Opana ER Consumers Overpaying For Prescription, “Pay For Delay” Scheme

We are currently investigating potential antitrust and consumer protection claims against the manufacturer of Opana ER (Extended Release). Opana ER is a widely-prescribed narcotic analgesic (oxymorphone hydrochloride). Opana ER comes in 5, 7.5, 10, 15, 20, 30 and 40 mg dosage strengths. Opana ER is manufactured and sold by Endo Pharmaceuticals.

We are investigating whether Endo engaged in sham patent litigation against potential generic competitors to exclude generic competition from the market. By filing meritless patent lawsuits against generic drug makers, Endo maintains its monopoly in the Opana ER market. This anticompetitive behavior may result in consumers being forced to pay much higher prices for Opana ER.

opanaWhen generic versions of brand-name drugs are introduced into the market, the price of both the generic and the brand-name version decrease dramatically. To prevent generic competition, brand name drug manufacturers routinely file patent infringement suits against generic manufacturers once the generic manufacturers files an ANDA, or abbreviated New Drug Application, with the FDA seeking permission to develop a generic drug version.

By filing a meritless patent lawsuit, brand-name drug manufacturers are automatically granted an additional 30-month exclusivity period for the drug. As this 30-month exclusivity period is set to expire, the brand-name manufacturer will frequently enter into a settlement agreement with the prospective generic competitor.

In these sham settlements, the generic drug manufacturer agrees to forego generic production, and in return the generic manufacturer receives illicit payoffs from the brand-name company.

These so-called “pay-for-delay” agreements are under strict scrutiny from the Federal Trade Commission for their potential anticompetitive effect of blocking cheaper generics from reaching the public.