BRUSSELS (AP) — European Union regulators said Thursday that they suspect Danish drug maker Lundbeck may have delayed the launch of a cheaper, generic version of its antidepressant drug in Europe.
The European Commission said it had opened a formal antitrust investigation to check whether H. Lundbeck A/S made deals with other pharmaceutical companies to delay them selling citalopram after Lundbeck’s exclusive right to the drug it developed ran out in 2003.
Citalopram is one of the most widely used drugs to treat depression and anxiety and is sold under the name Celexa in the U.S. and Canada and Cipramil in most of Europe. It acts by altering serotonin levels which can raise a person’s mood.
Lundbeck said it was fully cooperating with regulators and was “confident that the group has complied with all relevant national and EU competition legislation.”
The company recently patented escitalopram, which is chemically similar to citalopram. Three generics companies tried to challenge that patent in the British courts, claiming it was not significantly different to the original drug. In 2008, Lundbeck won on appeal, protecting its patent.
EU regulators said they would investigate allegations about Lundbeck’s behavior and agreements “as a matter of priority.” There is no deadline for wrapping up the case.
EU spokesman Jonathan Todd said delays in the rollout of generic drugs had “major implications for patients and for national health budgets because obviously generic drugs are often very substantially cheaper than originator drugs.”
The EU’s competition commissioner Neelie Kroes warned in July that major drug makers face a wave of antitrust investigations after regulators concluded a broad inquiry into the pharmaceutical sector that said drugs companies are deliberately stalling cheaper generic versions of their own medicines once exclusive patents expire.
The EU says generic drugs are on average 40 percent cheaper than their branded rivals two years after they launch. It warned that it knew of at least 200 settlement agreements — some including payments to delay drug launches — between generic and brand-name drug makers that could restrict the rollout of generic versions.
Associated Press writer Jan M. Olsen in Copenhagen contributed to this story.