Overview of LNG IUS Products Approved by a Stringent Regulatory Authoritya

SupplierSRA-Approved LNG IUS ProductAvailability and Pricing in FP2020 Countries
Bayer HealthcareMirenabMirena is provided commercially through private health care clinics in some developing countries on a very limited basis. Pricing between ∼US$60–$400 has been documented in recent market assessments in urban settings in Kenya, Madagascar, Nigeria, and Zambia.1215
International Contraceptive Access (ICA) FoundationUnbranded LNG IUS productThrough a public-private partnership between Bayer HealthCare and Population Council, a free unbranded LNG IUS product is provided by donation. Registered in several countries; brought in via regulatory waivers in other countries.
Medicines360Sold in the United States under trade name Liletta; being registered in FP2020 countries under the trade name AvibelaThe public-sector price to distributors for Avibela will vary by volume between US$12–$16; for an order of 100,000 units, public-sector transfer price will be approximately $15/unit. As of mid-2018, registered in Madagascar and Zambia.
  • Abbreviations: FP2020, Family Planning 2020; LNG IUS, levonorgestrel intrauterine system; SRA, stringent regulatory authority.

  • a In addition to the products listed in the table, there are several LNG IUS products that are being introduced in a limited number of FP2020 countries that are not currently approved by an SRA. As of 2018, there are no LNG IUS products that have been prequalified by the World Health Organization.

  • b Bayer Healthcare also manufactures the LNG IUS products Skyla and Kyleena. However, these products are not yet available in low- and middle-income countries, and therefore are not discussed here.