dapagliflozin; metformin hydrochloride · Astrazeneca Ab · NDA 205649
Xigduo Xr
Earliest generic entry, as listed · earliest of 5 marketed strengths
12 May 2031
Blocked by patent: US 9616028.
Listed patents · 8 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 9616028 | — | 12 May 2031 |
| US 8685934 | — | 26 Nov 2030 |
| US 9616028 | product | 12 Nov 2030 |
| US 7919598 | — | 16 Jun 2030 |
| US 8685934 | use U-1522 | 26 May 2030 |
| US 7919598 | substance | 16 Dec 2029 |
| US 8501698 | — | 20 Dec 2027 |
| US 8501698 | product, use U-493 | 20 Jun 2027 |
Exclusivities · 2 unexpired
| PED | pediatric (6 months added) | 12 Dec 2027 |
| NPP | new patient population | 12 Jun 2027 |
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 · 205649-0016 Apr 2026
- 25 Oct 2026Generic approved · 205649-0016 Apr 2026
- 25 Oct 2026First generic approved · 205649-0016 Apr 2026
- 25 Oct 2026Generic approved · 205649-0016 Apr 2026
- 25 Oct 2026Generic tentatively approved · 205649-0016 Apr 2026
- 25 Oct 2026First generic approved · 205649-0016 Apr 2026
- 25 Oct 2026Generic approved · 205649-0016 Apr 2026
- 25 Oct 2026First generic approved · 205649-0016 Apr 2026
- 25 Oct 2026Generic approved · 205649-0016 Apr 2026
- 25 Oct 2026First generic approved · 205649-0016 Apr 2026
- 25 Oct 2026Generic approved · 205649-0016 Apr 2026
- 25 Oct 2026Generic tentatively approved · 205649-0016 Apr 2026
- 25 Oct 2026First generic approved · 205649-0016 Apr 2026
- 25 Oct 2026Generic approved · 205649-0016 Apr 2026
- 25 Oct 2026Generic tentatively approved · 205649-0016 Apr 2026
Products covered · 5
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 205649 · 001 · RLD | tablet, extended release, oral | 5MG;500MG | 12 May 2031 |
| 205649 · 002 · RLD | tablet, extended release, oral | 5MG;1GM | 12 May 2031 |
| 205649 · 003 · RLD | tablet, extended release, oral | 10MG;500MG | 12 May 2031 |
| 205649 · 004 · RLD | tablet, extended release, oral | 10MG;1GM | 12 May 2031 |
| 205649 · 005 · RLD | tablet, extended release, oral | 2.5MG;1GM | 12 May 2031 |
Expired or delisted (2)
- US 6515117 · — · 4 Apr 2026
- US 6515117 · substance, product, use U-493 · 4 Oct 2025