CANAGLIFLOZIN | N204042 | JANSSEN PHARMACEUTICALS INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
MITSUBISHI TANABE PHARMA CORPORATION et al v. MSN LABORATORIES PRIVATE LTD. et al 1 patentANDA 210462, 213403canagliflozin | D.N.J. | 2019-10-14 | Terminated 2020-02-26 | — |
MITSUBISHI TANABE PHARMA CORPORATION et al v. AUROBINDO PHARMA USA INC. 2 patentsANDA 210386canagliflozin | D.N.J. | 2017-11-27 | Terminated 2021-03-24 | — |
| D. Del. | 2017-07-21 | Terminated 2017-12-18 | — | |
Mitsubishi Tanabe Pharma Corporation et al v. Sandoz, Inc. 2 patentsANDA 210297, 210481canagliflozin | D. Colo. | 2017-07-21 | Terminated 2017-10-10 | — |
Mitsubishi Tanabe Pharma Corporation et al v. Sandoz Inc. 1 patentANDA 210297, 210481canagliflozin | D. Colo. | 2017-07-21 | Terminated 2017-10-09 | — |
MITSUBISHI TANABE PHARMA CORPORATION et al v. SANDOZ INC. et al 3 patentsANDA 210297, 210481, 210541, 210542canagliflozin and canagliflozin and metformin hydrochloride | D.N.J. | 2017-07-20 | Terminated 2021-04-05 | — |
| D. Del. | 2017-07-20 | Terminated 2017-12-21 | — | |
MITSUBISHI TANABE PHARMA CORPORATION et al v. PRINSTON PHARMACEUTICAL, INC. et al 2 patentsANDA 210514, 210502, 210477canagliflozin; canagliflozin and metformin hydrochloride | D.N.J. | 2017-07-13 | Terminated 2019-06-19 | — |
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
$19.13
per ea
Lowest NADAC/Unit
$19.10
per ea
Brand NDCs
4
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 50458014130INVOKANA 300 MG TABLET | $19.13 | EA | Brand | — | 2026-06-17 |
| 50458014190INVOKANA 300 MG TABLET | $19.13 | EA | Brand | — | 2026-06-17 |
| 50458014030INVOKANA 100 MG TABLET | $19.10 | EA | Brand | — | 2026-06-17 |
| 50458014090INVOKANA 100 MG TABLET | $19.10 | EA | Brand | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
| Code | Date | Status |
|---|---|---|
| NPP | Dec 18, 2027 | Active |
| PED | Jun 18, 2028 | Active |
| NPP*PEDNewly listed — daily FDA feed, not yet in monthly Orange Book edition | Jun 18, 2028 | Active |
Janssen Pharmaceuticals' INVOKANA (canagliflozin) NDA 204042 received pediatric exclusivity, extending regulatory exclusivity to Jun 2028.
New: INVOKANA (CANAGLIFLOZIN) — exclusivity NPP*PED exp 06/18/2028
INVOKANA (canagliflozin) gains pediatric exclusivity expiring Jun 2028, extending regulatory exclusivity protection for the NDA.
New: INVOKANA (CANAGLIFLOZIN) — exclusivity NPP*PED exp 06/18/2028