EU/3/20/2386: Orphan designation for the treatment of idiopathic hypersomnia

sodium oxybate / calcium oxybate / magnesium oxybate / potassium oxybate


On 6 January 2021, orphan designation EU/3/20/2386 was granted by the European Commission to Jazz Pharmaceuticals Ireland Limited, Ireland, for calcium oxybate, magnesium oxybate, potassium oxybate, sodium oxybate (also known as JZP-258) for the treatment of idiopathic hypersomnia.

Key facts

Active substance
  • sodium oxybate
  • calcium oxybate
  • magnesium oxybate
  • potassium oxybate
Intended use
Treatment of idiopathic hypersomnia
Orphan designation status
EU designation number
Date of designation

Jazz Pharmaceuticals Ireland Ltd
Fifth Floor, Waterloo Exchange
Waterloo Road
Dublin 4
Ireland D04 E5W7
Tel: +35316347800

Review of designation

The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.

Documents related to this orphan designation evaluation

Patients' organisations

For contact details of patients’ organisations whose activities are targeted at rare diseases, see:

  • European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.

  • Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe.

EU register of orphan medicines

The list of medicines that have received an orphan designation in the EU is available on the European Commission's website:

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