EU/3/04/241: Orphan designation for the treatment of idiopathic pulmonary fibrosis



On 16 November 2004, orphan designation (EU/3/04/241) was granted by the European Commission to Uppsala Medical Information System AB, Sweden, for pirfenidone for the treatment of idiopathic pulmonary fibrosis.

Pirfenidone has been authorised in the EU as Esbriet since 28 February 2011.

The sponsorship was transferred to Intermune Europe Limited, United Kingdom, in May 2009. Intermune Europe Limited has changed its name to InterMune UK Limited in March 2011.

The sponsorship was transferred to Roche Registration Limited, United Kingdom, in February 2015 and subsequently to Roche Registration GmbH, Germany, in March 2018.

Please note that this product was withdrawn from the Community Register of designated orphan medicinal products in March 2021 at the end of the 10-year period of market exclusivity.

Key facts

Active substance
Medicine name
Intended use
Treatment of idiopathic pulmonary fibrosis
Orphan designation status
EU designation number
Date of designation

Roche Registration GmbH
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen

Review of designation

During its meeting of 8-9 February 2011, the Committee for Orphan Medicinal Products (COMP) reviewed the designation EU/3/04/241 for Esbriet (pirfenidone) as an orphan medicinal product for the treatment of idiopathic pulmonary fibrosis. The COMP assessed whether, at the time of marketing authorisation, the medicinal product still met the criteria for orphan designation. The Committee looked at the seriousness and prevalence of the condition, and the existence of other satisfactory methods of treatment. The COMP recommended that the orphan designation of the medicine be maintained*.

*The maintenance of the orphan designation at time of marketing authorisation would, except in specific situations, give an orphan medicinal product 10 years of market exclusivity in the European Union. This means that in the 10 years after its authorisation similar products with a comparable therapeutic indication cannot be placed on the market.

Documents related to this orphan designation evaluation

  • List item

    Recommendation for maintenance of orphan designation at the time of marketing authorisation: Esbriet (pirfenidone) for the treatment of idiopathic pulmonary fibrosis (PDF/120.04 KB)


    First published: 11/03/2011
    Last updated: 11/03/2011

  • 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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