Companies are not allowed to make generic versions of Kalydeco (ivacaftor), as this drug is protected by a patent. The earliest estimated date when a generic version might become available is May 2027, when the first patent is expected to expire. Because this is an expensive medication, talk to your healthcare provider about ways to help paying for it.
Can I Buy Generic Kalydeco?Kalydeco™ (ivacaftor) is a prescription medication used to treat cystic fibrosis. While it is an exciting breakthrough for cystic fibrosis treatment, Kalydeco is only effective in people who have certain mutations, including G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, or S549R. Kalydeco is not effective in people with the most common CF mutation (known as F508del mutation).
Kalydeco is manufactured for Vertex Pharmaceuticals Incorporated. It is currently under the protection of a patent that prevents any generic Kalydeco from being made in the United States.
When Will a Generic Version Be Available?The first patent for Kalydeco is set to expire in May 2027. This is the earliest predictable date that a generic version could become available.
However, this could change, depending on many factors, such as lawsuits or additional patents for new Kalydeco uses. Once the drug goes off-patent, there may be several companies that will manufacture a generic Kalydeco product.
Is Ivacaftor a Generic for Kalydeco?No -- ivacaftor is the active ingredient in Kalydeco, not a generic version of it. What can be confusing is that the active ingredient of a drug is often referred to as the "generic name."
The generic name is different from a generic version of a medicine. In order for there to be a generic version, the original medicine must have gone off-patent, and another company besides the original manufacturer must make the product.
Kalydeco is exceptionally expensive. Your healthcare provider, pharmacist, and even the manufacturer of Kalydeco can help you determine if this drug will be covered by your insurance. They can also help with "prior approval" or other difficulties you may encounter with getting Kalydeco covered by your insurance.