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Explainers
The rules behind when a product opens up, explained for the people who source, launch and buy medicines. Each piece is sourced to the legislation or register it describes and reviewed every year. Read them in order, or jump to the one you need.
Also in Guides: Prices (7) · Glossary (3) · News: Case notes (11) · Regulatory changes (3)
Start here · 2 min read · Reviewed 24 October 2026
One product, five clocks: the dates that decide when a medicine opens up
Patent expiry, SPC expiry, paediatric extension, data exclusivity and market protection are five separate clocks on one product. They start from different events, run under different laws, and the last one to stop sets the real loss-of-exclusivity date. A one-page map, with a checklist.
4 min read · Reviewed 24 October 2026
Patent cover, data exclusivity and market protection: three clocks, one product
Patents are only one of the barriers between a generic and the market. Regulatory data protection runs on its own clock from the first EU authorisation and can block generics when no patent does. What the 8+2+1 rule means, how the UK and EU now differ, and what the 2026 reform changes.
3 min read · Reviewed 24 October 2026
Types of pharmaceutical patent, and what each one actually blocks
Compound, formulation, use, process, polymorph and combination patents protect different things and expire at different times. 'The patent has expired' is rarely the whole story. What each type covers, which ones carry SPCs, and how to read a product's patent stack.
4 min read · Reviewed 24 October 2026
Supplementary protection certificates: how the SPC term is calculated
SPCs add up to five years to a pharmaceutical patent. The rule that sets the exact term is short, but the inputs are not, and the answer differs by country. A plain walk-through with worked examples, and what to check before relying on an SPC date.
3 min read · Reviewed 24 October 2026
Paediatric extensions: the extra six months, and how to check for one
An extra six months on an SPC, granted to originators that complete an agreed paediatric investigation plan. Small on paper, large in revenue, and a frequent surprise for generics and parallel traders who planned on the SPC date. How it works and where to look.
3 min read · Reviewed 24 October 2026
Patent term extension: the US PTE, the EU SPC and the UK compared
The United States extends the patent itself; Europe grants a separate certificate. The two systems are often confused in global launch plans and in press coverage. What each extends, by how much, on what conditions, and why a US date tells you nothing about Europe.
3 min read · Reviewed 24 October 2026
The SPC manufacturing waiver: what it allows and what it does not
Since 2019 generics and biosimilars may be made in the EU during the SPC term for export outside the EU, and stockpiled in the last six months for day-one launch. The conditions, the notifications, and why it changes manufacturing plans more than launch dates.
3 min read · Reviewed 24 October 2026
The Unified Patent Court and the unitary patent: what changed for pharmaceuticals
Since June 2023 one court can revoke, or enforce, a European patent across most of the EU in a single decision. Which countries are in, what the opt-out means, why there is still no unitary SPC, and how to read a product's position in a Europe that is now two systems.
2 min read · Reviewed 24 October 2026
Centralised, decentralised, mutual recognition, national: the four routes and what they mean for exclusivity dates
A medicine reaches the European market by one of four procedures. Each produces a different kind of authorisation, a different number format, and a different first-authorisation date. What the routes are, how to recognise them from a licence number, and why the route matters for SPC and exclusivity calculations.
3 min read · Reviewed 24 October 2026
Why the expiry date is not the launch date in Europe (and what is)
A patent or SPC expiry date on a register is the start of the answer, not the end. Between it and the first generic pack on a shelf sit secondary patents, paediatric extensions, regulatory clocks, pricing procedures and litigation, and they differ by country. The steps, in order, and where each one can move the date.
2 min read · Reviewed 24 October 2026
Why published patent-expiry lists disagree, and how to check a date yourself
Search for any blockbuster's European patent expiry and you will find three different years. The lists are not all wrong; they are measuring different things. The six reasons they diverge, and a short procedure for getting the date that applies to your product and country.
4 min read · Reviewed 24 October 2026
What breaks when you track loss of exclusivity in a spreadsheet, and what to do instead
Most companies start with a spreadsheet of products and expiry dates, and most of those spreadsheets are wrong within a year. The seven ways they fail, from one row per product to dates typed rather than calculated, and the structure, rules and review cadence that keep a loss-of-exclusivity list honest, whether it stays in Excel or not.
4 min read · Reviewed 24 October 2026
From SPC expiry to first generic supply: the work in between, in the UK and Europe
The exclusivity date is when a generic may be sold, not when it is on the shelf. What has to be in place by that day: the authorisation filed at year eight, pricing and reimbursement country by country, tender calendars, packs, stock and the patent position, and why first supply lands within days in some markets and a year later in others.
