cliffwatch

bupivacaine · Pacira Pharms Inc · NDA 022496

Exparel

Earliest generic entry, as listed · earliest of 2 marketed strengths
2 Jul 2044

Blocked by patent: US 12156940, US 12251468, US 12318483, US 12370142, US 12728094, US 12728095.

Listed patents · 23 unexpired

26 Orange Book listing rows for 23 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.

PatentClaimsExpires
US 12156940drug product · sets the listed date2 Jul 2044
US 12251468drug product, use U-4152 · sets the listed date2 Jul 2044
US 12318483use U-4152 · sets the listed date2 Jul 2044
US 12370142drug product, use U-4152 · sets the listed date2 Jul 2044
US 12728094drug product, use U-4152 · sets the listed date2 Jul 2044
US 12728095drug product, use U-4152 · sets the listed date2 Jul 2044
US 11918565use U-38412 Feb 2043
US 12226610use U-4148, U-4149, U-41502 Feb 2043
US 12226610 listing rowuse U-41482 Feb 2043
US 12226610 listing rowuse U-41492 Feb 2043
US 12226610 listing rowuse U-41502 Feb 2043
US 11931459use U-3839, U-384017 Mar 2042
US 11931459 listing rowuse U-383917 Mar 2042
US 11931459 listing rowuse U-384017 Mar 2042
US 11033495drug product, use U-318222 Jan 2041
US 11179336drug product, use U-325022 Jan 2041
US 11278494drug product, use U-325022 Jan 2041
US 11304904drug product, use U-334622 Jan 2041
US 11311486drug product, use U-325022 Jan 2041
US 11357727drug product, use U-338022 Jan 2041
US 11426348drug product, use U-338022 Jan 2041
US 11452691drug product, use U-343922 Jan 2041
US 11819574drug product, use U-325022 Jan 2041
US 11819575drug product, use U-325022 Jan 2041
US 11925706drug product, use U-338022 Jan 2041
US 12144890drug product, use U-403322 Jan 2041
US 12151024drug product, use U-403722 Jan 2041
US 12296047drug product, use U-418422 Jan 2041

Exclusivities · 1 unexpired

I-929new indication (3 years)9 Nov 2026

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

  • Exclusivity expires within 90 days I-929 · 022496-002Exclusivity expires 9 Nov 2026Detected 24 Oct 2026
  • Exclusivity expires within 90 days I-929 · 022496-001Exclusivity expires 9 Nov 2026Detected 24 Oct 2026

Products covered · 2

NDA · productFormStrengthListed expiry
022496 · 001 · RLDinjectable, liposomal, injection133MG/10ML (13.3MG/ML)2 Jul 2044
022496 · 002 · RLDinjectable, liposomal, injection266MG/20ML (13.3MG/ML)2 Jul 2044