regadenoson · Astellas · NDA 022161

Lexiscan

Earliest generic entry, as listed
2 Feb 2027

Blocked by patent: US 8106183, US RE47301.

Listed patents · 2 unexpired

PatentClaimsExpires
US 8106183drug substance · sets the listed date2 Feb 2027
US RE47301drug product · sets the listed date2 Feb 2027

Exclusivities · 0 unexpired

No unexpired exclusivities listed.

Paragraph IV certifications · 0

No Paragraph IV certification listed by FDA for this drug.

The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.

Event history

  • Enters 12-month window basis: patent · 022161-001Listed date 2 Feb 2027Detected 24 Oct 2026

Products covered · 1

NDA · productFormStrengthListed expiry
022161 · 001 · RLDsolution, intravenous0.4MG/5ML (0.08MG/ML)2 Feb 2027