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Generic Levonorgestrel-Releasing Intrauterine System

There are currently no generic versions of levonorgestrel-releasing intrauterine system, as it is protected by patents that prevent any generic products from being manufactured in the United States. When the first patent for Mirena expires in December 2015 and the first patent for Skyla expires in November 2023, other companies can begin manufacturing generic versions. However, lawsuits or new patents may delay their availability.

Can I Buy Generic Levonorgestrel-Releasing Intrauterine System?

Levonorgestrel-releasing intrauterine system (Mirena®, Skyla™) is a prescription progestin-only, long-term birth control medication. It is an intrauterine device (IUD) that releases the progestin hormone levonorgestrel into the uterus for up to three to five years, depending on the particular product used.
 
There are currently two levonorgestrel-releasing IUDs on the market in the United States: Mirena and Skyla. Mirena provides birth control for up to five years. Skyla is a smaller device that provides birth control for up to three years.
 
Both Mirena and Skyla are made by Bayer HealthCare Pharmaceuticals, Inc. Both are also currently protected by patents that prevent any generic versions from being manufactured in the United States.
 

When Will a Generic Version Be Available?

The first patent for Mirena is set to expire in December 2015. The first patent for Skyla expires in November 2023. These are the earliest predictable dates that a generic version could become available for each product.
 
However, other circumstances could come up to delay or shorten this exclusivity period. This could include things such as lawsuits or other patents for new uses. Once the patents expire, several companies may begin manufacturing a generic levonorgestrel-releasing system product.
 

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Last reviewed by: Kristi Monson, PharmD
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