediatric patients aged 12 years and older, as manifested by respiratory and/or central nervous system depression. OPVEE (nalmefene) nasal spray is intended for immediate administration as emergency therapy in settings where opioids may be present. OPVEE (nalmefene) nasal spray is not a substitute for emergency medical care. OPVEE contains 2.7 mg nalmefene.
Nalmefene works quickly by blocking the brain opioid receptors. In a clinical model of opioid-induced respiratory depression in opioid-experienced, non-dependent subjects, OPVEE had an onset of action of 2.5 to 5 minutes and fully reversed respiratory depression as early as 5 minutes after OPVEE administration. Other clinical data include a terminal plasma half-life of approximately 11 hours. While the duration of action of nalmefene is as long as most opioids, a recurrence of respiratory depression is possible.
The company only distributes OPVEE in the U.S.
Discontinuation of Marketing and Promotion of PERSERIS
In July 2024, the company discontinued the marketing and promotion of PERSERIS due to impending market changes that would make the product no longer financially viable. The company has continued to supply PERSERIS to avoid disruption to patient care but no longer deploys a dedicated sales force.
Pipeline
The company's research and development activities are focused on building on its leadership position in the treatment of opioid use disorder (OUD). However, the company's pipeline reflects only potential products, and any product requires the completion of clinical trials to demonstrate safety and efficacy, as well as approval by the FDA.
INDV-2000 Selective Orexin-1 Receptor Antagonist
The company is developing INDV-2000 (Selective Orexin-1 Receptor Antagonist) as a non-opioid treatment for moderate to severe opioid use disorder (OUD). On June 10, 2024, the company announced the dosing of the first subject with INDV-2000 in a Phase 2 double-blind, placebo-controlled, randomized, dose-ranging study to assess the safety and efficacy of INDV-2000 over three months in treatment-seeking individuals with OUD. The purpose of this proof-of-concept study is to measure safety and efficacy and to determine the dose-response relationship for INDV-2000 in participants with moderate to severe OUD who are treatment-naïve, have recently initiated or completed short-term medically supervised opioid withdrawal with transmucosal (TM) buprenorphine, and are interested in transitioning to a non-opioid treatment. The company expects this study to be completed by the end of 2025. The U.S. patents for INDV-2000 expire in 2037.
INDV-6001 Sustained Release LAI Prodrug of Buprenorphine
INDV-6001 is potentially the first three-month LAI buprenorphine for the treatment of OUD. In 2023, the company secured global rights from Alar Pharmaceuticals to develop, manufacture, and commercialize INDV-6001 and a portfolio of buprenorphine-based LAI. The licensor would be entitled to potential milestone payments upon the achievement of various developmental, regulatory, and commercial goals, and entitled to royalties in the low double digit to mid-teens as a percentage of net revenue. The U.S. patents for INDV-6001 expire in 2039.
In September 2024, the company commenced a multiple dose clinical Phase 2 pharmacokinetic study, which it expects to complete by the end of 2025.
Decision to Not Exercise Option For AEF0117 Aelis
On September 4, 2024, the company noted Aelis Farma's announcement of the results from its clinical Phase 2B trial with AEF0117, a synthetic CB1 specific signaling inhibitor designed to treat cannabis-related disorders. This clinical Phase 2B study was part of the strategic collaboration between Aelis Farma and Indivior, which included an exclusive option for Indivior to license the global rights to AEF0117. The study was designed to evaluate the efficacy and safety in treatment-seeking participants with moderate to severe Cannabis Use Disorder.
Manufacturing
The company sources a large portion of its active pharmaceutical ingredients (API) from its own manufacturing facilities.
The API used in the company's buprenorphine products is manufactured at its Fine Chemical Plant (FCP) located in Hull, United Kingdom. FCP manufactures the buprenorphine HCl API used in the manufacture of SUBOXONE Film, SUBUTEX Tablet, and SUBOXONE Tablet, as well as the buprenorphine base API used in the formulation of SUBLOCADE long-acting injection. Historically, a third party has manufactured the buprenorphine base, but the FCP will be capable of manufacturing the base beginning in 2025. FCP has the capacity to produce all of the company's buprenorphine-related requirements, with approximately 25% demonstrated capacity remaining.
The company procures the naloxone HCl active pharmaceutical ingredient mainly from a single supplier for both SUBOXONE Tablet and SUBOXONE Film, although this ingredient is readily available from other suppliers.
The company procures the active ingredient (nalmefene HCl) and the absorption enhancer (dodecyl maltoside) for OPVEE from single suppliers.
