Does Nexium Have a New Competitor in Esomeprazole Strontium?

In 2012, Nexium sales in the US reached $6 billion, making it one of the top five best-selling prescription drugs.

Used to treat acid reflux and gastroesophageal reflux disease (GERD), Nexium is a proton pump inhibitor (PPI). These drugs inhibit gastric acid production, and have superseded another class of drugs known as H2-receptor antagonists in popularity as treatment for acid reflux and GERD. A PPI works by irreversibly blocking the proton pump stage of gastric acid secretion, and can reduce secretion of gastric acid by up to 99%. This reduction in stomach acid helps in healing of duodenal ulcers and reduces pain from acid reflux. A new PPI called esomeprazole strontium, manufactured by a South Korean pharmaceutical company called Hanmi Pharmaceutical, recently won approval by the Food and Drug Administration (FDA) for sale in the US.

What Is Esomeprazole Strontium?

Esomeprazole strontium is the active ingredient in the new drug, and it works very similarly to how Nexium works, blocking the final step in gastric acid production, reducing problems associated with acid reflux and GERD. The effect is dose-related, up to daily doses of 20 to 40 mg. Hanmi’s product, if sold in the US, would mark the first time a non-innovator pharmaceutical product containing esomeprazole made it into the US market. Additionally, Hanmi would be the first Korean company to make it to the US market under what is known as the Hatch-Waxman exception, which allows generic pharmaceutical manufacturers to prepare generics even before a US patent has expired.

How Is It Like Nexium?

Esomeprazole strontium is very similar to Nexium, since it is a proton pump inhibitor and is used to treat GERD, acid reflux, and duodenal ulcers, as well as rarer conditions that cause excessive gastric acid to be produced. It is a delayed-release capsule that is taken like Nexium for periods of up to 14 days.

How Is It Different from Nexium?

Nexium’s active ingredient is esomeprazole magnesium in a delayed release capsule. Comparative bioequivalence testing was done by Hanmi to show that esomeprazole strontium works very similarly to Nexium. Strontium is an alkaline earth metal with chemical properties similar to those of calcium and barium. Magnesium, part of Nexium’s active ingredient, is also an alkaline earth metal and is found in the human body where it is essential to living cells. Magnesium is also commonly used in antacids and laxative medications.

Though esomeprazole strontium received FDA clearance, litigation between Hamni and AstraZenica, manufacturer of Nexium, may keep it off US pharmacy shelves for the time being. Patent litigation recently ended with the courts saying that AstraZenica’s patents are valid, but that esomeprazole strontium does not violate those patents. AstraZenica is seeking reversal on appeal to the US Court of Appeals for the Federal Circuit. Hanmi may choose to hold an “at-risk” launch of its product, but should AstraZenica win its appeal, Hanmi would then be subject to double penalties under the law.

Currently, Nexium is available in the US, but esomeprazole strontium is not. American patients who take Nexium for acid reflux or GERD will have to continue with it while the litigation between Hanmi and AstraZenica plays out in the Federal Court of Appeals.

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