Why the expiry date is not the launch date in Europe (and what is)

The date on the register

Take a product whose compound SPC expires on 14 March 2028 in Germany. That date is accurate, public and, on its own, almost useless for deciding when a generic will be sold there or when a parallel trader can expect the German price to fall. Here is what sits between the register and the shelf.

Seven things that move the date

1. Secondary patents. The compound SPC date is when the molecule is free. Formulation, use, polymorph and combination patents filed later can still be in force. Whether they block a specific generic depends on what that generic is and does, and on whether anyone has challenged them. Rivaroxaban’s once-daily dosing patent, not its compound SPC, decided the UK launch date, and decided it differently from Germany.

2. Paediatric extension. Six months on the SPC, in each country where it is granted, applied for up to two years before SPC expiry. A register that shows no extension today can show one next year.

3. Regulatory data protection. Eight years of data exclusivity and two (soon one, with extensions) of market protection from the first EU authorisation. For most compounds this ends before the SPC and is invisible; for products authorised quickly or whose patents fell, it is the binding date, and it cannot be litigated.

4. Litigation. The date can move earlier, as when the UK revoked dapagliflozin’s SPCs three years before their expiry, or later, as when a first-instance revocation is reversed on appeal. It moves country by country outside the UPC and in one go inside it.

5. Authorisation. The generic needs its own marketing authorisation in each country, usually via the decentralised procedure. Applications can be filed once data exclusivity ends and are normally in hand well before SPC expiry, but a late or disputed authorisation delays the launch regardless of the patent position.

6. Pricing and reimbursement. In most European countries a generic cannot be sold at a reimbursed price until a national pricing or reimbursement procedure has run, which can take from weeks to many months after authorisation. Under the UPC’s 2025 nintedanib reasoning, starting that procedure before SPC expiry can itself be treated as a threat to infringe, so the procedure is often begun late and the launch follows expiry by the procedure’s length. The 2026 EU pharma package’s wider Bolar exemption is intended to let these steps happen during the protected period; it is not yet in force.

7. Supply. With the manufacturing waiver, European generics can be stockpiled in the last six months of the SPC and launched on day one; without it, or for non-EU manufacturers, product has to arrive. Tender timetables in hospital markets add their own calendar.

So what is the launch date?

For each country, the launch date is the latest of: the last patent or SPC that the generic actually infringes and that has not been revoked; the end of regulatory protection; the generic’s own authorisation; and the end of its pricing procedure. The first of those is the only one that appears on a patent register.

The practical consequence is that the same product opens on different dates in different countries, often by a year or more, and that the earliest date in Europe is frequently the UK, where plausibility challenges have succeeded and where the pricing step (Drug Tariff listing) is fast.

What it means for you

Launch planners: build the plan as the four-date maximum above, per country, and keep the litigation watch running; the register date is an input, not the output.

Parallel traders: the asymmetry between countries is the opportunity, and it comes from items 1, 4 and 6 more than from the SPC date itself. Watch where a generic is actually on the market, not where the SPC has expired.

Buyers: the price event follows the first generic sale, not the expiry date; in the UK it follows the Drug Tariff category change a few weeks later. Plan stock on the former, budgets on the latter.

MPA Search holds the patent, SPC and paediatric dates and the first EU authorisation per country, which covers items 1 to 3; the case notes track item 4; and the country guides describe item 6 for each market.