levomilnacipran hydrochloride · Abbvie · NDA 204168

Fetzima

Earliest generic entry, as listed · earliest of 4 marketed strengths
23 May 2032

Blocked by patent: US 8865937.

Listed patents · 2 unexpired

PatentClaimsExpires
US 8865937substance, product23 May 2032
US 8481598use U-8392 Mar 2031

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

No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.

Products covered · 4

NDA · productFormStrengthListed expiry
204168 · 001 · RLDcapsule, extended release, oralEQ 20MG BASE23 May 2032
204168 · 002 · RLDcapsule, extended release, oralEQ 40MG BASE23 May 2032
204168 · 003 · RLDcapsule, extended release, oralEQ 80MG BASE23 May 2032
204168 · 004 · RLDcapsule, extended release, oralEQ 120MG BASE23 May 2032
Expired or delisted (2)
  • US RE43879 · use U-839 · 11 Jan 2026
  • M-304 · 24 Mar 2026