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Generic Menactra
Menactra (meningococcal vaccine) is only available as a brand-name drug. Generic versions are not allowed because Menactra is a "biologic" medication that is currently under laws that prevent generic biologics from being made. However, these rules are likely to change in the near future, allowing companies to manufacture generic Menactra.
Menactra® (meningococcal vaccine) is one of a few available meningococcal vaccines. It is approved for use in people age 9 months through 55 years old. It is given as a single dose and provides protection against invasive meningococcal diseases, such as bacterial meningitis.
Menactra is made by Sanofi Pasteur, Inc. No generic versions of Menactra are available at this time. Two other meningococcal vaccines are available (Menomune®, also made by Sanofi Pasteur, and Menveo®, made by Novartis); however, these are not interchangeable with Menactra.
Technically, Menactra is considered a "biologic" medication and is, therefore, under different rules and laws than most other medications. At this point, generic biologics, including generic Menactra, are not allowed to be made. However, the laws are changing, and it is likely that generic biologics will be permitted in the near future.
Understanding Biologics and Generics
When the patents for regular drugs expire, other manufacturers can apply to make generic versions. These companies need to submit a little information proving that their product is equivalent to the brand-name drug, but they do not have to repeat all of the human studies to show the drug to be safe and effective.
Human studies are expensive and time-consuming, and generic medications are less expensive because they do not need all the human studies.
However, biologics (medications made using live cells or organisms, also known as "biopharmaceuticals") are regulated under a different set of laws. Under these laws, there is no way for a generic biologic to be approved, unless the generic manufacturer completes all of the human studies necessary to approve a brand-new drug.
Because such studies are extremely expensive, it is likely that a generic biologic would not be any less expensive than the brand-name product. Essentially, if a generic biologic were to be approved, it would not really be a generic, but a new and separate drug that would not be equivalent to the brand-name product.
However, recent legislation is aimed at changing these laws. It is predicted that new laws and regulations will allow generic biologics in the near future.
Written by/reviewed by: Kristi Monson, PharmD; Arthur Schoenstadt, MD
Last reviewed by: Kristi Monson, PharmD