desvenlafaxine succinate · Pf Prism Cv · NDA 021992
Pristiq
Earliest generic entry, as listed · earliest of 3 marketed strengths
5 Jul 2027
Blocked by patent: US 8269040.
FDA has approved 1 generic application (ANDA) for Pristiq, though its earliest generic-entry date is 5 Jul 2027 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
| Patent | Claims | Expires |
|---|---|---|
| US 8269040 | drug substance · sets the listed date | 5 Jul 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
- Generic approved · ANDA 220460, Yichang Humanwell · 021992-001Approved 10 Mar 2026Detected 25 Oct 2026Historical import
- Enters 12-month window basis: patent · 021992-002Listed date 5 Jul 2027Detected 24 Oct 2026
- Enters 12-month window basis: patent · 021992-001Listed date 5 Jul 2027Detected 24 Oct 2026
- Enters 12-month window basis: patent · 021992-003Listed date 5 Jul 2027Detected 24 Oct 2026
Products covered · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 021992 · 001 · RLD | tablet, extended release, oral | EQ 50MG BASE | 5 Jul 2027 |
| 021992 · 002 · RLD | tablet, extended release, oral | EQ 100MG BASE | 5 Jul 2027 |
| 021992 · 003 · RLD | tablet, extended release, oral | EQ 25MG BASE | 5 Jul 2027 |