dapagliflozin; metformin hydrochloride; saxagliptin hydrochloride · Astrazeneca Ab · NDA 210874
Qternmet Xr
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 9616028 (pediatric extension).
Listed patents · 4 unexpired
8 Orange Book listing rows for 4 patents, including 4 pediatric extensions. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 9616028 | drug product | 12 May 2031 |
| US 9616028 listing row | drug product | 12 Nov 2030 |
| US 9616028 listing row | pediatric extension · sets the listed date | 12 May 2031 |
| US 7919598 | drug substance | 16 Jun 2030 |
| US 7919598 listing row | drug substance | 16 Dec 2029 |
| US 7919598 listing row | pediatric extension | 16 Jun 2030 |
| 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-493 | 20 Dec 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
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 4
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 210874 · 001 · RLD · discontinued | tablet, extended release, oral | 2.5MG;1GM;EQ 2.5MG BASE | 12 May 2031 |
| 210874 · 002 · RLD · discontinued | tablet, extended release, oral | 5MG;1GM;EQ 2.5MG BASE | 12 May 2031 |
| 210874 · 003 · RLD · discontinued | tablet, extended release, oral | 5MG;1GM;EQ 5MG BASE | 12 May 2031 |
| 210874 · 004 · RLD · discontinued | tablet, extended release, oral | 10MG;1GM;EQ 5MG BASE | 12 May 2031 |
Expired or delisted (2)
- US 6515117 · — · 4 Apr 2026
- US 6515117 · substance, product, use U-493 · 4 Oct 2025