Last month, attorneys general from 35 states and the District of Columbia joined in a lawsuit against Reckitt Benckiser and Indivior, past and present manufacturers of Suboxone, for violating the federal Sherman Act and state laws. Counts include conspiracy to monopolize and illegal restraint of trade. In the suit, the attorneys general ask the court to stop the companies from engaging in anticompetitive conduct, to restore competition and to order appropriate relief for consumers and the states, plus costs and fees.

The case is being led by the AGs from Pennsylvania and New York.

The lawsuit, filed Sept. 23 in the U.S. District Court for the Eastern Division of Pennsylvania, accuses the companies of blocking generic competitors in a move that ended up with consumers paying unnecessarily high prices for the medication.

The lawsuit accuses Indivior, which is the company Reckitt Benckiser spun off in 2014 (see ADAW, Nov. 24, 2014), of conspiring with MonoSol Rx in the switch from a tablet to a film, for the purpose of extending its patent and keeping a monopoly.

Reckitt first introduced Suboxone, which had been paid for by the federal government as an orphan drug, in 2002 as a tablet. That patent lasted for seven years. But before that period ended, Reckitt created the film with MonoSol and converted its consumers to the film, the lawsuit alleges. Reckitt then removed the tablet from the market, alleging pediatric exposures.

Background

The patent shenanigans have been known about and documented for more than three years. Now there are other alternatives, and patients who find their Suboxone no longer covered can easily switch to one of the other forms of buprenorphine-naloxone. They are bioequivalent.

There are now three branded versions of buprenorphine-naloxone: Suboxone, which is a film that dissolves in the mouth, and Bunavail and Zubsolv, which are tablets that dissolve in the mouth. (Oral buprenorphine-naloxone will not be effective unless dissolved in the mouth.)

ADAW covered Reckitt’s development of the film. The company tried hard to get its film on formularies, so physicians — whom the company was detailing heavily — could prescribe it instead of the tablets (see ADAW, May 30, 2011). The claim was always that the new product was needed to respond to the growing opioid epidemic. A Reckitt spokeswoman at the time told us that Reckitt “began to discuss the development of Suboxone Film with MonoSol in early 2006 in response to these public health and patient needs.” Reckitt, in a 2010 press release, boasted about its market share with the film.

The Food and Drug Administration (FDA) was on to Reckitt by 2013, when it soundly rejected the manufacturer’s request that all generic competition to Suboxone be designed to limit pediatric exposure (in other words, be film, which it had the patent on). At the same time, the FDA approved two generic competitors, and asked the Federal Trade Commission (FTC) to investigate the company for anticompetitive practices related to its efforts to protect its patent on Suboxone (see ADAW, March 4, 2013). The FTC investigation is ongoing; in fact, Sen. Edward J. Markey (D-Massachusetts) wrote the FTC last week urging that this investigation be stepped up. Senator Markey is a supporter of increasing the number of patients who can be seen by a buprenorphine-certified physician.

States

Here are some of the comments from the states filing the lawsuit:

Hawaii: “Helping addicts recover from the deadly effects of opioids is a top priority here and in other states. This week I had commented on the legal authority in Hawaii to prescribe Suboxone for the purpose of opioid detoxification or maintenance treatment of opioid dependence. Unfortunately, the makers of this drug have capitalized on this serious public health crisis and raked in huge corporate profits.” (Attorney General Douglas Chin)

New York: “My office will not permit drug companies to engage in anticompetitive conduct that unlawfully extends their monopolies — and their monopoly profits — on drugs. We will take decisive action against drug companies that engage in schemes to manipulate the cost and availability of treatment options to maximize corporate profits. Opioid abuse is a public health crisis, and opioid-dependent patients should have access to the most affordable addiction treatment options available.” (Attorney General Eric Schneiderman)

Kentucky: “Substance abuse is the single greatest threat to our Commonwealth. For these companies to allegedly try and monopolize the market on a treatment drug is beyond belief and borderlines on inhuman. In Kentucky, drugs are killing our children, destroying our families and scarring our neighborhoods. It is also the single greatest threat to job growth.” (Attorney General Andy Beshear)

Maine: “It is difficult to overstate the effects of artificially inflating the cost of a drug that could ease Maine’s opiate addiction epidemic. People will quite literally die because they cannot afford an effective form of treatment. It is unconscionable that in the midst of an epidemic this would be happening. I look forward to working with my colleagues in these other states to hold this manufacturer accountable.” (Attorney General Janet T. Mills)

Virginia: “For many Virginians struggling with an addiction to heroin and other opioids, Suboxone can be an important part of a treatment plan that allows them to manage their substance abuse disorder. After extensive investigation, my colleagues and I have reason to believe that these monopoly practices violated the law and made this important medication more expensive and more difficult to obtain. I will continue to attack the heroin and prescription opioid crisis with every tool at my disposal and will not hesitate to take action against those who contribute to the problem, no matter who they are.” (Attorney General Mark Herring)

Ohio: “Some people rely on this prescription drug to treat heroin addiction. They shouldn’t be forced to pay higher prices or deprived of options because drug makers circumvent the law to maximize their profits. People deserve the benefits of fair market competition. When the product involved is used to treat addiction, the implications are even more significant.” (Attorney General Mike DeWine)

Alabama: “Antitrust laws exist to protect consumers from unscrupulous trade practices that stifle fair competition. This lawsuit seeks to stop Indivior from doing so, and to provide relief for consumers who were harmed.” (Attorney General Luther Strange)

California: “When prescription drug companies unlawfully manipulate the marketplace to maximize profits, they put lives at risk and drive up the cost of health care for everyone.” (Attorney General Kamala Harris)

Massachusetts: “We allege these drug makers unlawfully delayed and undermined competition for Suboxone. Companies that game the system to profit from the opioid epidemic and limit access to generic alternatives must be held accountable.” (Attorney General Maura Healey)

Utah: “This is a crucial drug to combatting opioid addiction and abuse, which has grown to epidemic proportions in our state and nation. This lawsuit seeks to restore competition, which is always good for the consumer, especially when it comes to pricing. We feel it is yet another way our office can stand up for the average citizen.” (Attorney General Sean Reyes)

Attorneys general of the following governments joined in the lawsuit: Alabama, Alaska, Arkansas, California, Colorado, District of Columbia, Connecticut, Delaware, Florida, Hawaii, Illinois, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Utah, Vermont, Virginia, Washington and Wisconsin.

Indivior responds

Virginia-based Indivior responded last week to the civil complaint. The company takes the allegations “seriously,” and intends to defend against them and to cooperate with government investigations.

“Indivior is assessing this matter, the Federal Trade Commission and Department of Justice investigations, the private class action and other litigations to determine the implications to the provision on the Company’s balance sheet for such matters,” the company stated. “As the Company has no further information to disclose regarding this pending legal matter, no investor call will be scheduled.”

Bottom Line…

The maker of Suboxone is being sued by 36 AGs for trying to block competition resulting in overpricing of the opioid addiction treatment medication.