DAPAGLIFLOZIN | N202293 | ASTRAZENECA AB
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
AstraZeneca AB v. Sun Pharmaceutical Industries Limited et al 1 patentANDA 211416dapagliflozin | D. Del. | 2023-12-04 | Active | — |
| D. Del. | 2018-05-01 | Terminated 2022-07-28 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Senores Pharmaceuticals, Inc FDA-2026-P-7623 · 5 docket documents Senores Pharmaceuticals, Inc. filed a suitability petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting FDA determination that Dapagliflozin Tablets 7.5 mg is suitable for submission in an Abbreviated New Drug Application. The proposed product would be bioequival | Suitability | 2026-07-09 | Open | Senores Pharmaceuticals, Inc |
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2026-P-4020 · 6 docket documents Law firm Hyman, Phelps & McNamara filed this suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Dapagliflozin Chewable Tablets in 5 mg and 10 mg strengths suitable for submission as an ANDA, with the reference listed drug being | Suitability | 2026-04-13 | Open | Hyman, Phelps & McNamara, P.C. |
Citizen Petition from Lem Moye FDA-2022-P-2708 · 4 docket documents Lem Moyé, M.D., Ph.D. filed this petition on November 1, 2022, requesting that the FDA reexamine the DECLARE clinical trial results regarding dapagliflozin, specifically challenging the construction of the combined endpoint of cardiovascular death and hospitalization for heart failure, and asking th | 505(q) | 2022-11-01 | Denied | Lem Moye |
Citizen Petition from Public Citizen's Health Research Group FDA-2020-P-1611 · 17 docket documents Public Citizen's Health Research Group filed this petition under Sections 502 and 505(o)(4) of the FDCA requesting that the FDA immediately add boxed warnings to all sodium-glucose cotransporter-2 inhibitor drugs (canagliflozin, dapagliflozin, empagliflozin, and ertugliflozin) contraindicating their | Other | 2020-06-24 | Denied | Public Citizen's Health Research Group |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$12.08
per ea
Lowest NADAC/Unit
$0.1845
per ea
Brand NDCs
5
Generic NDCs
2
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00310621039FARXIGA 10 MG TABLET | $12.08 | EA | Brand | $0.2049 | 2026-06-17 |
| 00310621030FARXIGA 10 MG TABLET | $12.08 | EA | Brand | $0.2049 | 2026-06-17 |
| 00310621090FARXIGA 10 MG TABLET | $12.08 | EA | Brand | $0.2049 | 2026-06-17 |
| 00310620530FARXIGA 5 MG TABLET | $12.08 | EA | Brand | $0.1845 | 2026-06-17 |
| 00310620590FARXIGA 5 MG TABLET | $12.08 | EA | Brand | $0.1845 | 2026-06-17 |
| 66993045730DAPAGLIFLOZIN 10 MG TABLET | $0.2049 | EA | Generic | — | 2026-06-03 |
| 66993045630DAPAGLIFLOZIN 5 MG TABLET | $0.1845 | EA | Generic | — | 2026-06-03 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 6515117 | Oct 4, 2025PED: Apr 4, 2026 | PED | Yes | Yes | — | |
| 7851502 | Aug 19, 2028PED: Feb 19, 2029 | PED | — | Yes | — | — |
| 7919598 | Dec 16, 2029PED: Jun 16, 2030 | PED | Yes | — | — | — |
| 8221786 | Mar 21, 2028PED: Sep 21, 2028 | PED | — | Yes | — | — |
| 8329648 | Aug 18, 2026PED: Feb 18, 2027 | PED | — | — | — | |
| 8361972 | Mar 21, 2028PED: Sep 21, 2028 | PED | — | — | — | |
| 8501698 | Jun 20, 2027PED: Dec 20, 2027 | PED | — | Yes | — | |
| 8685934 | May 26, 2030PED: Nov 26, 2030 | PED | — | — | — | |
| 8716251 | Mar 21, 2028PED: Sep 21, 2028 | PED | — | Yes | — | — |
| 8721615 | Jan 18, 2030PED: Jul 18, 2030 | PED | — | Yes | — | Delisted |
| 8906851 | Aug 18, 2026PED: Feb 18, 2027 | PED | — | — | — |
| Code | Date | Status |
|---|---|---|
| M-298 | May 8, 2026 | Expired |
| NPP | Jun 12, 2027 | < 1 year |
| PED | Dec 12, 2027 | Active |
| PED | Nov 8, 2026 | < 1 year |