MHRA's UK reference medicines list puts exclusivity expiry dates in a downloadable file

What MHRA has published

On 6 November 2026 the Medicines and Healthcare products Regulatory Agency published a list of UK reference medicines with their data and market exclusivity expiry dates. The record describes it as a new standard. It covers products whose global marketing authorisations began between 2014 and 2021. The publication includes an explanatory note and a downloadable CSV file.

The machine-readable format is the practical change. Teams can filter, sort and merge the data with their own portfolio trackers instead of re-deriving dates product by product. The 2014-2021 window also suggests a deliberate focus on a cohort of originator products whose protection periods are expiring or may soon do so. The records do not say why that window was chosen.

Why exclusivity dates matter

Data exclusivity and market exclusivity are separate protections. In general terms, data exclusivity limits when a later applicant can rely on an originator's regulatory data. Market exclusivity limits when an approved competing product can be placed on the market. Calculating when each period ends, and when a generic or biosimilar application can be filed, approved and launched, is routine work for regulatory and market-access teams.

Those calculations have usually relied on internal interpretation of authorisation histories. This is especially true where the first global authorisation sits outside the UK. A regulator-published list gives teams a common reference point. It does not remove the need for their own analysis, but it makes discrepancies easier to spot and raise.

What the records do not tell us

The available description is short, and several points that determine the list's practical value are not stated. It is not yet known how the list treats products with additional or extended protection. It is also unclear how it handles products whose UK authorisation date differs from the global one, or how often it will be updated. Whether it is intended as an authoritative statement or as guidance to be read with the explanatory note is not set out either.

Teams should read the explanatory note before relying on any date in the CSV. They should also keep a record of where their own calculation differs from the published one, because the reasons will matter if a launch or filing decision is ever questioned.

Other regulatory signals this week

The exclusivity list arrives alongside other items that show how lifecycle planning runs across jurisdictions. In Spain, AEMPS published its October 2026 CHMP bulletin, listing positive opinions for orforglipron, daraxonrasib and navepegritide, plus five changes to products already authorised in the EU. Products that win authorisation in the EU will eventually generate their own protection timelines in each market where they are approved. Any UK date for them would depend on the UK authorisation history, which is not covered here.

In the US, Protara Therapeutics moved enrolment completion for its registrational STARBORN-1 lymphatic malformations trial into early Q1 2027. It plans a rolling BLA in the second half of 2027. That is a reminder that exclusivity clocks start only after a long chain of development and filing steps.

The FDA's Office of Health Advancement agenda lists orphan designation among its topics, and the invitation for public comment is open. A separate FDA direct final rule clarifies that nonclinical testing can include cell-based assays, organs-on-chips and computer models. It does not mandate any method or change evidentiary standards.

In Denmark, bendroflumethiazide/potassium chloride 2.5+573 mg tablets were listed as in supply failure. That opens the way for equivalent foreign-labelled products under section 29(2) of the Medicines Act. Supply shortages and exclusivity are different issues, but both show how national rules shape which products can reach patients and when.

Who is affected and what to watch

The most direct users are generic and biosimilar developers, originator lifecycle teams and market-access groups that model competition. UK affiliates of multinational companies are also affected, since they often inherit global assumptions that do not map neatly onto UK dates. Any company with a product first authorised globally between 2014 and 2021 should check how it appears in the file.

Watch for how the list is used in practice, for example by pricing and procurement teams. Also watch for any update schedule, corrections, or MHRA commentary on edge cases. None of these is described in the records yet.