Due to the severe shortage of Doxil (liposomal doxorubicin), you can now buy a foreign version of the medication in the United States, at least temporarily. The product's patents expired in 2009 -- however, a true generic version probably will not become available until at least 2014, when this medication will no longer be protected by "orphan drug exclusivity."
Doxil is manufactured by Ben Venue Laboratories, Inc., for Ortho Biotech Products. At this time, no generic versions of Doxil are available. However, due to a shortage of Doxil, the U.S. Food and Drug Administration (FDA) has temporarily allowed the importation and use of Lipodox™, a foreign version of Doxil, to help alleviate the severe shortage.
When Will Generic Doxil Be Available?
Although the patents for Doxil expired in October 2009, Doxil is likely to be protected against generic competition until May 2014, due to "orphan drug exclusivity," which is an extended period of protection used as a way of rewarding companies who research and produce drugs that are used for rare conditions.
Is Doxorubicin the Same as Generic Doxil?
No -- doxorubicin is the active ingredient in Doxil, but is not a generic version of it. What can be confusing is that oftentimes, the active ingredient of any 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.
Nonliposomal doxorubicin (Adriamycin®) is available in generic form, but is not equivalent to Doxil.
Written by/reviewed by: Kristi Monson, PharmD;Arthur Schoenstadt, MD
Lipodox [package insert]. Halol, Gujarat: Sun Pharmaceutical Industries Limited;2012 January.
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 March 11, 2010.
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