At this time, no generic Amitiza (lubiprostone) products are approved in the United States. The earliest that a generic version of the drug could become available is July 2014, when the current patent for Amitiza expires. However, lawsuits or other patents for specific uses may extend or shorten the availability of generic Amitiza.
Generic Amitiza: An OverviewAmitiza® (lubiprostone) is a prescription medication approved for the following conditions:
- Long-term constipation with no known cause (chronic idiopathic constipation) in women and men
- Irritable bowel syndrome (IBS) with constipation in women
- Constipation due to opioid pain medications in people with chronic noncancer pain.
Brand-name Amitiza is made by Sucampo Pharmaceuticals, Inc. and Takeda Pharmaceuticals America, Inc. At this time, there are no generic versions of Amitiza.
When Will Generic Amitiza Be Available?
The first patent for Amitiza expired in May 2011, yet no generic versions are available. The next Amitiza patent will expire in July 2014. This is the earliest predictable date that a generic version of the drug could become available.
Also, the patents for the latest approved use of the drug (opioid constipation) do not expire until November 2022, and it is possible (but not certain) that these patents may provide protection against generic competition.
However, other circumstances could come up to extend or shorten the exclusivity period. This could include such things as lawsuits or other patents for specific Amitiza uses. Once the patent expires, several companies will likely begin manufacturing a generic Amitiza drug.
Is Lubiprostone the Same as Generic Amitiza?No -- lubiprostone is the active ingredient in Amitiza, but is not a generic version of it. This can be confusing, as the active ingredient of a drug is referred to as the "generic name." The generic name is different from a generic version of a medicine. In order for there to be a generic version of a medicine, the original medicine must have gone off-patent and another company besides the original manufacturer must make the product.