On 15 October 2025, the Swedish competition authority (Konkurrensverket) announced that it would discontinue its investigation into the alleged excessive pricing of Namuscla (mexiletine), an orphan medicine approved for treatment of inherited muscle disorders (Non-Dystrophic Myotonia – NDM).  Namuscla is marketed by Lupin and distributed in Sweden by Macure Pharma.

The investigation was triggered by the authority’s 2023-2024 study addressing “repurposed” orphan medicines, particularly older generic medicines originally developed and sold for the treatment of a different disease, but also used off-label for the orphan indication.  In recent years, some companies have compiled evidence and obtained orphan medicine status and EMA approval for the marketing of these medicines in the orphan indications.  The companies have thereafter launched the new medicines, which have market exclusivity, at higher prices than the older generic therapies.

With respect to Namuscla, the authority found that its orphan designation, EMA approval and launch in Sweden led to an eight- to eleven-fold increase in treatment costs compared to the prior off-label use of generic mexiletine.  Nevertheless, the investigation revealed that the prices charged for Namuscla were not clearly excessive relative to the costs incurred by Lupin to obtain EMA approval, and therefore discontinued the case.

Timeline of Key Events

• Pre 2018 – Off-label use of generic mexiletine.  Prior to Namuscla’s approval, doctors treated NDM with generic myotonia approved for cardiac arrhythmia.
• October 2018 –  Namuscla EMA Approval.  As an orphan medicinal product, Lupin also received 10 years of market exclusivity for NDM.
• 2021 – Sweden launch.  As the price of Namuscla was significantly higher than generic mexiletine, which could no longer be prescribed for NDM, treatment costs rose eight- to eleven-fold.
• 2023-2024 – Study of repurposed orphan medicines.  The authority’s study noted the substantial increased cost of treating NDM and raised excessive pricing concerns.
• May 2024 – Start of formal investigation of Namuscla.  The authority initiated its investigation of the pricing of Namuscla by Lupin and Macure Pharma.

The Decision

The Swedish competition authority found that Lupin likely held a dominant position as the exclusive producer of mexiletine for the treatment of NDM, for which no other therapies were approved or available in Sweden.  The authority therefore applied the United Brands framework to evaluate whether the pricing of Namuscla was excessive and constituted an abuse in violation of EU and Swedish competition law.

Under the United Brands framework, a price may constitute an abuse if both of the following are satisfied:

• Is the price excessive relative to the parties’ costs?  The authority’s price-cost test did not conclusively show that the price of Namuscla was excessive relative to costs.  Lupin’s regulatory costs to obtain EMA approval were high, while sales of Namuscla were lower than forecast, which resulted in a higher cost per unit.
• Is the price unfair?  While the authority did not reach a conclusion on whether the price is unfair, it noted that the price increased significantly, and it was unclear whether Namuscla offers benefits to customers that justify the increased costs.  The authority also noted that the increased price led to fewer NDM patients receiving mexiletine.

As the evidence did not satisfy both limbs of the test (particularly the cost-based test), the Swedish competition authority discontinued the investigation, while also reserving its right to further investigate the pricing of Namuscla should market circumstances change.

Key Takeaways

This decision illustrates that even a price increase of 800% – 1100% does not automatically constitute an abuse under the competition laws.  Each case must be assessed on its specific facts and economic context.  It also shows that competition law is not a substitute for sectoral regulation: structural issues in the EU orphan medicine framework may be better addressed through legislative reform to ensure that incentives truly deliver value for patients and health systems.

For companies, the case also serves as a reminder that large price increases – particularly for products benefiting from regulatory exclusivity – will attract close scrutiny from competition authorities.  Companies should ensure that any such increases are well-documented and objectively justified, whether by reference to underlying cost structures (e.g., R&D or regulatory approval costs) or to the value created for patients and health systems.

In practice, companies should also regularly update their competition-law assessments as market conditions evolve.  In this instance, Lupin’s position was arguably strengthened by lower-than-expected sales volumes, which raised per-unit costs and helped justify a higher price.  Had sales volumes instead been higher – reducing the cost per unit – the same price could have appeared excessive, potentially leading to an adverse finding and fines, as seen in the Leadiant cases in the Netherlands, Italy, and Spain.