At this time, brand-name Aciphex is under the protection of a patent, so there is currently no generic Aciphex available. The earliest that a generic version could be produced is November 2013, when the patent expires. However, the drug's exclusivity period could be shortened or extended due to lawsuits or other factors.
Aciphex® (rabeprazole sodium) is a medication that has been licensed to treat a number of conditions, including:
- Gastroesophageal reflux disease (GERD)
- Erosive esophagitis
- Helicobacter pylori (H. pylori) infections
- Pathological hypersecretory conditions (such as Zollinger-Ellison syndrome).
- Duodenal ulcers.
Aciphex is made by Eisai Co., Ltd. It is marketed by Eisai and PRICARA, a division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. It is currently under the protection of a patent that prevents any generic Aciphex from being manufactured in the United States.
When Will Generic Aciphex Be Available?
Aciphex is protected by a patent that is currently set to expire in November 2013. It was initially set to expire six months earlier, but was extended in exchange for the manufacturer performing much-needed pediatric studies. This is the earliest predictable date that a generic version of Aciphex could become available.
However, there are other circumstances that could come up to extend or shorten the exclusivity period of Aciphex. This could include such things as lawsuits or other patents for specific Aciphex uses. Once Aciphex goes off patent, there may be several companies that manufacture a generic Aciphex drug.
The November 2013 patent for Aciphex has already been legally challenged, and the court's decision upheld the patent (meaning that no generic versions would be allowed earlier than November 2013). It is possible (but unlikely) that the patent could be challenged again.