FTC files lawsuit against Endo for allegedly paying generic pharmas to delay release of generic pain relief drug

The US Federal Trade Commission (FTC) accused pharmaceutical company Endo of paying generic drug manufacturer to delay the release of generic drugs. The FTC filed on Thursday a lawsuit against Endo which manufactures Lidoderm and Opana ED, branded pain relief medication.

The patents of the two drugs, held by Endo, expired in 2010, but the Pennsylvania-based drugmaker allegedly paid to generic medicine manufacturers millions of dollars to delay the release of cheaper versions of the two painkillers until 2013. The two drug accounted for 64 percent of Endo’s revenue in 2009, contributing about $1 billion (AUD$1.3 billion), reports Gizmodo.

Lidoderm is the first proprietary, patented product of Endo which the company that has global headquarters in Dublin, Ireland, launched upon receiving US Food and Drug Administration approval. It licensed Lidoderm from Hind Healthcare.

Had not Endo allegedly blocked the sale of generic equivalents of the two painkillers, it would have cost patients a lot less. The FTC estimates generic drugs in the US cost about 75 percent less compared to branded medicine. Using generics save the US healthcare system about $254 billion (AUD$331.7 billion) yearly.

In its complaint, the FTC says, “Endo knew that generic competition would decimate its sales of the corresponding branded products and that any delay in generic competition would be highly profitable for Endo, but very costly for consumers.”

Endo, in a statement, says it is disappointed with FTC’s lawsuit but insists it did not do anything illegal. The company stresses that the settlements it made complied with applicable law, hence, the FTC case, which it would vigorously defend, lacks merit.

Pay-for-delay accusations have been made in the past against the makers of branded drugs such as Lipitor, Effexor, Wellbutrin and Adderall. The pharmaceutical firms allegedly delayed the release of generic equivalents of these brands up to nine years.

Endo’s co-defendants in the FTC lawsuit, according to the complaint the commission filed with the US District Court for the Eastern District of Pennsylvania, are Endo International, Teikoku Pharma in California, Teikoku Seiyaku in Japan, Watson Laboratory in New Jersey, Allergan in Dublin and Impax Laboratories in California.

Endo allegedly convinced Impax in 2010 to abandon the patent challenge to its generic version of Opana, an opioid drug. Together with partner Teikoku, Endo also convinced Watson to abandon the patent challenge to Lidoderm, a lidocaine patch, in May 2012.