tramadol hydrochloride · Rosemount · NDA 214044
Qdolo
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 11103452, US 11752103.
FDA has approved 1 generic application (ANDA) for Qdolo, though its earliest generic-entry date is 1 Sep 2040 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 · 2 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11103452 | drug product, use U-3197 · sets the listed date | 1 Sep 2040 |
| US 11752103 | drug product, use U-3197 · sets the listed date | 1 Sep 2040 |
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
- First generic approved · ANDA 219647, Novitium Pharma · 214044-001Approved 26 Jun 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 219647, Novitium Pharma · 214044-001Approved 26 Jun 2026Detected 25 Oct 2026Historical import
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 214044 · 001 · RLD · discontinued | solution, oral | 5MG/ML | 1 Sep 2040 |