Semaglutide (Ozempic, Wegovy): why generics abroad do not mean generics in Europe

What was decided

Semaglutide is protected in Europe by a compound patent, extended by national SPCs, and by a thicket of secondary patents covering formulations, dosing and uses. Generic companies have been attacking the secondary patents through oppositions at the European Patent Office rather than in court, because an EPO revocation removes the patent in every country at once.

The results so far are mixed. EP 2 866 825, on the use of long-acting GLP-1 peptides for obesity, was revoked by an Opposition Division in 2022 and the Board of Appeal confirmed the revocation in 2025 for lack of inventive step, on an opposition by Teva, Generics (UK) and Galenicum. In autumn 2024 the Boards of Appeal revoked two patents on oral semaglutide (Rybelsus). Against that, the EPO upheld EP 3 746 111, a tablet formulation patent, and maintained a cardiovascular-use patent in amended form, which the opponents have appealed.

None of this touches the compound protection. Commentators put European generic entry at around 2031, because the compound patent is extended by SPCs that have no equivalent in several countries where generics are launching in 2026.

Timeline

Date	Event
May 2022	EPO Opposition Division revokes EP 2 866 825
Autumn 2024	Boards of Appeal revoke two oral-semaglutide patents
May 2025	Board of Appeal (T 1701/22) confirms revocation of EP 2 866 825
2025	EPO upholds the tablet formulation patent EP 3 746 111; cardiovascular-use patent maintained as amended, under appeal
2026	Generic semaglutide launches reported in Canada, Brazil and India; Dr Reddy’s plans 87 countries
About 2031	Expected European loss of exclusivity, subject to SPC and paediatric extension dates by country (to be confirmed)

What it means if you are…

A parallel trader. Generic semaglutide from Canada or India cannot be parallel imported into the EU or the UK. Parallel import needs a product authorised in the exporting EEA country (or, for the UK, a product with a UK parallel import licence based on an EEA authorisation), and no patent or SPC in force in the destination. Neither condition is met before the European SPCs expire. Headlines about cheap semaglutide abroad are not a sourcing opportunity in Europe.

A generics or launch planner. The EPO route is working on the periphery and not at the core. Each revoked secondary patent removes a future obstacle, but the launch date in each European country is set by that country’s SPC on the compound patent, plus any paediatric extension. Build the launch plan from the SPC register country by country, and treat EPO wins as clearing the path for the day after.

A wholesaler or buyer. No European price event before the early 2030s on current information. Shortages and quotas, not patents, are what move the semaglutide market in Europe for now.

Status and what to watch

Pending EPO appeals on the surviving secondary patents; any UK or UPC litigation as European expiry approaches; and the SPC and paediatric extension dates on each national register, which will set the actual order in which European markets open.