dapagliflozin; saxagliptin hydrochloride · Astrazeneca Ab · NDA 209091
Qtern
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 7919598 (pediatric extension).
FDA has approved 2 generic applications (ANDAs) for Qtern, though its earliest generic-entry date is 16 Jun 2030 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
14 Orange Book listing rows for 5 patents, including 5 pediatric extensions. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 7919598 | drug substance | 16 Jun 2030 |
| US 7919598 listing row | drug substance | 16 Dec 2029 |
| US 7919598 listing row | pediatric extension · sets the listed date | 16 Jun 2030 |
| US 8221786 | drug product | 21 Sep 2028 |
| US 8221786 listing row | drug product | 21 Mar 2028 |
| US 8221786 listing row | pediatric extension | 21 Sep 2028 |
| US 8361972 | use U-1976, U-1977, U-493 | 21 Sep 2028 |
| US 8361972 listing row | use U-1976 | 21 Mar 2028 |
| US 8361972 listing row | use U-1977 | 21 Mar 2028 |
| US 8361972 listing row | use U-493 | 21 Mar 2028 |
| US 8361972 listing row | pediatric extension | 21 Sep 2028 |
| US 8716251 | drug product | 21 Sep 2028 |
| US 8716251 listing row | drug product | 21 Mar 2028 |
| US 8716251 listing row | pediatric extension | 21 Sep 2028 |
| US 8501698 | drug product, use U-1976, U-1977, U-493 | 20 Dec 2027 |
| US 8501698 listing row | drug product, use U-1976 | 20 Jun 2027 |
| US 8501698 listing row | drug product, use U-1977 | 20 Jun 2027 |
| US 8501698 listing row | drug product, use U-493 | 20 Jun 2027 |
| US 8501698 listing row | pediatric extension | 20 Dec 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
- 25 Oct 2026First generic approved · 209091-0016 Apr 2026
- 25 Oct 2026Generic approved · 209091-0016 Apr 2026
- 25 Oct 2026First generic approved · 209091-0016 Apr 2026
- 25 Oct 2026Generic approved · 209091-0016 Apr 2026
Products covered · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 209091 · 001 · RLD · discontinued | tablet, oral | 10MG;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 16 Jun 2030 |
| 209091 · 002 · RLD · discontinued | tablet, oral | 5MG;EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 16 Jun 2030 |
Expired or delisted (2)
- US 6515117 · — · 4 Apr 2026
- US 6515117 · substance, product, use U-493 · 4 Oct 2025