States sue makers of Suboxone on antitrust charges

Thirty-six attorneys general nationwide have filed an antitrust suit against the makers of Suboxone, a prescription drug used to treat opioid addiction.

The suit, filed Sept. 22, alleges companies engaged in a scheme to block generic competitors from producing the drug and force purchasers to pay artificially high prices.

Reckitt Benckiser Pharmaceuticals, now known as Indivior, is accused of conspiring with MonoSol Rx to switch Suboxone from a tablet version to a film that dissolves in the mouth to prevent or delay other companies from developing generic alternatives, states a press release from Attorney General Matt Denn.

According to the suit, the conspiracy allowed the companies to maintain monopoly profits. The companies are accused of violating state and federal antitrust laws.

Denn said statistics show Delaware had the ninth-highest drug-overdose rate in the country in 2013. "Medically assisted treatment of substance use disorder is an important part of addressing this problem, and the cost of such treatment is one of the barriers to providing it," Denn said in the press release.

Noting Delaware is concerned about any violation of antitrust laws, Denn said, "Our concern is heightened when the result is artificially heightened prices for a drug used to help address this critical problem in our state."

The suit alleges when Reckitt introduced Suboxone in 2002 in tablet form, it had exclusivity protection for seven years, meaning no generic version could enter the market during that time.

Before that period ended, however, Reckitt worked with MonoSol to create a new version of Suboxone – a dissolvable film, similar in size to a breath strip. Over time, Reckitt allegedly converted the market away from the tablet to the film through marketing, price adjustments, and other methods. Ultimately, after the majority of Suboxone prescriptions were written for the film, Reckitt removed the tablet from the U.S. Market.

The attorneys general allege this conduct was illegal product hopping, where a company makes minor changes to its product to extend patent protections so other companies can't offer cheaper generic alternatives.

According to the suit, the Suboxone film provided no real benefit over the tablet, and Reckitt continued to sell tablets in other countries even after taking them off the U.S. market. Reckitt also allegedly expressed unfounded safety concerns about the tablet version and intentionally delayed FDA approval of generic versions of Suboxone.

As a result, the attorneys general allege that consumers and 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.

The lawsuit, filed in the U.S. District Court for the Eastern Division of Pennsylvania, accuses the companies of violating the federal Sherman Act and state antitrust laws. 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.