balsalazide disodium · Valeant Pharms Intl · NDA 020610

Colazal

Earliest generic entry, as listed
24 Feb 2027

Blocked by patent: US 7452872 (pediatric extension), US 7625884 (pediatric extension).

Listed patents · 2 unexpired

PatentClaimsExpires
US 7452872pediatric extension · sets the listed date24 Feb 2027
US 7625884pediatric extension · sets the listed date24 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 · 020610-001Listed date 24 Feb 2027Detected 24 Oct 2026

Products covered · 1

NDA · productFormStrengthListed expiry
020610 · 001 · RLDcapsule, oral750MG24 Feb 2027
Expired or delisted (2)
  • US 7452872 · use U-141 · 24 Aug 2026
  • US 7625884 · use U-141 · 24 Aug 2026