Generics and biosimilar companies
Your launch plan is timed to a date, and the date is different in every country. MPA gives you the patent, SPC and exclusivity position for each market from the registers, the licences and demand around it, and people who have read the judgments.
The questions you face
When does the molecule actually open up in the UK, Germany, France and the other markets we care about, allowing for SPCs and paediatric extensions?
Which secondary patents, formulation, use or process, still stand in the way, and which of them have been litigated?
How big is the opportunity: how much is prescribed, where, and at what value, before the field crowds?
Who else is coming, and which licences and authorisations have already been granted or applied for?
How MPA helps
The official data, kept current, with the experience to read it. We have done this since 1973.
The clocks, country by country
Patents, SPCs, paediatric extensions and first EU authorisation dates for products across 32 countries, each with the register reference, maintained as the registers change.
Licences, prices and demand alongside
UK and European licences, published list prices and NHS prescribing data for England in the same search, so an opportunity can be sized and the competition seen in one place.
Experience on the end of an email
When a date looks wrong, a patent is under attack or a register entry is unclear, we explain what it means for your launch. Included in every subscription.
“Having used MPA over many years it has formed a key part of our business planning process. The data provided allows my team to make product identification clearly targeted.”
What to read first
All resources- ExplainersOne product, five clocksPatent 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.
- ExplainersFrom SPC expiry to first generic supplyThe 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.
- ExplainersClearing the path, launching at risk and preliminary injunctionsWhen 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.
- ExplainersPlausibilityApixaban 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.
- ExplainersThe generic development timeline in EuropeA 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.
- ExplainersBiosimilars in EuropeBiosimilars 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.
See MPA Search in action
A free online demonstration with our team, with time for your questions.