5 min read · Reviewed 24 October 2026
Clearing the path, launching at risk and preliminary injunctions: how generic launches are fought in the UK, Germany and the UPC
When a patent is still asserted at the exclusivity date, a generic either clears it first or launches and defends. What each route involves, how the UK, German and Unified Patent Court approaches to preliminary injunctions differ, what a cross-undertaking in damages is, and what an 'injunction granted' headline means for supply.
4 min read · Reviewed 24 October 2026
Plausibility: the ground that has felled UK compound patents, explained for commercial readers
Apixaban and dapagliflozin lost their UK patents and SPCs years early on 'plausibility': the application did not make it credible, when it was filed, that the compound would work. What the test is, why it bites in the UK more than at the EPO, which patents are exposed, and what it means for launch and sourcing dates.
3 min read · Reviewed 24 October 2026
Why some SPC expiry dates moved by a few days: the notification-date rule, and how to check a register entry
Since the Court of Justice's 2015 Seattle Genetics ruling, the SPC term for a centrally authorised product is counted from the day the holder was notified of the Commission's decision, not the decision itself. The difference is days, every SPC on that authorisation moves by them, and the registers did not all correct themselves. How the rule works, what Incyte added, and how to check.
4 min read · Reviewed 24 October 2026
Biosimilars in Europe: the exclusivity rules, the pathway and why launch timing differs from small molecules
Biosimilars face the same data protection and SPC rules as generics, but their launches look different: they cluster on the SPC date, they are fought on process and formulation patents, uptake runs through tenders rather than pharmacy substitution, and development takes years longer. What a trader, planner or buyer needs to know that the small-molecule rules do not say.
4 min read · Reviewed 24 October 2026
Orphan market exclusivity in the EU: ten years, the exceptions, and what the reform changes
An orphan medicine gets ten years in which no similar product can be authorised for the same indication, a clock that runs separately from data protection, patents and SPCs. How it works, when it is cut to six, when a competitor can get in anyway, why a generic can still launch for other indications, and the tiered periods the EU pharmaceutical package brings in.
3 min read · Reviewed 24 October 2026
Second medical use patents and skinny labels: what a generic can sell, and what the pregabalin case settled
When the compound is free but one of its uses is still patented, a generic launches with that use cut out of its label. What a second-medical-use patent claims, how the carve-out works, why the UK pregabalin litigation turned on how a product is presented rather than what it is used for, how Germany and the Netherlands differ, and what it means for prescribing, dispensing and sourcing.
4 min read · Reviewed 24 October 2026
How long a European patent lasts, country by country: validation, renewal fees and lapses
A European patent is granted once and then lives as separate national rights, each of which can be in force, lapsed, revoked or never created. Why the same EP number expires on different dates in different countries, what validation and renewal fees do, where the unitary patent fits, and how to read 'in force' on a register.
4 min read · Reviewed 24 October 2026
Paragraph IV, 30-month stays and 180-day exclusivity: why US generic timing does not transfer to Europe
Most English-language writing about generic entry describes the US system, and most of it is wrong for Europe. The Orange Book, patent linkage, the 30-month stay and first-filer exclusivity have no European equivalents; data protection runs from a different date; and litigation works by injunction, country by country. A side-by-side guide for readers who meet US terms in their sources.
4 min read · Reviewed 24 October 2026
The generic development timeline in Europe: how long each step takes and when the exclusivity clocks bite
A generic cannot be filed until year eight of the reference product's data protection and cannot be sold until year ten, so development is timed backwards from a date. What each step takes for an oral solid, where the Bolar exemption covers it, what the application costs in time, why complex generics and biosimilars start years earlier, and what the programme means for the launch date everyone else is watching.
5 min read · Reviewed 24 October 2026
Medicine shortage registers in Europe: who publishes what, and how to read them
Every European country now publishes some record of medicines in short supply, and no two mean the same thing by 'shortage'. The EU-level sources, the national registers and export-restriction lists country by country, what each actually records, and how traders, buyers and planners should read them.
4 min read · Reviewed 24 October 2026
Unlicensed medicines: the routes in the UK and Europe (specials, imports, named-patient and compassionate use)
A medicine with no marketing authorisation in a country can still reach a patient there, by one of several routes that each have their own rules, suppliers and prices. What the EU's named-patient and compassionate-use provisions allow, how the UK's specials and import notifications work, how the large member states run early access, and what the routes mean for traders, planners and buyers.