Because Embeda (morphine sulfate/naltrexone hydrochloride) is protected by an unexpired patent, no generic versions are available at this time. The exclusivity rights expire in June 2027, which is likely the earliest predictable date that a generic Embeda may be manufactured. However, if you cannot afford Embeda and you are not at risk of abusing morphine by snorting or injecting it, there may be more affordable pain medications.
Embeda is made by Actavis Elizabeth LLC for King Pharmaceuticals, Inc. It is currently under the protection of a patent that prevents any generic Embeda from being manufactured in the United States.
When Will Generic Embeda Be Available?
The patent for Embeda is set to expire in June 2027. Therefore, June 2027 is the earliest predictable date that a generic version of Embeda could become available.
However, there are other circumstances that could extend or shorten the exclusivity period of Embeda. This could include such things as lawsuits or other patents for specific Embeda uses. Once Embeda goes off patent, there may be several companies that manufacture a generic Embeda drug.
Are There Less Expensive Alternatives?
If your healthcare provider does not feel you are at risk for abusing morphine by snorting or injecting it, there may be suitable, morphine-only products (without the naltrexone) that are not as expensive. Because the naltrexone has no effect when Embeda is taken properly, a long-acting morphine product ("morphine ER") may be a good option. If you cannot afford Embeda, check with your healthcare provider about more affordable options.
Written by/reviewed by: Kristi Monson, PharmD;Arthur Schoenstadt, MD
Last reviewed by: KristiMonson, PharmD;
List of references (click here):
Embeda [package insert]. Bristol, TN: King Pharmaceuticals, Inc.;2009 June.
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 April 10, 2012.
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