SUBLOCADE
SUBLOCADE (buprenorphine extended-release) injection for subcutaneous use is manufactured under an agreement with Curia. The company provides the buprenorphine base, polymer, and syringe assembly used in the manufacture of SUBLOCADE. Curia has two manufacturing facilities located in Burlington, Massachusetts, and Albuquerque, New Mexico. Manufacture of all SUBLOCADE output for the U.S. and Canadian markets is approved at both facilities, while output intended for the Most of World is approved only at the Burlington facility. The company plans to obtain approval to manufacture SUBLOCADE for the Most of World at the Albuquerque facility.
In addition, the company is improving its Raleigh Manufacturing Facility to potentially manufacture SUBLOCADE, thereby better securing its long-term supply. However, it will take time and investment in equipment and validation testing before the company can make regulatory submissions to gain approval for the commercial manufacture of SUBLOCADE at this site.
The company relies on third parties to manufacture and package its products, as well as to perform quality assurance and quality testing.
SUBOXONE Film
SUBOXONE Film is manufactured under an exclusive license and supply agreement with Aquestive Therapeutics. Under the terms of the agreement, Aquestive is the exclusive global manufacturer and primary packager of SUBOXONE Film and is prohibited from developing any other film product containing buprenorphine without the company's written consent. The company provides both the buprenorphine HCl and the naloxone HCl used in the manufacture of SUBOXONE Film.
Aquestive has two manufacturing facilities located in Portage, Indiana. Manufacturing and primary packaging of all SUBOXONE Film output for most markets is approved at both facilities.
SUBOXONE and SUBUTEX Tablets
The company contracts with RB to manufacture SUBOXONE and SUBUTEX Tablets. The company provides both buprenorphine HCl and naloxone HCl used in the manufacture of SUBOXONE and SUBUTEX Tablets. RB manufactures and performs the packaging of all SUBOXONE and SUBUTEX Tablets globally at its facility in Hull, United Kingdom.
OPVEE (nalmefene) nasal spray
The company has contracted for the commercial supply of OPVEE with Kindeva Drug Delivery (formerly Summit BioSciences). SpecGx LLC provides the nalmefene HCl, and Aegis Therapeutics, LLC provides the dodecyl maltoside, an absorption enhancer, used in the manufacture of OPVEE.
Additional Manufacturing and Distributions Processes
The company outsources to third parties certain aspects of the manufacturing and distribution process, including packaging its products with tamper-evident pouches or child-resistant components, in serialized cardboard cartons, and securely storing products, fulfilling orders, and providing other customer service functions.
Sales, Marketing and Distribution
The company's sales, marketing, and distribution processes for its products begin with a focus on the patient. Its products are intended for patients who suffer from opioid use disorder (OUD) or opioid overdose, each a highly stigmatized disease or disease state. These patients are found not just in private physician offices, but also in emergency rooms, hospitals, addiction or rehabilitation centers, outpatient health services, and frequently, as part of their journey with addiction, as incarcerated individuals in the criminal justice system. Accordingly, the company focuses its sales and marketing efforts not just on physicians in private practice but also on healthcare providers situated in these diverse treatment environments.
The company’s sales, marketing, and distribution efforts vary by market.
The United States
The company derives approximately 85% of its net revenues, and an even larger portion of its profitability, from the U.S. market. Unlike many markets in the Most of World, the U.S. market is not a single payor market. Instead, the company's activities are directed at a patchwork of federal and state agencies, organized health systems, criminal justice systems, and healthcare providers who provide treatment and assistance for patients suffering from opioid use disorder (OUD).
Organized Health Systems (OHS)
Many patients who use the company's products are found at outpatient health services (OHS), such as health systems, including hospitals and addiction treatment centers. OHS are an important channel for the company's products because they have the resources and administration to appropriately handle controlled substances that are prescribed, delivered, and stored, and are equipped to administer the requirements applicable to its products, including Risk Evaluation and Mitigation Strategies (REMS). The company's account teams call on key decision-makers at OHS to expand access to its products. The goal is to ensure access to its products by establishing treatment protocols, both medical and logistical, removing barriers to access, gaining formulary access where needed, and ensuring that protocols are in place to comply with applicable DEA, state, and local requirements regarding the storage of controlled substances. As part of this process, the sales team focuses on effectively communicating the scientific rationale and the benefits of its products to healthcare providers, appropriately balanced with safety information. Additionally, the account teams and medical team focus on educating key decision-makers about potentially better adherence, increased continuity of care, and overall cost and resource optimization in the total treatment plan.
Criminal Justice Systems (CJS)
The company also has dedicated teams for customers in the criminal justice system (CJS), including various types of prisons, such as state departments of corrections, county jails, and federal prisons, along with specialty treatment courts. A specialty treatment court is a court with expertise in substance use disorders that may offer alternative and deferred prosecution arrangements for appropriate individuals.
