FDA Orange Book · active-ingredient family
Dapagliflozin; metformin hydrochloride
Dapagliflozin; metformin hydrochloride is approved as 1 brand and 10 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
1
Brand (NDA)
10
Generics (ANDA)
10
Listed patents
21
Exclusivity periods
Brand (NDA) products · tablet, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| XIGDUO XRRLD×5 | ASTRAZENECA AB | NDA 205649 | AB | Jul 28, 2017 |
Generic (ANDA) products (10)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE×4 | ALKEM LABS LTD | ANDA 211563 | AB | Apr 06, 2026 | |
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE×4 | AUROBINDO PHARMA | ANDA 211489 | AB | Apr 06, 2026 | |
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE | CIPLA | ANDA 211595 | AB | Apr 06, 2026 | |
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE×3 | CIPLA LTD | ANDA 211536 | AB | Apr 06, 2026 | |
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE×4 | LUPIN | ANDA 211579 | AB | Apr 06, 2026 | |
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE×4 | MACLEODS PHARMS LTD | ANDA 211559 | AB | Apr 06, 2026 | |
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE×4 | MICRO LABS | ANDA 211466 | AB | Apr 06, 2026 | |
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE×4 | MSN | ANDA 211479 | AB | Apr 06, 2026 | |
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE×3 | SUN PHARM | ANDA 211491 | AB | Apr 06, 2026 | |
| DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE×5 | TEVA PHARMS USA INC | ANDA 211583 | AB | Apr 06, 2026 |
Marketing exclusivity (21)
- PCPatent-challenge (180-day generic) exclusivity
Oct 03, 2026
in 4 mo
- PCPatent-challenge (180-day generic) exclusivity
Oct 03, 2026
in 4 mo
- PCPatent-challenge (180-day generic) exclusivity
Oct 03, 2026
in 4 mo
- PCPatent-challenge (180-day generic) exclusivity
Oct 03, 2026
in 4 mo
- PCPatent-challenge (180-day generic) exclusivity
Oct 03, 2026
in 4 mo
- PCPatent-challenge (180-day generic) exclusivity
Oct 03, 2026
in 4 mo
- PCPatent-challenge (180-day generic) exclusivity
Oct 03, 2026
in 4 mo
- PCPatent-challenge (180-day generic) exclusivity
Oct 03, 2026
in 4 mo
- PCPatent-challenge (180-day generic) exclusivity
Oct 03, 2026
in 4 mo
- PCPatent-challenge (180-day generic) exclusivity
Oct 03, 2026
in 4 mo
- PCPatent-challenge (180-day generic) exclusivity
Oct 03, 2026
in 4 mo
- NPPNew patient population exclusivity (3 years)
Jun 12, 2027
in 1 yr
- PEDPediatric exclusivity (adds 6 months)
Dec 12, 2027
in 1 yr 6 mo
- NPPNew patient population exclusivity (3 years)
Jun 12, 2027
in 1 yr
- PEDPediatric exclusivity (adds 6 months)
Dec 12, 2027
in 1 yr 6 mo
- NPPNew patient population exclusivity (3 years)
Jun 12, 2027
in 1 yr
- PEDPediatric exclusivity (adds 6 months)
Dec 12, 2027
in 1 yr 6 mo
- NPPNew patient population exclusivity (3 years)
Jun 12, 2027
in 1 yr
- PEDPediatric exclusivity (adds 6 months)
Dec 12, 2027
in 1 yr 6 mo
- NPPNew patient population exclusivity (3 years)
Jun 12, 2027
in 1 yr
- PEDPediatric exclusivity (adds 6 months)
Dec 12, 2027
in 1 yr 6 mo
Listed patents (10)
| Patent | Expires | In | Type |
|---|---|---|---|
| 6515117 | Oct 04, 2025 | 9 mo ago | SubstanceProductU-493 |
| 6515117*PED | Apr 04, 2026 | 3 mo ago | |
| 8501698 | Jun 20, 2027 | in 1 yr | ProductU-493 |
| 8501698*PED | Dec 20, 2027 | in 1 yr 6 mo | |
| 7919598 | Dec 16, 2029 | in 3 yr 7 mo | Substance |
| 8685934 | May 26, 2030 | in 4 yr | U-1522 |
| 7919598*PED | Jun 16, 2030 | in 4 yr 1 mo | |
| 9616028 | Nov 12, 2030 | in 4 yr 6 mo | Product |
| 8685934*PED | Nov 26, 2030 | in 4 yr 6 mo | |
| 9616028*PED | May 12, 2031 | in 5 yr |
Dapagliflozin; metformin hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
