It is difficult to predict when, or even if, a generic version of Elitek will be available. Previously, regulations did not allow generic manufacturers to make generic versions of biologics. However, regulations are currently changing to allow a pathway for generic versions in the very near future.
Despite the changing regulations, it is unlikely that generic Elitek will be available any time soon. Elitek was approved in July 2002, and is protected from generic competition by a patent that expires in July 2016.
Is Rasburicase a Generic Elitek?
No -- rasburicase is the active ingredient in Elitek, not a generic version of it. What can be confusing is that the active ingredient of a drug is often 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, the original medicine must have gone off-patent, and another company besides the original manufacturer must make the product.
Food and Drug Administration Web site. Vaccines, Blood and Biologics, Resources for Healthcare Providers. Available at: http://www.fda.gov/BiologicsBloodVaccines/ResourcesforYou/HealthcareProviders/default.htm. Access October 21, 2012.
The United States Patent and Trademark Office (USPTO). Patent term extensions. USPTO Web site. Available at: http://www.uspto.gov/patents/resources/terms/156.jsp. Accessed October 21, 2012.
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