For prisons, the company's dedicated teams attempt to increase access to its products, overcome logistical barriers to care, and promote particular products, but do not call on healthcare providers behind the walls of the prisons.
For specialty treatment courts, the company's Criminal Justice Access Directors, including approximately 46 trained and experienced professionals, educate judges, prosecutors, social workers, and patients about the benefits of its products. The patient is ultimately referred to a healthcare provider (HCP), either in a private office or federally qualified health center, where the decision to use medication for opioid use disorder (OUD), such as SUBLOCADE, is made by the patient with the assistance of their HCP. At these referral sites and locations, the company's sales personnel coordinate with the HCPs and their staff to ensure understanding of the scientific rationale and the benefits of its products, appropriately balanced with safety information.
Commercialization Activities
The company's commercial activities in the U.S. are focused on SUBLOCADE long-acting injectable and OPVEE nasal nalmefene spray. Its sales force does not promote SUBOXONE Film in the U.S. The sales organization in the U.S. comprises approximately 255 trained and experienced pharmaceutical professionals, referred to as Clinical Specialists, who are managed by Area Sales Directors. Clinical Specialists act as a vital link between the various stakeholders within the addiction community, including key opinion leaders, counselors, treatment advocates, pharmacists, nurses, and healthcare providers in specialized treatment centers.
The company's Clinical Specialists are supported by dedicated and experienced professionals in its managed care group who create access to treatment for patients by partnering with the U.S. commercial payors and federal, state, and local governmental payors.
OPVEE
The company's commercialization strategy for OPVEE includes ensuring access to OPVEE via inclusion in state standing orders, enabling public funding, establishing relevant state emergency medical protocols, and securing adjustments to state Good Samaritan laws, through the work of its government affairs and medical teams.
In September 2023, the company was awarded a contract by BARDA for the procurement of finished, packaged OPVEE held as vendor-managed inventory as a medical countermeasure in the event of a synthetic opioid community or mass casualty event. The role of BARDA is to supplement state and local supplies during public health emergencies. The contract also includes options for purchases and delivery of OPVEE over 10 years at guaranteed pricing through 2033.
Advocacy, Education, and Patient Support
The company collaborates with patient organizations, stakeholders, and policymakers to achieve its vision that the millions of people across the globe suffering from substance use disorders (SUDs) will have access to evidence-based treatment to change lives. Its advocacy agenda focuses on expanding access to treatment, advancing treatment equity, and increasing focus on patients in correctional settings.
The company's educational and engagement efforts have focused on expanding the availability of treatment options beyond the clinical setting in the U.S. in order to give patients the flexibility to receive appropriate treatment in the privacy of a physician’s office.
The company also advocates for access to evidence-based treatment in correctional settings to ensure that resources are focused where challenges are greatest.
The company has various programs to help patients access its products. For example, it sponsors a commercial co-pay assistance program that helps patients meet co-payment obligations imposed by their commercial insurance.
Additionally, the company sponsors an insurance reimbursement hub to facilitate the dispensing of its products. Healthcare providers (HCPs) and pharmacies may access this hub via telephone to confirm coverage and the level of benefits. The company also provides patient access specialists to problem-solve access issues, coverage, and coding after a product has been ordered.
There has been enhanced scrutiny of company-sponsored patient assistance programs, both from government enforcement and payors.
Medical Affairs Team
The company's Medical Affairs Team supports healthcare providers (HCPs) and health administrators and includes Medical Science Liaisons and Medical Outcomes Value Liaisons responsible for responding to unsolicited off-label questions, clarifying data related to its products, working with study investigators, and developing and delivering real-world evidence regarding the usage and potential benefits or risks of a medical product derived from an analysis of real-world data. The Medical Affairs team is separate from sales and marketing.
Marketing
The company's marketing efforts are focused on reaching the sufferers of the diseases that its products treat and the healthcare providers (HCPs) who treat them. In each of its markets, the company's commercial activities are supported by strategic planning, business analytics and measurement, and quarterly territory plans, ensuring that each market and sales territory is effectively resourced to maximize market access and to increase the appropriate use of its products.
In the U.S., the company's marketing team is responsible for developing marketing and sales materials, product websites, conference presentations and presence, and media plans, which are reviewed by its Promotions Review Committee (PRC) consisting of medical, regulatory, and legal team members to assess compliance with rules and regulations as appropriate. The company also provides reimbursement support for its U.S. markets. Additionally, it has established strong marketing expertise in increasing disease state and treatment awareness, embedded in various platforms, including digital and traditional media. The company employs third-party vendors, such as advertising agencies, market research firms, and suppliers of marketing and other sales support-related services, to assist with its commercial activities.
