topiramate · Upsher Smith Labs · NDA 205122
Qudexy Xr
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
| Patent | Claims | Expires |
|---|---|---|
| US 10363224 | use U-766 · sets the listed date | 19 Mar 2033 |
| US 8652527 | drug product · sets the listed date | 19 Mar 2033 |
| US 8889190 | drug product · sets the listed date | 19 Mar 2033 |
| US 9101545 | drug product · sets the listed date | 19 Mar 2033 |
| US 9555005 | drug product · sets the listed date | 19 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
- Generic approved · ANDA 220041, Riconpharma Llc · 205122-001Approved 26 May 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 220943, Biocon Pharma · 205122-001Approved 22 Jul 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 217443, Ascent Pharms Inc · 205122-001Approved 12 Jan 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 219183, Micro Labs · 205122-001Approved 4 Sep 2026Detected 25 Oct 2026Historical import
Products covered · 5
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 205122 · 001 · RLD | capsule, extended release, oral | 25MG | 19 Mar 2033 |
| 205122 · 002 · RLD | capsule, extended release, oral | 50MG | 19 Mar 2033 |
| 205122 · 003 · RLD | capsule, extended release, oral | 100MG | 19 Mar 2033 |
| 205122 · 004 · RLD | capsule, extended release, oral | 150MG | 19 Mar 2033 |
| 205122 · 005 · RLD | capsule, extended release, oral | 200MG | 19 Mar 2033 |