Md. Joins Suit Against Recovery-Drug Maker as Opioid Overdoses Rise



ANNAPOLIS (Sept. 23, 2016)—Attorney General Brian E. Frosh joined 35 other attorneys general in filing a multi-jurisdictional lawsuit Thursday accusing the makers of Suboxone, an opioid addiction treatment, of conspiracy to monopolize and illegal restraint of trade.

British pharmaceutical company Indivior, which manufactures the drug, allegedly kept generic versions of the drug from competing with its tablet form, causing consumers and purchasers to pay "artificially high monopoly prices since late 2009," according to a statement from Frosh's office.

The opioid epidemic continues to swell, taking an average of 78 American lives each day, according to the U.S. Department of Health and Human Services, and increasing steadily from year to year in Maryland (bha.dhmh.maryland.gov/OVERDOSE_PREVENTION/SiteAssets/Pages/Data-and-Reports/Quarterly%20report_2nd%20quarter%202016%20(1).pdf).

Between January and June of this year, 920 people died of opioid overdoses in Maryland, a significant increase from the 601 overdose-related deaths that occurred in the same time frame last year, according to the state's Department of Health and Mental Hygiene.

Suboxone occupies opioid receptors, helping to reduce cravings and keep recovering users from suffering withdrawal symptoms.

"The defendants in this case have preyed on a vulnerable population—men and women trying (to) overcome the scourge of opioid addiction," said Frosh in the statement. "Free and fair competition is necessary to keep drug prices affordable and to keep much-needed prescription drugs accessible to those who rely on them for treatment."

Meanwhile, Indivior saw more than $1 billion in net revenue in 2015, and Suboxone maintained an average of 59 percent of the market share in the U.S. in 2015, according to the company's annual report.

Indivior, then called Reckitt Benckiser Pharmaceuticals, originally released Suboxone in the form of tablets in 2002, and secured a seven-year period of exclusivity protection, meaning no generic alternative could enter the market during that time.

The company continued to develop the film form of Suboxone, which was approved by the FDA in August 2010. The film resembles breath-mint strips, while generic alternative tablets were not on the market.

Through a series of unfounded safety concerns to the Food and Drug Administration, the attorneys general alleged in their lawsuit, the pharmaceutical company interfered in the sale of generic versions of Suboxone tablets until it eventually removed the tablet from the market completely, leaving consumers virtually no choice but to use the company's film.

"The alleged scheme the defendants utilized denied consumers the choice of a generic version of Suboxone," Pennsylvania Attorney General Bruce Beemer said. "This conduct forced consumers to pay more for Suboxone and severely limited their options for treating their opioid addictions."

Indivior received notice of the suit, which is being brought by 35 states and the District of Columbia, and released a statement acknowledging the allegations Friday.

"The Company intends to continue to vigorously defend its position," Indivior wrote.

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