AG Schwalb Secures Over $2.3 Million from Suboxone Maker Accused of Monopolizing Opioid Treatment Drug

Bipartisan Coalition of 42 AGs Alleged That Company Used Anticompetitive Scheme to Illegally Profit Off of Opioid Epidemic

WASHINGTON, DC – Attorney General Brian L. Schwalb today announced that Indivior, Inc – which makes the opioid addiction treatment medication Suboxone – will pay the District approximately $2.3 million as part of a 42-state settlement that resolves allegations that the company orchestrated an anticompetitive scheme to block generic competition for Suboxone. The alleged scheme enabled Indivior to extract monopoly profits for Suboxone at the expense of District residents suffering from opioid addiction, who either paid more for Suboxone than they would have without Indivior’s conduct or did not receive the treatment at all.

“The opioid epidemic has left a trail of devastation in its wake, affecting communities far and wide, including the District which has the second highest rate of opioid overdose deaths in the nation,” said AG Schwalb. “In pursuit of higher corporate profit, Indivior sought to illegally block access to less expensive generic medications, making it harder for individuals struggling with addiction to access critical treatment medication. This settlement reaffirms our commitment to using the law to ensure District residents obtain the treatment they need and to hold accountable any company that chooses to put profits over people.” 

In 2016, the Office of the Attorney General (OAG) joined 35 other state AGs in suing Reckitt Benckiser Pharmaceuticals (Reckitt), now known as Indivior, alleging that it conspired with MonoSol Rx to switch branded Suboxone from a tablet version to a film to prevent or delay generic alternatives and maintain Reckitt’s monopoly profits. The lawsuit alleged that this conduct was illegal “product hopping,” where a company makes modest changes to its drug to extend patent protections and takes action to get patients switched to the new drug, so other companies cannot enter the market and offer less expensive but equally effective generic alternatives.

The lawsuit alleged that in 2002, when Reckitt introduced Suboxone in tablet form, it had seven years of exclusivity patent protection, meaning no generic versions could enter the market during that time. Before that period ended, however, Reckitt worked with MonoSol to create a new, patented version of Suboxone as a dissolvable film, similar in size to a breath strip. Reckitt allegedly steered health professionals who prescribed Suboxone from the tablet to prescribe the film through marketing, price adjustments, and other anticompetitive methods. Ultimately, after the majority of Suboxone prescriptions were written for the film, Reckitt removed the tablet from the U.S. market. Reckitt also petitioned the FDA through a process originally meant for private citizens, but which Reckitt used to persuade the FDA to delay approval of generic versions of Suboxone tablets.

Suboxone is used to treat heroin addiction and other opioid addictions by easing addiction cravings. As a result of Indivior’s alleged actions, purchasers have paid artificially high monopoly prices since late 2009, when generic alternatives of Suboxone might otherwise have become available. During that time, annual sales of Suboxone topped $1 billion.

As a result of the AG multistate litigation, Indivior will:

  • Pay the states and the District $102.5 million, of which the District will receive approximately $2.3 million;
  • Stop the type of product-hopping it employed with Suboxone that would similarly extend its monopoly over other drugs; and
  • Notify the states and the District if it applies for a new drug application regarding Suboxone, files a citizen petition, introduces new products, or if there is a change in corporate control – all of which will help the states and DC ensure that Indivior refrains from engaging in the same kind of anti-competitive conduct alleged in the complaint.  

AG Schwalb was joined in this settlement agreement by the Attorneys General of Alabama, Alaska, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, New Hampshire, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Utah, Vermont, Virginia, Washington, West Virginia and Wisconsin. 

The full settlement agreement is available here.

This matter was handled by Assistant Attorneys General Elizabeth Arthur and Amanda Hamilton, and Adam Gitlin, Chief, Antitrust and Nonprofit Enforcement Section.

OAG’s Efforts to Address the Opioid Crisis 
This settlement is the latest development in OAG’s efforts to address the national opioid crisis and protect District residents from harm. In 2018, the DC Council passed a permanent version of the Synthetics Abatement and Full Enforcement Drug Control Act (Safe DC), proposed by OAG, to make it easier to prosecute the suppliers and distributors of dangerous drugs, including the synthetic opioid fentanyl.  

In June 2019, OAG sued Purdue Pharma and former top executive Richard Sackler for misleading patients, doctors, and communities about the danger of opioids in pursuit of massive profits from sales. In July 2020, OAG led a 10-state coalition supporting states’ rights to enact policies geared towards opioid overdose prevention. In February 2021, OAG announced a settlement with McKinsey & Company, one of the world’s largest consulting firms, over its role in turbocharging the opioid crisis by helping opioid manufacturers promote and profit off dangerously addictive painkillers. In April 2021, OAG was a part of a $300 million multi-state settlement agreement with Indivior over Medicaid fraud allegations and the false marketing of Suboxone. In February 2022, OAG secured over $47 million from several opioid distributors and Johnson and Johnson for the role they played in creating and exacerbating the opioid epidemic in the District and across the country.