Distribution
The company distribute its products in more than 30 countries. The distribution of the company's buprenorphine products is more complicated than that of other specialty pharmaceutical products because buprenorphine is regulated in the U.S. as a Schedule III drug by the FDA and is similarly restricted by law enforcement authorities in the Most of World. Additionally, certain products, like SUBLOCADE, utilize a restricted delivery network. To ensure proper administration, SUBLOCADE may only be administered by a healthcare provider (HCP) and is not dispensed directly to the patient. To ensure that its products are available to HCPs and patients, the company utilizes specialty distributors and a network of several hundred specialty pharmacies that are equipped to adhere to these special requirements.
In contrast, SUBOXONE Film may be dispensed directly to a patient by a pharmacy with an appropriate DEA license. Accordingly, a substantial portion of the company's sales are to pharmaceutical wholesalers, specialty pharmacies, and distributors who, in turn, sell its products to pharmacies, hospitals, and other customers, including federal and state entities.
The company's three largest customers, which are wholesale pharmaceutical companies in the U.S., accounted for 55% of global net revenues in 2024. Its largest customer in each year accounted for 19% of its net revenues in 2024. These customers are the primary purchasers of SUBOXONE Film in the U.S., and as sales of SUBLOCADE grow, which is sold mostly through specialty pharmacies and specialty distributors, the relative importance of these three largest customers declines. The company's fourth largest customer is one of these specialty pharmacies.
Logistics
The company uses central third-party logistics and warehouses that comply with applicable local regulations for the storage and distribution of its products into the supply chain. Its third-party logistics provider specializes in integrated operations that include warehousing and transportation services that can be scaled and customized to the company's needs based on market conditions and the demands and delivery service requirements for its medicines and materials. Their services eliminate the need to build dedicated internal infrastructures that would be difficult to scale without significant capital investment. The third-party logistics provider warehouses all medicines in controlled FDA-registered facilities in the U.S., or in facilities that meet applicable requirements outside the U.S. Orders are prepared and shipped through an order entry system to ensure adequate supply and delivery of the company's medicines.
Most of World
The company's commercial activities are focused on SUBLOCADE long-acting injectable (also called SUBUTEX Prolonged Release), SUBUTEX Tablet, SUBOXONE Tablet, and SUBOXONE Film. Depending on the size and demands of the relevant markets, dedicated teams of clinical liaisons, health policy liaisons, or a combination of both, work to accelerate access to treatment for patients.
In Canada and in approved markets in Europe and Australia, the company has a field force of sales specialists. In markets where these products are either not approved or cannot be promoted under local regulations, the company has medical affairs personnel responsible for responding to medical information requests and for providing information consistent with local treatment protocols regarding such products. These medical affairs personnel are separate from sales and marketing personnel. In certain European markets, the company has a sales team and a separate team of medical science liaisons supporting its rolling launches of SUBLOCADE and SUBOXONE Film.
Outside the U.S. and Europe, the company directly markets SUBLOCADE, SUBOXONE Film, and SUBOXONE Tablets in Canada; and SUBLOCADE, SUBOXONE Film, and SUBUTEX Tablets in Australia. The company also utilizes distributors in certain markets outside the U.S. where the company does not market its products directly.
Research and Development
The company’s research and development expenses were $107 million in 2024.
Intellectual Property
Licensed Technology
The company owns Patent No. 11,458,091, which includes claims covering combinations of nalmefene and Intravail (dodecyl maltoside, an absorption enhancer) in a nasal formulation, which expires in 2038.
Regulation
In the U.S., the company must comply with laws, regulations and other requirements promulgated by numerous federal and state authorities, including the FDA and other agencies and divisions of the Department of Health and Human Services, the Drug Enforcement Agency (‘DEA’), and other agencies of the DOJ, the Consumer Product Safety Commission, the Environmental Protection Agency, the U.S. Bureau of Customs and Border Protection (the ‘CBP’), and state agencies, such as boards of pharmacy.
The company must comply with the FCPA worldwide and similar anti-bribery laws in non-U.S. jurisdictions, such as the U.K. Bribery Act of 2010, which generally prohibit companies and their intermediaries from making improper payments to non-U.S. officials for the purpose of obtaining or retaining business.
After the U.S. and Europe, the company’s largest markets are Canada and Australia, where the company markets its products pursuant to standards set by Health Canada and the Therapeutic Goods Administration, respectively.
History
Indivior PLC was incorporated under the laws of England and Wales in 2014.
