Because Synagis (palivizumab) is a type of "biologic" medicine and is regulated under different laws than most other prescription medications, companies are not allowed to make a generic version. However, these laws are starting to change, which could make it possible to have generic versions of biologic products. Until this happens, it is difficult to predict when generic Synagis might be made.
Can I Buy Generic Synagis?Synagis® (palivizumab) is a prescription medication used in infants and children who are at high risk for serious respiratory tract problems from respiratory syncytial virus (RSV), which infects the lungs and airways. The medication is given as a monthly shot during the time that RSV infections are most common.
Synagis is manufactured by MedImmune, LLC. At this time, it is not available in generic form.
When Will a Generic Version Be Available?This question is difficult to answer for several reasons. Synagis is a monoclonal antibody, and like other monoclonal antibodies, is considered a "biologic" medication. In general, biologics are medical products made using live cells or organisms. The living cells or organisms are used to create complex proteins or molecules that can then be used to treat or prevent medical conditions. Examples of biologics include vaccines, blood products, and gene therapies.
While other prescription medicines have known and reproducible chemical structures, most biologics are not so easily characterized. Instead, biologics are complex proteins or molecules that are not easily reproduced. This can make it difficult for generic manufacturers to make identical versions of biologic products already on the market.
Because of these issues, previous regulations did not allow generic versions of biologic products to be manufactured. However, the regulations are changing to allow generic manufacturers to make products that are similar enough to brand-name biologics to be considered interchangeable. The terms "biosimilars" or "follow-on biologics" are sometimes used to describe these similar, yet not identical, generic versions.
However, even with the changing regulations, it is not clear when a generic version of Synagis may be available. There is still much rulemaking to be done before any generic biologic is on the market. When the path is clear for generic biologics, a company will need to decide to make a generic version of Synagis in order for it to be available.
Furthermore, Synagis may still be protected from generic competition by patents for several years. It was approved by the U.S. Food and Drug Administration (FDA) in June 1998. It is not exactly clear when the patents for the drug expire, as the FDA does not yet list applicable patents for biologics, as it does for other medications.