lisinopril · Azurity · NDA 208401
Qbrelis
Blocked by patent: US 10039800, US 10265370, US 10406199, US 10940177, US 11179434, US 11771733, US 12128083, US 12186360, US 12433931, US 9463183, US 9616096, US 9814751.
FDA has approved 1 generic application (ANDA) for Qbrelis, though its earliest generic-entry date is 6 Nov 2035 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 · 12 unexpired
32 Orange Book listing rows for 12 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 10039800 | use U-1723, U-185, U-1864, U-1991, U-3, U-71, U-8 | 6 Nov 2035 |
| US 10039800 listing row | use U-1723 · sets the listed date | 6 Nov 2035 |
| US 10039800 listing row | use U-185 · sets the listed date | 6 Nov 2035 |
| US 10039800 listing row | use U-1864 · sets the listed date | 6 Nov 2035 |
| US 10039800 listing row | use U-1991 · sets the listed date | 6 Nov 2035 |
| US 10039800 listing row | use U-3 · sets the listed date | 6 Nov 2035 |
| US 10039800 listing row | use U-71 · sets the listed date | 6 Nov 2035 |
| US 10039800 listing row | use U-8 · sets the listed date | 6 Nov 2035 |
| US 10265370 | drug product · sets the listed date | 6 Nov 2035 |
| US 10406199 | use U-1723, U-185, U-1864, U-1991, U-3, U-71, U-8 | 6 Nov 2035 |
| US 10406199 listing row | use U-1723 · sets the listed date | 6 Nov 2035 |
| US 10406199 listing row | use U-185 · sets the listed date | 6 Nov 2035 |
| US 10406199 listing row | use U-1864 · sets the listed date | 6 Nov 2035 |
| US 10406199 listing row | use U-1991 · sets the listed date | 6 Nov 2035 |
| US 10406199 listing row | use U-3 · sets the listed date | 6 Nov 2035 |
| US 10406199 listing row | use U-71 · sets the listed date | 6 Nov 2035 |
| US 10406199 listing row | use U-8 · sets the listed date | 6 Nov 2035 |
| US 10940177 | drug product · sets the listed date | 6 Nov 2035 |
| US 11179434 | drug product · sets the listed date | 6 Nov 2035 |
| US 11771733 | drug product · sets the listed date | 6 Nov 2035 |
| US 12128083 | drug product · sets the listed date | 6 Nov 2035 |
| US 12186360 | drug product · sets the listed date | 6 Nov 2035 |
| US 12433931 | use U-1723, U-1864, U-3 | 6 Nov 2035 |
| US 12433931 listing row | use U-1723 · sets the listed date | 6 Nov 2035 |
| US 12433931 listing row | use U-1864 · sets the listed date | 6 Nov 2035 |
| US 12433931 listing row | use U-3 · sets the listed date | 6 Nov 2035 |
| US 9463183 | drug product · sets the listed date | 6 Nov 2035 |
| US 9616096 | use U-1723, U-185, U-1864, U-1991, U-3, U-71, U-8 | 6 Nov 2035 |
| US 9616096 listing row | use U-1723 · sets the listed date | 6 Nov 2035 |
| US 9616096 listing row | use U-185 · sets the listed date | 6 Nov 2035 |
| US 9616096 listing row | use U-1864 · sets the listed date | 6 Nov 2035 |
| US 9616096 listing row | use U-1991 · sets the listed date | 6 Nov 2035 |
| US 9616096 listing row | use U-3 · sets the listed date | 6 Nov 2035 |
| US 9616096 listing row | use U-71 · sets the listed date | 6 Nov 2035 |
| US 9616096 listing row | use U-8 · sets the listed date | 6 Nov 2035 |
| US 9814751 | drug product · sets the listed date | 6 Nov 2035 |
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 218419, Annora Pharma · 208401-001Approved 20 Aug 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 218419, Annora Pharma · 208401-001Approved 20 Aug 2026Detected 25 Oct 2026Historical import
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 208401 · 001 · RLD | solution, oral | 1MG/ML | 6 Nov 2035 |