Updated on 10 December 2012
Market exclusivity for AcipHex in the US will expire on November 8, 2013
Singapore: Japan-headquartered Eisai has gained an additional six months of US market exclusivity for AcipHex, which expires on November 8, 2013. Pediatric clinical data on proton-pump inhibitor AcipHex (rabeprazole sodium) submitted to the US Food and Drug Administration (FDA) by US subsidiary of Eisai has met the FDA's written request requirements for pediatric exclusivity.
AcipHex, which is sold as Pariet in Japan, is classified as a proton-pump inhibitor that effectively suppresses gastric acid secretion while inhibiting enzyme activity during the last phase of stomach acid secretion. It was launched in the US in 1999, following its launch in Japan in 1997 and in Europe in 1998. It is currently approved in more than 90 countries worldwide.
In the US, the drug is currently approved for the healing and maintenance of healing of erosive and ulcerative GERD, treatment of symptomatic GERD, healing of duodenal ulcers, and Helicobacter pylori eradication to reduce the risk of duodenal ulcer recurrence.
The drug is also indicated in the US for adolescent patients ages 12 and older for the short-term treatment of symptomatic GERD. Furthermore, an additional indication has been submitted to the FDA for the healing and maintenance of healing of GERD and symptom improvement of GERD in children ages 1 year to 11 years.