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Generic Amitiza

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 May 2011, when the first patent for Amitiza expires. However, lawsuits or other patents for specific uses may extend or shorten the availability of generic Amitiza.

Generic Amitiza: An Overview

Amitiza® (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.
     
Brand-name Amitiza is made by Sucampo Pharmaceuticals, Inc. and Takeda Pharmaceuticals America, Inc. It is currently under the protection of a patent that prevents any generic Amitiza from being sold in the United States.
 

When Will Generic Amitiza Be Available?

The first patent for Amitiza currently expires in May 2011. This is the earliest predictable date that a generic version of the drug could become available. 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.
 
Written by/reviewed by: Kristi Monson, PharmD; Arthur Schoenstadt, MD
Last reviewed by: Kristi Monson, PharmD;
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