FDA has approved the first generic version of Nexium—esomeprazole magnesium delayed-release capsules—to treat gastroesophageal reflux disease (GERD) in adults and children aged 1 year and older. Esomeprazole is a proton pump inhibitor (PPI) that reduces the amount of acid in the stomach.
Ivax Pharmaceuticals, Inc, a subsidiary of Israeli-based Teva Pharmaceuticals, has gained approval to market esomeprazole in 20-mg and 40-mg capsules.
The drug already has an OTC version, Nexium 24Hr, which is 22.4mg of esomeprazole, roughly the equivalent of the 20mg Rx only version.
Ranbaxy, which had its 180 day exclusivity of a generic Nexium revoked by the FDA earlier in the week, continued to have its effort for a generic Nexium frustrated by the FDA blocking its importation of the raw ingredient from its manufacturing plants in India. The latter have been subject to shut down by the FDA due to multiple alleged violations of Good Manufacturing Processes (GMPs).
Patients using brand name Nexium, the Rx only version, should consult with their pharmacist or doctor on how and when they can begin receiving the Ivax generic formulation, along with the lower cost and copay that goes with generic drugs at retail pharmacy Rx plans.