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Shares in Indivior PLC (LON:INDV) nosedived on Friday after it emerged that 35 US states and the District of Columbia have joined a class action against the UK pharma. The UK pharma company, which was spun off from Reckitt Benckiser at the end of 2014, is the maker of Suboxone, one of the best-selling treatments for opioid addiction. Indivior has said that it will “vigorously defend its position” against the claims. The company’s share price has added over 75% in the last six months, even accounting for today’s slump, after a strong swell of positive news flow. Back in June the company won a ruling at a federal court in Delaware that meant generic versions of Suboxone won’t be allowed to hit the US market until 2024. In August, the company also announced “positive top-line results” from the Phase III trial of its investigational new anti-addiction drug treatment RBP-600. The drug accounts for around four-fifths of the company’s revenue currently, and reportedly achieved blockbuster status (more than US$1bn of sales) back in 2011. A tablet version of Suboxone was given the green light for sale in the US back in 2002 although it didn’t have patent protection. Instead, the US Food and Drug Administration (FDA) gave it “orphan drug” status which meant Indivior effectively had a seven year monopoly on the drug. That way, the company could recoup most of the costs associated with developing a drug that the US government deemed to be useful. A win-win situation, some might say. This is where the lawsuit comes in, though. It alleges that when the orphan status monopoly was close to expiring, Indivior took steps to block cheaper, generic versions from hitting the marketplace through “a range of anticompetitive conduct”. Another company, MonoSol Rx Inc, is also being sued after allegedly helping Indivior to try and extend its monopoly. The suit claims that MonoSol licensed its ‘sublingual film’ technology to the British firm, which meant Indivior could switch Suboxone from a tablet to dissolvable strip form. By doing this, the lawsuit argues that Indivior tried to trick the FDA into thinking that the drug had changed sufficiently and that any generic version of the pill should be rendered invalid. If the strip was not seen to be equivalent to the pill form of Suboxone, pharmacists wouldn’t be able to prescribe the cheaper generic pills to patients. The lawsuit adds that London-listed Indivior raised safety concerns about the tablet form of the drug in an attempt convince the FDA to approve the strip form while at the same time invalidating the new generic pills. The FDA rejected the firm’s arguments, but by the time generic tablets hit the marketplace, many patients had already switched to the dissolvable film form, for which there is no generic alternative, the suit claimed. Shares in Invidior were down 11% to 292p.
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A generic drug (generic drugs, short: generics) is a drug defined as "a drug product that is comparable to brand/reference listed drug product in dosage form, strength, route of administration, quality and performance characteristics, and intended u...