Solutions · For Business Development

Time your loss-of-exclusivity moves

The value of a move often hinges on a date: when data protection lapses, when an exclusivity period ends, when the path to market opens. Regunaut maps those dates across your targets so you can plan generic entry, launches and lifecycle moves around them.

Loss of exclusivity

Protection periods become opening windows

Dates decide
ClosedOpen
Target AData protection
Q3 2026
Target BMarket exclusivity
2027
Target DOpen pathway
Open now

Outcome

One launch calendar you can plan against

Data protection, market exclusivity and SPC clocks reduce to one practical date per target: when the move can happen.

The problem

Exclusivity dates are scattered, technical, and easy to misjudge

Data protection, market exclusivity and supplementary protection each run on their own rules and clocks, and the 2026 EU Pharma Package changes how those periods work. Reconstructing the real loss-of-exclusivity date for each target by hand is slow and error-prone, and mistiming it can cost the launch window.

How it works

From protection rules to a launch calendar

1

Pick your targets

Choose the products or molecules you're planning around, whether your own assets or competitor reference products.

2

Workbench maps the protections

It works out the applicable data-protection, market-exclusivity and SPC periods under the current framework, and the date each one lapses.

3

Plan moves around the dates

See a clear timeline of when each path to market opens, so generic entry, launches and lifecycle moves land at the right moment.

Workbench scenario

Convert exclusivity rules into entry windows

Workbench lays out the protection clock and the practical date when each move opens.

Workbench
+ New Task
Solution scenario/Entry-window calendar

For these three target products, when do data protection, market exclusivity and SPC barriers clear enough for a generic-entry plan?

Regunaut
Regunaut12:39
35.05s8 sources94% confidence1 warning
1 warning

Executive summary

Target D can move into launch planning now. Target A needs a Q3 2026 readiness gate. Target B should stay out of the active plan until 2027.

The important detail is that each target is blocked by a different protection layer. One generic LoE date would hide the real constraint and make the launch plan look cleaner than it is.

Workbench separates data protection, market exclusivity and SPC risk first, then turns the timing analysis into practical launch moves for each target.

Entry-window calendar

Each recommendation carries its reasoning and a source trail, so the result can go straight to RA, BD or the product owner.

Timing
Filter table...3 rows
ItemWorkbench readStatus
Target DProtection lapsed; move to launch and filing plan.Ready
Target AData protection lapses in Q3 2026; start dossier readiness now.Needs review
Target BMarket exclusivity keeps the path closed until 2027.Check
3 target productsAtlas target listEU exclusivity rulesSPC and MA records
Why Regunaut

Exclusivity planning without the guesswork

Get the date right

Protection periods are worked out from the rules, so plans rest on accurate timing rather than approximations.

Current with the law

Built around the evolving EU framework, so your dates reflect the rules that will actually apply.

Move at the right moment

Time entry and launches to opening windows instead of arriving early or late.

Exclusivity timing your launch plan can rely on.

Plan around the dates that matter

See how Regunaut maps data protection and exclusivity so you can time every move.

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