Teva is set to be the first company to market a generic version of AstraZeneca’s blockbuster severe heartburn treatment Nexium in the US.
The FDA announced yesterday that it has approved Teva’s copy of Nexium, a delayed-release capsule containing esomeprazole magnesium to treat gastroesophageal reflux disease (GERD) in both adults and children.
The approval comes after a long battle to become to first company to market a generic version of Nexium, which has been one of AZ’s most successful products this millennium and had revenues of $2.8bn for the first nine months of 2014.
India-based Ranbaxy had been the initial forerunner to launch a cheaper version of the drug, but became embroiled in a legal battle where a court accused Ranbaxy and AZ had agreed to delay launch of the drug. It was later ruled this agreement was not anticompetitive.
However, the FDA revoked its approved for Ranbaxy’s version of Nexium after a year of problems with the company’s manufacturing operations in India that saw the agency prohibit several facilities from the production and distribution of drugs for the US market.
This delay provided AZ with a surprise windfall in its most prevent financial results.
Teva is now set to take advantage of what looks to be an exclusive market for generic Nexium and plans to launch in the “near future”. The drug will be marketed by Ivax Pharmaceuticals, a subsidiary of Teva.
Dr Kathleen Uhl, director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research, assured patients and doctors of the quality of the generic product in the wake of the problems at Ranbaxy.
“Healthcare professionals and consumers can be assured that these FDA-approved generic drugs have met our rigorous standards,” she said. “It is important for patients to have access to treatment options for chronic conditions.”
GERD is a serious form of gastroesophageal reflux, whereby a person’s stomach contents come back into the oesophagus. This can cause acid indigestion, more commonly known as heartburn.
Gastroesophageal reflux is definited as GERD when it occurs more than twice a week for a number of weeks.