NDAORALTABLET
Approved
Aug 2014
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
2
Mechanism of Action
SGLT2, expressed in the proximal renal tubules, is responsible for the majority of the reabsorption of filtered glucose from the tubular lumen. Canagliflozin is an inhibitor of SGLT2. By inhibiting SGLT2, canagliflozin reduces reabsorption of filtered glucose and lowers the renal threshold for…
Indications (8)
established cardiovascular disease ( )nonfatal myocardial infarctionnonfatal stroke) in adults with type 2 diabetes mellitusestablished cardiovascular disease (CVD)type 2 diabetes mellitus to reduce the risk of: Major adverse cardiovascular events in adults with type 2 diabetes mellitustype 2 diabetes mellitus to reduce the risk of: Major adverse cardiovascular events (cardiovascular deathtype 2 diabetes mellitustype 1 diabetes mellitus
Clinical Trials (2)
A Study to Assess Safety of Canagliflozin and Metformin Hydrochloride Combination Given as a Supplement to Diet and Exercise to Improve Blood Sugar Level in Indian Adult Participants With Diabetes
Started Nov 2020
276 enrolled
Diabetes Mellitus
A Study to Assess the Pharmacokinetics and Pharmacodynamics of Canagliflozin (JNJ-28431754) in Healthy Indian Volunteers
Started Aug 2008
16 enrolled
Healthy
Loss of Exclusivity
LOE Date
Jul 6, 2030
52 months away
Patent Expiry
Jul 6, 2030
Exclusivity Expiry
Jun 18, 2028
Patent Records (5)
| Patent # | Expiry | Type | Use Code |
|---|---|---|---|
| 7943788 | Jul 14, 2027 | SubstanceProduct | — |
| 8513202 | Dec 3, 2027 | SubstanceProduct | U-2441 |
| 7943788*PED | Jan 14, 2028 | — | |
| 8513202*PED | Jun 3, 2028 | — | |
| 7943582 | Feb 26, 2029 | SubstanceProduct | U-2441 |