cliffwatch

topiramate · Upsher Smith Labs · NDA 205122

Qudexy Xr

Earliest generic entry, as listed · earliest of 5 marketed strengths
19 Mar 2033

Blocked by patent: US 10363224, US 8652527, US 8889190, US 9101545, US 9555005.

FDA has approved 4 generic applications (ANDAs) for Qudexy Xr, though its earliest generic-entry date is 19 Mar 2033 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 · 5 unexpired

PatentClaimsExpires
US 10363224use U-76619 Mar 2033
US 8652527product19 Mar 2033
US 8889190product19 Mar 2033
US 9101545product19 Mar 2033
US 9555005product19 Mar 2033

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

  • 25 Oct 2026Generic approved · 205122-001
  • 25 Oct 2026Generic approved · 205122-001
  • 25 Oct 2026Generic approved · 205122-001
  • 25 Oct 2026Generic approved · 205122-001

Products covered · 5

NDA · productFormStrengthListed expiry
205122 · 001 · RLDcapsule, extended release, oral25MG19 Mar 2033
205122 · 002 · RLDcapsule, extended release, oral50MG19 Mar 2033
205122 · 003 · RLDcapsule, extended release, oral100MG19 Mar 2033
205122 · 004 · RLDcapsule, extended release, oral150MG19 Mar 2033
205122 · 005 · RLDcapsule, extended release, oral200MG19 Mar 2033