ERTUGLIFLOZIN | N209803 | MERCK SHARP AND DOHME LLC A SUB OF MERCK AND CO INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Merck Sharp & Dohme Corp. et al v. Hetero Labs Limited et al 1 patentANDA 217071ertugliflozin | D. Del. | 2022-03-23 | Terminated 2023-05-18 | — |
| D. Del. | 2022-03-23 | Terminated 2023-05-18 | — | |
| D. Del. | 2022-03-23 | Terminated 2023-05-18 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
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
$11.44
per ea
Lowest NADAC/Unit
$11.43
per ea
Brand NDCs
4
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00006536403STEGLATRO 15 MG TABLET | $11.44 | EA | Brand | — | 2026-06-17 |
| 00006536406STEGLATRO 15 MG TABLET | $11.44 | EA | Brand | — | 2026-06-17 |
| 00006536303STEGLATRO 5 MG TABLET | $11.43 | EA | Brand | — | 2026-06-17 |
| 00006536306STEGLATRO 5 MG TABLET | $11.43 | EA | Brand | — | 2026-06-17 |
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 |
|---|---|---|---|---|---|---|
| 8080580 | Dec 19, 2031 | — | Yes | Yes | — |