simeprevir sodium · Janssen Prods · NDA 205123

Olysio

Earliest generic entry, as listed
5 Sep 2029

No marketed reference-listed strength; date taken from all listed strengths.

Blocked by patent: US 8148399.

Listed patents · 1 unexpired

PatentClaimsExpires
US 8148399substance, product, use U-14675 Sep 2029

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 · 1

NDA · productFormStrengthListed expiry
205123 · 001 · RLD · discontinuedcapsule, oralEQ 150MG BASE5 Sep 2029
Expired or delisted (7)
  • US 8349869 · substance, product, use U-1467 · 28 Jul 2026
  • US 8741926 · substance, use U-1467 · 28 Jul 2026
  • US 8754106 · substance, use U-1467 · 28 Jul 2026
  • US 9040562 · substance, product, use U-1467 · 28 Jul 2026
  • US 9353103 · use U-1467 · 28 Jul 2026
  • US 9623022 · use U-1467 · 28 Jul 2026
  • US 9856265 · substance, product, use U-1467 · 28 Jul 2026