A brand, a generic, an OTC: Nexium (esomeprazole) will take many forms soon

April 30, 2014
Pharmaceutical Commerce, Pharmaceutical Commerce - May/June 2014,

AstraZeneca plots next moves

As the end of AstraZeneca’s patent on Nexium approaches, the company is looking at how to maintain branded sales in the face of generic competition. One action, announced in early March, is a “Nexium Direct” program, which allows patients (with a valid prescription) to order product directly, and receive a cost-saving coupon as well.

Meanwhile, Pfizer, to whom AstraZeneca sold the rights to sell an OTC version of the drug, announced it late March that it had received FDA approval to market its version (a 20mg tablet equivalent to Nexium® 24HR) in the US, and is also seeking approval for the brand-to-OTC conversion in Europe.

The generic version will come sooner or later, but for the time being is tied up in Ranbaxy’s difficulties in manufacturing approvable products in several of its Indian facilities. FDA had imposed restrictions on products from those facilities entering the United States—which has affected both esomeprazole production as well as those of other products. Daiichi Sankyo, the Japanese pharma company that acquired Ranbaxy several years ago for $6.4 billion, has just unloaded the company to Sun Pharma, a Mumbai-based generics manufacturer. Resolving the FDA ban on Ranbaxy production will take time, although there were press reports that Ranbaxy had been looking for alternative supplies of the active ingredient as a stopgap measure.