cliffwatch

bupropion hydrochloride · Twi Pharms · NDA 022497

Forfivo Xl

Earliest generic entry, as listed
23 Aug 2028

Blocked by patent: US 7674479.

FDA has approved 4 generic applications (ANDAs) for Forfivo Xl, though its earliest generic-entry date is 23 Aug 2028 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 · 1 unexpired

PatentClaimsExpires
US 7674479product23 Aug 2028

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 · 022497-001
  • 25 Oct 2026Generic approved · 022497-001
  • 25 Oct 2026Generic approved · 022497-001
  • 25 Oct 2026Generic approved · 022497-001

Products covered · 1

NDA · productFormStrengthListed expiry
022497 · 001 · RLDtablet, extended release, oral450MG23 Aug 2028