PENNSYLVANIA RECORD

A newly filed antitrust suit alleges that Reckitt Benckiser Inc. has been engaging in an

overarching anticompetitive scheme to exclude competition from the market for the opioid blocker called Suboxone.

Attorneys representing Rochester Drug Co-Operative Inc. filed suit on behalf of the plaintiff and others similarly situated March 5 over claims that Reckitt Benckiser has employed various tactics as part of an overall scheme to improperly maintain and extend its monopoly power for co-formulated buprenorphine hydrochloride and naloxone hydrochloride dehydrate.

Under the brand name Suboxone, the drug is often used as opioid replacement therapy primarily to treat heroin addiction.

The co-formulated buprenorphine/naloxone drug combination is designed to curtail the effects of opioid withdraw.

The suit shows that when Suboxone was approved, the Food and Drug Administration gave Reckitt a seven-year period of regulatory exclusivity, during which the defendant marketed Suboxone tablets free from competition.

Once that seven-year period was up in October 2009, however, Reckitt knew that with the end of exclusivity would come less expensive generic versions of the drug.

The prospect of generic competition was alarming to Reckitt, the lawsuit states, because Suboxone formed a major portion of the defendant’s revenue and profits.

“Reckitt knew that generic competition posed a substantial threat to those profits,” the complaint reads. “Since generics are generally priced significantly below that of the brand-name drug, such products typically take the vast majority of the brand-name version’s sales directly and quickly after their introduction into the marketplace.”

In this case, the complaint alleges, Reckitt concocted a “multifaceted anticompetitive scheme, executed over the course of several years, to maintain and extend its monopoly power over co-formulated buprenorphine/naloxone, by illegally preventing generic manufacturers from effectively competing with Suboxone.”

The defendant’s scheme, the suit claims, was executed through a “purposeful and planned manipulation of the complex distribution and regulatory approval systems for pharmaceutical products in the United States.”

One of the steps in the scheme, the lawsuit states, was Reckitt’s development of a sublingual film version of Suboxone two years before the drug exclusivity was set to expire.

In deciding to market a new version of Suboxone, the suit says, the defendant intentionally decided to make its dosage form in the film different from the tablets, thereby preventing pharmacists from being able to legally substitute a less expensive generic version of the drug to patients.

“Disrupting this competitive mechanism was Reckitt’s entire reason for introducing Suboxone film: to the extent it could introduce its film version of Suboxone and cause the prescription base of branded Suboxone tablets to disappear, Reckitt would be able to hobble generic Suboxone tablet competition and prevent prices for co-formulated buprenorphine/naloxone from dropping to competitive levels,” the complaint states.

The defendant, however, had much difficulty in gaining FDA approval for the Suboxone film due to concerns about the product potentially being misused, abused or accessed by children.

The film, however was eventually approved by the FDA in the summer of 2010.

The plaintiffs claim that Reckitt’s motives for introducing the Suboxone film were predatory, and that the company was willing to sacrifice profits on Suboxone because the “sole purpose and effect of its costly plan to develop the film were not to provide a better or improved product, but simply to protect Reckitt’s Suboxone profits by thwarting, delaying and/or mitigating the impact of competition from generic Suboxone tablets by raising would-be generic competitors’ costs and excluding them from the most efficient means of distributing their generic Suboxone tablet products, via the automatic pharmacy substitution mechanism.”

The defendant is also accused of taking steps to destroy demand for Suboxone tablets and simultaneously coercing doctors to prescribe the Suboxone film, which did not face immediate generic competition.

Reckitt’s entire scheme, the lawsuit alleges, was done to harm competition.

The plaintiffs accuse the defendants of violating federal antitrust laws.

Aside from seeking class certification, the plaintiffs look to secure damages for the direct purchaser class, as well as the recovery of attorneys’ fees and costs.

The complaint was jointly filed by Philadelphia lawyers Eric L. Cramer and David F. Sorensen, of the firm Berger & Montague, attorneys Peter Kohn and Joseph T. Lukens, of the Jenkintown, Pa. firm Faruqi & Faruqi, and lawyers Barry S. Taus and Archana Tamoshunas, of the New York law firm of Taus, Cebulash & Landau.

The federal case number is 2:13-cv-01164-MSG.