edoxaban tosylate · Daiichi Sankyo Inc · NDA 206316

Savaysa

Earliest generic entry, as listed · earliest of 3 marketed strengths
28 Mar 2028

Blocked by patent: US 9149532.

Listed patents · 2 unexpired

PatentClaimsExpires
US 9149532drug product · sets the listed date28 Mar 2028
US 7365205drug substance18 Apr 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

No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.

Products covered · 3

NDA · productFormStrengthListed expiry
206316 · 001 · RLDtablet, oralEQ 15MG BASE28 Mar 2028
206316 · 002 · RLDtablet, oralEQ 30MG BASE28 Mar 2028
206316 · 003 · RLDtablet, oralEQ 60MG BASE28 Mar 2028
Expired or delisted (1)
  • M-14 · 18 Oct 2026