cliffwatch

pomalidomide · Bristol · NDA 204026

Pomalyst

Earliest generic entry, as listed · earliest of 4 marketed strengths
21 Dec 2031

Blocked by patent: US 8828427 (pediatric extension).

FDA has approved 5 generic applications (ANDAs) for Pomalyst, though its earliest generic-entry date is 21 Dec 2031 as listed. A generic can be approved before that date when it leaves out a patented use (a section viii carve-out), challenges a patent, or settles with the brand company. An approval is not a launch: cliffwatch does not track launches. Approval is not launch

Listed patents · 3 unexpired

6 Orange Book listing rows for 3 patents, including 3 pediatric extensions. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.

PatentClaimsExpires
US 8828427drug substance, drug product21 Dec 2031
US 8828427 listing rowdrug substance, drug product21 Jun 2031
US 8828427 listing rowpediatric extension · sets the listed date21 Dec 2031
US 10555939drug product19 Nov 2030
US 10555939 listing rowdrug product19 May 2030
US 10555939 listing rowpediatric extension19 Nov 2030
US 9993467drug product19 Nov 2030
US 9993467 listing rowdrug product19 May 2030
US 9993467 listing rowpediatric extension19 Nov 2030

Exclusivities · 3 unexpired

PEDpediatric (6 months added)14 Nov 2027
ODE-296orphan drug (7 years)14 May 2027
ODE-297orphan drug (7 years)14 May 2027

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

  • 25 Oct 2026Generic approved · 204026-001
  • 25 Oct 2026Generic approved · 204026-001
  • 25 Oct 2026Generic approved · 204026-001
  • 25 Oct 2026Generic approved · 204026-001
  • 25 Oct 2026Generic approved · 204026-001

Products covered · 4

NDA · productFormStrengthListed expiry
204026 · 001 · RLDcapsule, oral1MG21 Dec 2031
204026 · 002 · RLDcapsule, oral2MG21 Dec 2031
204026 · 003 · RLDcapsule, oral3MG21 Dec 2031
204026 · 004 · RLDcapsule, oral4MG21 Dec 2031