When does Farxiga go off patent?
It already has. Farxiga is sold by AstraZeneca. FDA approved the first US generics on 6 April 2026.
Farxiga's US exclusivity date is based on generics launched. US generics have already launched, so the loss of exclusivity is under way. It is a small-molecule drug, so copies are generics. Generic launches usually take most of the US volume within months.
| Patent or protection | Covers | Expiry |
|---|---|---|
| US 6,515,117 | Dapagliflozin itself, with pediatric exclusivity | 4 April 2026 |
| First US generics approved | 15 makers at once | 6 April 2026 |
| Later US patents | Formulations, crystal forms and uses, still listed with the FDA | 1 October 2041 |
| Europe patents | Forxiga; several face validity challenges | 2027 to 2041 |
| Japan patents | Forxiga | 2027 to 2041 |
| China patents | Forxiga | 2025 to 2040 |
Farxiga's US compound patent ran to April 2026 with pediatric exclusivity, and the FDA approved 15 generics at once on 6 April 2026. Later patents on formulations, crystal forms and uses stay listed with the FDA until 2041, but did not stop the launches. Outside the US, AstraZeneca lists patents expiring from 2027 in Europe, where several face validity challenges, from 2027 in Japan and from 2025 in China.
Sources: FDA Orange Book data files · AstraZeneca 20-F 2025 · FDA: first generics
| Year | Worldwide | US | Growth |
|---|---|---|---|
| 2023 | $5.96B | $1.45B | – |
| 2024 | $7.66B | $1.75B | +28% |
| 2025 | $8.40B | $1.73B | +10% |
2023 as restated in the 2025 20-F. 2025 is the last full year before US generics. Worldwide net sales as reported, with the US share. Source: AstraZeneca 20-F 2025
Copies on the US market The FDA approved 15 generic versions at once on 6 April 2026, ending US exclusivity.
180-day exclusivity: 20 generic applications were filed on the first day patents could be challenged (8 Jan 2018). The FDA found first filers eligible to share it, and it ran from first sales on 6 Apr 2026 to about 3 Oct 2026, so other approved generics can now launch. FDA Paragraph IV list (28 Sep 2026)
| Company (product) | Stage |
|---|---|
| Aizant | FDA-approved 6 Apr 2026 |
| Ajanta | FDA-approved 6 Apr 2026 |
| Alembic | FDA-approved 6 Apr 2026; said it was eligible for 180-day shared exclusivity, which ended about 3 Oct 2026 |
| Alkem | FDA-approved 6 Apr 2026 |
| Aurobindo | FDA-approved 6 Apr 2026; said it was eligible for 180-day shared exclusivity, which ended about 3 Oct 2026 |
| Biocon | FDA-approved 6 Apr 2026 |
| Cipla | FDA-approved 6 Apr 2026 |
| Inventia | FDA-approved 6 Apr 2026; first filer; its 180-day shared exclusivity ended about 3 Oct 2026 |
| Lupin | FDA-approved 6 Apr 2026; launched 10 Apr 2026 |
| Macleods | FDA-approved 6 Apr 2026 |
| Micro Labs | FDA-approved 6 Apr 2026 |
| MSN | FDA-approved 6 Apr 2026 |
| Sandoz | FDA-approved 6 Apr 2026 |
| Teva | FDA-approved 6 Apr 2026; launched Apr 2026 |
| Zydus | FDA-approved 6 Apr 2026; said it was eligible for 180-day shared exclusivity, which ended about 3 Oct 2026. Eligible for 180-day shared generic exclusivity |
Approval dates are from the FDA's own lists. A maker shows as launched only when its own release or filing confirms it; FDA-approved means a launch is not confirmed, not that the copy is off the market. Checked October 2026. Sources: FDA Orange Book data files · FDA: first generics · Teva 10-Q, Q2 2026 (launches) · Alembic approval (coverage) · Aurobindo approval (coverage) · FDA approval letter, ANDA 211156 · FDA Paragraph IV list (28 Sep 2026) · Lupin: dapagliflozin US launch · Zydus: dapagliflozin approval (NSE filing)
In Q2 2026, US sales were $219M, 49% of the $449M in Q1 2026, the last full quarter before copies.
The FDA approved 15 generics at once in April 2026; US sales halved in the first quarter.
| Quarter | US sales | vs Q1 2026 |
|---|---|---|
| Q3 2025 | $441M | 98% |
| Q4 2025 | $486M | 108% |
| Q1 2026 | $449M | 100% |
| Q2 2026 · copies launch | $219M | 49% |
Among past small-molecule drugs facing unrestricted generics, US sales in the first full year after copies arrived were a median 18% of the last full year before (range 0% to 48%, 10 drugs), and 6% by the third year (8 drugs). Where settlements limit generic volumes, as with Revlimid, the decline is slower. Every drug is different: settlements, how many copies launch, and pricing all change the curve. See the erosion benchmarks →
Farxiga was selected for the Medicare Drug Price Negotiation Program. Its negotiated Medicare price takes effect in 2026, 68% below its list price. That is the same year US generics can launch. The discount is measured against list price, before the rebates drugmakers already pay, and applies to Medicare only, so the revenue impact is smaller than the headline number. See every negotiated Medicare price →
Farxiga is 14% of AstraZeneca's 2025 revenue ($8.4B of $58.7B). With Lynparza, Imfinzi, Tagrisso, Calquence and Ultomiris, the drugs tracked here add up to 57% of AstraZeneca's revenue losing US exclusivity by 2035.
Bars show each company's tracked drugs as a share of its total 2025 revenue. Farxiga is highlighted.