On 15 October 2025 the Swedish Competition Authority closed a long-running excessive pricing investigation into the pricing of orphan drug pharmaceuticals.
Orphan drugs are pharmaceuticals developed to treat rare diseases. As the sizes of the patient groups for rare or ultra-rare diseases are very small it is often not economically viable to develop new treatments for these patient groups. The European Medicines Agency has therefore been supportive of increased drug repurposing, that is, to find new uses for existing drugs to treat rare diseases. This approach can significantly lower the cost, time, and risk associated with drug development.
The Swedish Competition Authority’s investigation concerned the pricing of NaMuscla, which holds a marketing authorisation issued by the European Medicines Agency, for treatment of the ultra-rare disease non-dystrophic myotonia. Lupin invested heavily to generate the data to demonstrate the safe an effective use of an old product that was no longer on the market, to meet the needs for patients with non-dystrophic myotonia. It succeeded and received marketing authorisation issued by the European Medicines Agency.
To determine whether a price is excessive, competition authorities can compare prices and costs. The Swedish Competition Authority’s investigation confirmed that Lupin has undertaken significant investments to repurpose the drug, and following a price/cost analysis, closed its investigation into the pricing of NaMuscla.
RBB’s team led by Petter Berg
Petter BergPartner and Niklas Strand
Niklas StrandPrincipal assisted Lupin and its legal advisors Delphi.
