Novo Nordisk Wins Dutch Court Injunction Against Compounded Semaglutide Nasal Spray

What happened

On August 5, the District Court of The Hague granted Novo Nordisk a preliminary injunction against Ceban Ziekenhuisfarmacie B.V., a hospital pharmacy in Breda, Netherlands, ordering it to stop distributing a compounded semaglutide nasal spray marketed under the brand name Semanova. The court ruled that Ceban infringed Novo Nordisk's Dutch Supplementary Protection Certificate (SPC) 300936, which covers semaglutide and remains in force until March 19, 2031-approximately five years beyond the March 2026 expiry of the underlying European compound patent. Ceban was ordered to cease all distribution, remove the product from the G-Standard Dutch pharmaceutical database, recall units supplied to other pharmacies, disclose its commercial customers and Chinese API supplier within four weeks, and reimburse Novo Nordisk €50,053.77 in legal costs. Penalty payments for non-compliance are capped at €500,000. No nasal spray formulation of semaglutide has been approved by any regulatory authority worldwide; approved delivery mechanisms are subcutaneous injection (Wegovy and Ozempic) and oral tablet (Rybelsus).

Why it matters

The ruling clarifies that the widely reported 2026 patent expiry for semaglutide-which enabled generic competition in India, Brazil, and China-does not apply in most of the European Union, where country-specific Supplementary Protection Certificates extend exclusivity beyond base patent expiry. For the Netherlands, this means Novo Nordisk retains monopoly protection on semaglutide through March 2031, blocking generic or compounded alternatives for approximately five additional years. The decision also establishes that Dutch courts will interpret the pharmacy exemption narrowly: Ceban's activities-importing 600 grams of API (enough for approximately 15,000 vials), branding the product, registering it in prescribing databases, and reselling to other pharmacies-were deemed commercial-scale operations, not individual-patient compounding. This precedent makes clear that European compounders cannot replicate the pricing competition that has emerged in non-EU markets. For investors, the ruling protects a significant portion of Novo Nordisk's obesity care revenue base, which totaled approximately DKK 82 billion ($12.7 billion USD) in 2025, by maintaining branded pricing power in Europe through the end of the decade.

Bigger picture

Novo Nordisk is conducting a coordinated multi-country enforcement campaign across Europe to defend its semaglutide portfolio. In October 2025, the company obtained preliminary injunctions at the CPHI pharmaceutical trade fair in Frankfurt against exhibitors-mostly from Asia-marketing unapproved semaglutide products. The Regional Courts of Düsseldorf and Frankfurt issued additional ex parte injunctions. At the European Patent Office, Novo Nordisk successfully defended EP 3 746 111 B1, which protects oral semaglutide bioavailability improvements, but lost several other patents covering tablet formulations (EP 2 827 845, EP 2 827 885, EP 2 866 825), narrowing but not eliminating its oral formulation IP. SPCs, by contrast, cannot be revoked by the EPO-they are national instruments challengeable only through national proceedings. The asymmetry between European and non-European markets is stark: in Brazil, five generic semaglutide injection pens cleared regulatory review in a single day in July 2026, and genuine price competition is underway. In India, generic manufacturers sought approval almost immediately after the March 20, 2026 compound patent expiry. European patients hoping for similar access face a significantly longer wait. The Dutch Health and Youth Inspectorate is separately reviewing whether Ceban violated the Medicines Act, with a decision expected by October 2026.

What to watch

Monitor whether Ceban appeals the preliminary injunction and whether the Dutch Health Inspectorate's separate Medicines Act review, expected by October 2026, results in additional regulatory penalties. Watch for similar enforcement actions in other EU member states where Novo Nordisk holds SPCs-expiry dates vary by country, but the legal framework is harmonised under EU Regulation 469/2009. Track whether generic manufacturers mount legal challenges to individual national SPCs or whether they wait for the exclusivity period to expire naturally. Observe pricing and access developments in markets where semaglutide exclusivity has ended-Brazil, India, and China-as these provide a preview of the competitive dynamics that will eventually reach Europe. Monitor Novo Nordisk's full-year 2026 outlook updates, particularly obesity care product sales and Wegovy pill prescription volumes, which had accumulated more than 5 million prescriptions since US launch, with more than 265,000 weekly prescriptions recorded for the week ending July 17. Watch for FDA updates on adverse event reports related to compounded semaglutide, which totaled 990 reports as of May 31, 2026, many involving dosing errors.