Dapagliflozin
As of the edition of 20 October 2026, Dapagliflozin is a small molecule: marketed, first approved in 2012 (EU); 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 2017
- Kind
- Small molecule
- Brand name
- Farxiga
- First approved
- 11 November 2012 (EU)
- Approvals on record
- 33 in 6 regions
- Holder of the most recent approval
- AstraZeneca; 3 holders in all
- Registered trials
- 443, 27 stopped early
- Disease areas
- Nutrition and metabolism; Hormones; Heart and blood vessels; Urinary and reproductive; Pregnancy and women's health; Immune system
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 AstraZeneca.
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 product46 listings count towards this date. The exact date and each listing are in the product.
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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 product2 companies are on route B because of Dapagliflozin.
See the 2 companies on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| SLC5A2 | Sodium/glucose cotransporter 2 | P31639 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 61 | 25 | 18 | 1 |
| Phase 1 | 62 | 46 | 9 | 3 |
| Phase 2 | 75 | 30 | 26 | 9 |
| Phase 3 | 122 | 65 | 41 | 4 |
| Phase 4 | 123 | 59 | 22 | 10 |
| All trials | 443 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| AstraZeneca | Applicant, Later holder and Lead sponsor of trials | 2005 to now |
| Bristol Myers Squibb | Applicant | 2014 to now |