These are medicines with a real marketing authorisation from Europe, Canada or Switzerland that have never been approved in the United States. That gap is the opportunity: if you get one of them approved in the US to treat a rare childhood disease, the FDA awards a Priority Review Voucher — a freely transferable prize. The three SEC-verified 2026 sales went for $180M, $195M and $205M (record $350M in 2015).
Think of this as a starting shortlist, not a list of ready businesses. Every drug here clears the first gate (novel to the US), but each still needs a few human checks before it's real — shown on every card and explained when you click one.
What this list deliberately excludes. Drugs whose only overseas record is a
refused or withdrawn application are not counted here — they were never
approved abroad, so the headline claim would be false. They are kept separately as
"dossier-only" leads in funnelA_dossier_only.csv, because a dossier and human
data still exist. Before 2026-08-29 they were mixed into this list and inflated it by
roughly half.
Coverage & one caveat. The list now includes drugs authorised in individual EEA countries (via the EMA Article 57 register), not just EU-central approvals — that is why most cards show an "EEA national authorisations" count. Unlike the central register, Article 57 carries no approval-status field: presence is taken as an authorisation, so those rows can't be status-filtered the way EU-central ones are. Treat a high country count as a strong "real, established medicine" signal.
⏳ The program ends 30 September 2029. The voucher is awarded on approval, so a drug must be approved by that date — a realistic program needs to start soon. (The program briefly lapsed in Dec 2024 and was reauthorized in Feb 2026; new designations are open again.)
The ranking scores how likely a drug is to survive a week of diligence — not its chance of FDA approval. It rewards rare/pediatric relevance, a foreign rare-disease flag, approval by multiple regulators, and match confidence. It can't see freedom-to-operate, existing US orphan exclusivity, ingredient sourcing, or trial feasibility — so a high rank means "worth a closer look," never "a sure thing."
Two known gaps in the ranking, stated plainly. Orphan flags are EMA-only, so a Canadian or Swiss drug can never earn that badge and is scored down for a reason that has nothing to do with the drug. "Approved by more than one regulator" is currently always zero — not because no drug qualifies, but because EMA here is centralised-only while Canada and Switzerland list mostly nationally-approved drugs, so the sets barely overlap. Both dimensions therefore deflate every candidate roughly equally.