Drug

Canagliflozin anhydrous

As of the edition of 20 October 2026, Canagliflozin anhydrous is a small molecule: marketed, first approved in 2013 (US); acts on SLC5A2; US protection ends in 2029.

Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.

The drug

Status
Marketed; latest approval 2014
Kind
Small molecule
Brand name
Invokana
First approved
29 March 2013 (US)
Approvals on record
24 in 6 regions
Holder of the most recent approval
Mitsubishi Tanabe Pharma; 5 holders in all
Registered trials
139, 2 stopped early
Disease areas
Nutrition and metabolism; Hormones; Urinary and reproductive; Pregnancy and women's health; Heart and blood vessels; Cancer

US protection

US protection ends in 2029.

The last listed US drug-substance patent ends in 2029. The application that gives this date is held by Johnson & Johnson.

This is the US only, and it is not the date generics or biosimilars can enter.

The exact date and the listings behind it

In the product

90 listings count towards this date. The exact date and each listing are in the product.

See the exact date and the 90 listings behind itRequest access. Nothing is shown until you do.

Companies that need a new molecule because of this drug

2 companies on route B because of this drug.

Companies on route B for this drug

In the product

2 companies are on route B because of Canagliflozin anhydrous.

Target

GeneProteinUniProt
SLC5A2Sodium/glucose cotransporter 2P31639

Registered trials

PhaseTrialsCompletedActiveStopped early
Phase not stated19631
Phase 1565330
Phase 212830
Phase 3252300
Phase 4271661
All trials139

Who has held its approvals

CompanyRoleYears
Johnson & JohnsonOriginator, Applicant and Lead sponsor of trials2006 to now
Mitsubishi Tanabe PharmaApplicant2014 to now