You can now buy 0.5-mg Rapamune (sirolimus) tablets in generic form. These products are considered to be equivalent to brand-name Rapamune. The other strengths of the drug are available as brand-name products only, and it's unclear when they will become available in generic form.
Rapamune® (sirolimus) is a prescription medication used after a kidney transplant to prevent the body from rejecting the new kidney. It belongs to a group of medicines called immunosuppressants.
Rapamune is made by Pfizer, Inc., and distributed by Wyeth Pharmaceuticals, Inc., a subsidiary of Pfizer, Inc. One strength of Rapamune is available in generic form.
The generic version of this medication is available in one strength: Sirolimus 0.5 mg tablets. The other strengths (1-mg tablets, 2-mg tablets, and oral solution) are not yet available in generic form. It is not clear when exactly they may become available.
Generic Rapamune is made by various manufacturers, such as:
- Greenstone LLC
- Zydus Pharmaceuticals.
The version sold by Greenstone LLC is actually an "authorized generic," meaning it is the actual brand-name medication that is just packaged and sold under a generic name. It is exactly the same as Rapamune in every way (it is even made by the same company), except it comes in a bottle with a generic name.
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 a rating to each one.
An "AB" rating means that the FDA has determined that a generic medication is equivalent to a brand-name medication. All of the generic versions of Rapamune currently available have an "AB" rating, meaning they should be equivalent to brand-name Rapamune. The version sold by Greenstone LLC does not have a rating because it is an authorized generic and is simply the brand-name drug repackaged.
However, generic medications are allowed to have different inactive ingredients than the brand-name medication. This might include fillers, dyes, or other ingredients that may cause problems for people with allergies or sensitivities.