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Generic Kalbitor

There are no generic Kalbitor (ecallantide) products available at this time. Kalbitor is a type of biologic medicine, which means it is made using live cells or organisms. Current regulations prevent companies from making generic versions of biologics. However, these laws are beginning to change, so a generic Kalbitor might become available at some point in the future.

Can I Buy Generic Kalbitor?

Kalbitor® (ecallantide) is a prescription medication approved for the treatment of sudden hereditary angioedema (HAE) attacks. Currently, a generic form of Kalbitor is not available.
Kalbitor is made by Jubilant HollisterStier, LLC, for Dyax Corp. It is considered a "biologic" medicine and is, therefore, under different laws and regulations than most other prescription medications.

What Is a Biologic?

A biologic product is a medication made using live cells or organisms. The live cells or organisms are used to make a complex mixture of proteins or molecules, which are then used to make medications or vaccines.
Vaccines, blood products, and gene therapies are examples of medical biologic products. Kalbitor is a biologic because it is a form of a human molecule.
Because these products are so complex, it can be difficult for a generic manufacturer to make an identical version of a biologic product. For this reason, generic biologics are sometimes called "biosimilars" or "follow-on biologics" instead of generics. Biosimilars or follow-on biologics are not considered identical to the currently approved brand-name product (as a generic product would be), but are similar enough to be safely substituted for it.

When Will a Generic Version Be Available?

It is difficult to predict when, or even if, a generic (or biosimilar) version of Kalbitor 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 near future.
Despite the changing regulations, it is unlikely that generic Kalbitor will be available any time soon. Kalbitor was approved in November 2009 and will, therefore, be protected from generic competition by patents for quite some time.

Kalbitor Medication Information

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