Exclusivity rights currently prevent generic Asclera from being manufactured in the United States. The earliest a generic version could be expected is March 2015, although certain factors could shorten or lengthen this exclusivity period. The active ingredient in Asclera, polidocanol, is sometimes referred to as the "generic name" -- however, this is not the same thing as a generic version.
Asclera is manufactured by Chemische Fabrik Kreussler & Co. GmbH for BioForm Medical, Inc. It is not available in generic form.
When Will Generic Asclera Become Available?
Chemische Fabrik Kreussler & Co. has the exclusive rights to sell Asclera in the United States until at least March 2015. Exclusivity rights are different from patents, although they provide similar protection against generic competition.
March 2015 is the earliest predictable date that a generic version of Asclera could become available. However, other circumstances could come up to extend or shorten the exclusivity period. This could include such things as lawsuits or patents for specific Asclera uses.
Is Polidocanol a Generic Asclera?
No -- polidocanol is the active ingredient in Asclera 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.
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 April 26, 2010.
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