Brand-name Makena (hydroxyprogesterone caproate) is protected from generic competition until at least February 2018. However, it should be noted that compounding pharmacies have been providing hydroxyprogesterone injections since before Makena was even approved. For the time being, the FDA has given special permission for certain pharmacies to continue providing hydroxyprogesterone injections.
Makena™ (hydroxyprogesterone caproate) is an injectable medication used to prevent preterm births. It is a long-acting, synthetic (manufactured) version of the hormone progesterone. Makena is the first and only medication approved by the United States Food and Drug Administration (FDA) for this use.
Brand-name Makena is manufactured by Ther-Rx Corporation. It is protected by certain exclusivity rights that prevent a generic version from being commercially available. However, "compounded" versions of the medication may still be available in certain pharmacies.
Makena is not protected by any unexpired patents; instead, it is protected from generic competition by "Orphan Drug Exclusivity" (ODE). The FDA may grant ODE status to medications used to treat rare diseases. ODE provides seven years of protection against generic competition. In the case of Makena, this protection lasts until February 2018.
The manufacturer of this medication is committed to helping women afford it. They will work with you, your insurance, available state assistance programs (such as Medicaid), and any other options to help you afford Makena.
They will help you obtain prior authorization with your insurance company, if necessary. They can also provide financial assistance for eligible women. This process is started automatically when your healthcare provider prescribes Makena and registers you with the Makena Care Connection™, which is required to receive the medication.