Endo Health Solutions ($ENDP) tried hard to ward off generic competitors for its big-selling pain med Opana ER. For instance, it petitioned the FDA to block competitors on safety grounds. According to a new lawsuit, Endo also paid off generics maker--and potential rival--Impax Laboratories ($IPXL).
In a suit filed Friday, a Farmingdale, NY-based construction workers' health and welfare fund accused the Dublin-based company of forking over more than $112 million to keep its copy off the market between June 2010 and January 2013, Bloomberg reports.
Over that time, Endo worked to switch patients to a new, opioid-abuse resistant formulation to preserve sales, the International Union of Operating Engineers, Local 138 Welfare Fund said in the complaint. "Endo literally bought itself freedom from generic competition," it wrote, as quoted by the news service.
It's just the latest set of similar pay-for-delay allegations for Endo. In June, Rochester Drug Cooperative sued the company, claiming that Endo paid $112 million to settle a patent fight with Impax. The generics maker agreed to delay its version of the painkiller in return for cash payments, the suit claimed.
Whether Endo did pay Impax in one of pharma's controversial pay-for-delay schemes, things didn't quite work out the way it hoped with Opana, a drug that generated 10% of the Malvern, PA-based company's revenue in 2012. Facing plunging share prices, shareholder agitation and the upcoming patent expiration of top-selling Lidoderm, Endo petitioned the FDA to declare the original version of the med--and its knockoffs--unsafe and strike them from the market.
But the FDA didn't buy it, refusing to hold up generics and to grant Endo new language that dubbed Opana abuse-deterrent. "We think the public health would not be served if a company can market itself as 'abuse deterrent,' if the scientific evidence did not support that claim," a CDER director said last May.
Now, the class-action case could further the drugmaker's Opana woes at a time when regulators have been coming down hard on pay-for-delayers. The welfare fund seeks unspecified monetary damages, which would triple under federal antitrust laws, Bloomberg reports.
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