Generic RotaTeq

Current laws and regulations prevent generic versions of RotaTeq from being manufactured. Medications that are made using live organisms are regulated under different laws than other medications; no generics are allowed to be made unless the generic manufacturer completes all the human studies necessary to approve a brand-new drug. If these laws change, however, generic versions of the vaccine may be available in the future.

RotaTeq Vaccine Information

Is a Generic Version of RotaTeq Available?

RotaTeq^® (rotavirus vaccine) is a vaccine given routinely to infants. It provides protection against rotavirus, a common cause of severe diarrhea in children.

RotaTeq is made by Merck & Co., Inc. Technically, RotaTeq is considered to be a "biologic" medication and is, therefore, under different rules and laws than most other medications. At this point, generic biologics (including generic RotaTeq) 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.

There is currently one other rotavirus vaccine on the market (Rotarix^®), but this is a different brand-name drug, not a generic version of RotaTeq.

Biologics and Generics

When the patents for regular drugs expire, generic companies can apply to make generic versions. These companies need to submit a little information proving that their product is the same as 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 very 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 has aimed at changing these laws. It is predicted that new laws and regulations will allow generic biologics in the near future.