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 Hyman, Phelps & McNamara, P.C. FDA-2026-P-4020 The law firm Hyman, Phelps & McNamara, P.C., submitted this suitability petition on behalf of a client under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that FDA declare Dapagliflozin Chewable Tablets in 5 mg and 10 mg strengths suitable for submission as an Abbreviate | Suitability | 2026-04-13 | Open | Hyman |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| 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 | Nov 8, 2026 | < 1 year |