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Because Caphosol is a "medical device," rather than a prescription medication, no generic mouth rinses are considered equivalent to the brand-name product. This is because medical devices do not receive equivalence ratings from the Food and Drug Administration. Therefore, no tests are done to determine whether a generic Caphosol exists or if a generic product would have the same effects as the brand-name product.
Can I Buy Generic Caphosol?Caphosol® (supersaturated calcium phosphate rinse) is a prescription mouth rinse that belongs to a group of medicines known as saliva substitutes. It is used to relieve dry mouth in people with reduced saliva from a variety of causes. It is also used to treat mucositis (mouth sores) caused by certain cancer treatments.
Caphosol is made by Catalent Pharma Solutions, LLC, for EUSA (USA) Pharma, Inc. It is considered a medical device. Unlike prescription medications, medical devices do not have generic equivalents. Therefore, there is no generic version of Caphosol available for purchase.
When Will a Generic Version Be Available?All generic medications must undergo certain tests to compare them to brand-name medications. The U.S. Food and Drug Administration (FDA) then looks at these tests to decide if the generics are equivalent to the brand-name medications and assigns each generic medication an equivalence rating. These ratings are used by pharmacists to determine whether generic products are equivalent to (the same as) brand-name products.
The FDA considers Caphosol a medical device. Unlike medications, medical devices generally do not have chemical effects on the body. The FDA does not assign equivalence ratings to medical devices.
Because medical devices do not have equivalence ratings, it can be difficult to determine if two similar products are actually bioequivalent (meaning they work in the same way in the body). This means that, technically, there are no generic medical devices in the same way there are generic medical drugs. It should be noted, however, that there are a variety of saliva substitute products available. Even though these products are not generic versions of Caphosol, they work in a similar manner.