FDA Orange Book
Generic for Xigduo XR
Xigduo XR contains dapagliflozin and metformin. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Xigduo XR is dapagliflozin and metformin. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Xigduo XR products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, extended release, oral | 10MG;1GM | Marketed (Rx) | AB | 8 | AB |
| tablet, extended release, oral | 10MG;500MG | Marketed (Rx) | AB | 8 | AB |
| tablet, extended release, oral | 2.5MG;1GM | Marketed (Rx) | AB | 1 | AB |
| tablet, extended release, oral | 5MG;1GM | Marketed (Rx) | AB | 8 | AB |
| tablet, extended release, oral | 5MG;500MG | Marketed (Rx) | AB | 7 | AB |
NDA 205649, held by ASTRAZENECA AB. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic dapagliflozin and metformin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ALKEM LABORATORIES LTD | 211563 | AB (A-rated, therapeutically equivalent) | April 6, 2026 | 10MG;1GM, 10MG;500MG, 5MG;1GM, 5MG;500MG |
| AUROBINDO PHARMA LTD | 211489 | AB (A-rated, therapeutically equivalent) | April 6, 2026 | 10MG;1GM, 10MG;500MG, 5MG;1GM, 5MG;500MG |
| LUPIN LTD | 211579 | AB (A-rated, therapeutically equivalent) | April 6, 2026 | 10MG;1GM, 10MG;500MG, 5MG;1GM, 5MG;500MG |
| MACLEODS PHARMACEUTICALS LTD | 211559 | AB (A-rated, therapeutically equivalent) | April 6, 2026 | 10MG;1GM, 10MG;500MG, 5MG;1GM, 5MG;500MG |
| MICRO LABS LTD | 211466 | AB (A-rated, therapeutically equivalent) | April 6, 2026 | 10MG;1GM, 10MG;500MG, 5MG;1GM, 5MG;500MG |
| MSN LABORATORIES PRIVATE LTD | 211479 | AB (A-rated, therapeutically equivalent) | April 6, 2026 | 10MG;1GM, 10MG;500MG, 5MG;1GM, 5MG;500MG |
| SUN PHARMACEUTICAL INDUSTRIES LTD | 211491 | AB (A-rated, therapeutically equivalent) | April 6, 2026 | 10MG;1GM, 10MG;500MG, 5MG;1GM |
| TEVA PHARMACEUTICALS USA INC | 211583 | AB (A-rated, therapeutically equivalent) | April 6, 2026 | 10MG;1GM, 10MG;500MG, 2.5MG;1GM, 5MG;1GM, 5MG;500MG |
Xigduo XR patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 6515117 | October 4, 2025 | Drug substance, Drug product | U-493 | 205649 |
| 6515117*PED | April 4, 2026 | Method of use | None | 205649 |
| 8501698 | June 20, 2027 | Drug product | U-493 | 205649 |
| 8501698*PED | December 20, 2027 | Method of use | None | 205649 |
| 7919598 | December 16, 2029 | Drug substance | None | 205649 |
| 8685934 | May 26, 2030 | Method of use | U-1522 | 205649 |
| 7919598*PED | June 16, 2030 | Method of use | None | 205649 |
| 9616028 | November 12, 2030 | Drug product | None | 205649 |
| 8685934*PED | November 26, 2030 | Method of use | None | 205649 |
| 9616028*PED | May 12, 2031 | Method of use | None | 205649 |
Xigduo XR exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NPP | New patient population | June 12, 2027 | 205649 |
| PED | Pediatric exclusivity | December 12, 2027 | 205649 |
Xigduo XR NDC codes
Questions
Is there a generic for Xigduo XR?
Yes. The generic name for Xigduo XR is dapagliflozin and metformin. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Xigduo XR?
The active ingredient in Xigduo XR is dapagliflozin and metformin, per the FDA Orange Book.
When does the Xigduo XR patent expire?
The last patent listed for Xigduo XR in the Orange Book expires May 12, 2031. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.