pasireotide pamoate · Recordati Rare · NDA 203255

Signifor Lar Kit

Earliest generic entry, as listed · earliest of 5 marketed strengths
23 May 2028

Blocked by patent: US 9351923.

Listed patents · 2 unexpired

PatentClaimsExpires
US 9351923product23 May 2028
US 7473761substance, product14 Dec 2026

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 · 5

NDA · productFormStrengthListed expiry
203255 · 001 · RLDfor suspension, intramuscularEQ 20MG BASE/VIAL23 May 2028
203255 · 002 · RLDfor suspension, intramuscularEQ 40MG BASE/VIAL23 May 2028
203255 · 003 · RLDfor suspension, intramuscularEQ 60MG BASE/VIAL23 May 2028
203255 · 004 · RLDfor suspension, intramuscularEQ 10MG BASE/VIAL23 May 2028
203255 · 005 · RLDfor suspension, intramuscularEQ 30MG BASE/VIAL23 May 2028
Expired or delisted (1)
  • US 7759308 · product · 25 Oct 2026