Teva wins big as FDA approves its generic Nexium
- Generic esomeprazole, used to reduce stomach acid and treat gastroesophageal reflux disease (GERD), was approved by the FDA on Monday. It is the first FDA-approved generic of AstraZeneca's flagship heartburn drug Nexium.
- Generic esomeprazole, a proton pump inhibitor, is manufactured by Ivax, a subsidiary of Teva Pharmaceuticals, and is available in 20 and 40 milligram capsules.
- In addition to being used to treat GERD, generic esomeprazole is also used to reduce the risk of gastric ulcers associated with use of non-steroidal anti-inflammatory drugs (NSAIDs).
Gastroesophageal reflux (GER) occurs when food comes from the stomach back into the esophagus, resulting in acid indigestion; however, GERD is more serious and chronic. Technically, GERD is GER that happens more than twice a week for a few weeks. People with this condition are ideal candidates for esomeprazole, which when used over a long period of time at very high doses can lead to stomach problems and an increased risk of bone fractures.
But patients aren't the only ones who have a reason to smile. Teva is going to make a killing off of this approval—one which didn't come easily, either. The FDA originally approved a generic Nexium from India-based Ranbaxy Labs before yanking the approval over manufacturing practice concerns. There's also been plenty of litigation involving Teva, AZ, Dr. Reddy's Labs, Endo, and Ranbaxy centering on pay-to-delay arrangements and other potential generic Nexium launches.