No generic versions of Exalgo (hydromorphone ER) are available at this time. It's unclear why this is the case, as a generic version was expected to be introduced in November 2013. It's important to note that hydromorphone ER is the "generic name" for this product; it's not a "generic version."
Can I Buy Generic Exalgo?
Exalgo™ (hydromorphone ER) is a prescription pain medication. It comes in extended-release tablets that release hydromorphone slowly throughout the day. It is typically taken just once daily.
Exalgo is made by Mallinckrodt Brand Pharmaceuticals, Inc. At this time, no generic versions of Exalgo are available.
When Will Generic Exalgo Be Available?
The first patent for Exalgo currently expires in July 2014. Normally, this would be the earliest predictable date that a generic version could become available. However, as the result of the settlement of a lawsuit between drug manufacturers, a generic version was expected to become available in November 2013. No generic versions are available yet, and it is unclear what, exactly, happened with that deal or when to expect one.
In addition, other circumstances could extend or shorten the exclusivity period. This could include such things as lawsuits or other patents for specific Exalgo uses. Once the patent expires, several companies will likely begin manufacturing a generic Exalgo drug.
Is Hydromorphone a Generic Exalgo?
No -- hydromorphone is the active ingredient in Exalgo, but is not a generic version of it. Generic versions of immediate-release hydromorphone are available, but these medications are not equivalent to Exalgo.
What can be confusing is that oftentimes, 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
Food and Drug Administration, Center for Drug Evaluation and Research. Electronic orange book: approved drug products with therapeutic equivalence evaluations. FDA Web site. Available at: http://www.fda.gov/cder/ob/. Accessed December 3, 2013.
Drug Store News. Watson, Mallinckrodt settle over generic painkiller (9/5/2007). DSN Web site. Available at: http://drugstorenews.com/article/watson-mallinckrodt-settle-over-generic-painkiller. Accessed February 22, 2012.
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