1 January 2027
Medicare negotiated prices for Stelara, Entresto and Xarelto stop applying
CMS removes them from the program after generics or biosimilars reached the market; their prices applied in 2026 only.
When does Entresto go off patent?
It already has. Entresto is sold by Novartis. US generics entered in Q3 2025.
Entresto'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 exclusivity | Ended when generics launched | July 2025 |
| EU regulatory data protection | Entresto in Europe | November 2026 |
Novartis lost US exclusivity in July 2025, when MSN (through Novadoz) and Torrent launched generics. The FDA has approved 16 generic versions. US sales fell from about $1.2B a quarter to slightly below zero by Q2 2026, as returns and rebates outweighed new sales. In Europe, regulatory data protection ends in November 2026, and Novartis expects sales there to decline substantially unless its later patents hold.
Sources: Novartis 20-F 2025
| Year | Worldwide | US | Growth |
|---|---|---|---|
| 2023 | $6.04B | $3.07B | – |
| 2024 | $7.82B | $4.05B | +30% |
| 2025 | $7.75B | $3.29B | -1% |
Worldwide net sales as reported, with the US share. Source: Novartis 20-F 2025 and 2024
Copies on the US market The FDA has approved 16 generic versions. The first launched in July 2025 (MSN, through Novadoz), with Torrent two days later.
180-day exclusivity: 18 generic applications were filed on the first day patents could be challenged (8 Jul 2019), and a first filer began selling on 23 Jul 2025. The FDA has not decided whether exclusivity applies. FDA Paragraph IV list (28 Sep 2026)
| Company (product) | Stage |
|---|---|
| Alembic | FDA-approved 28 May 2024; first filer; FDA has not decided whether it keeps 180-day shared exclusivity |
| Crystal Pharmaceutical (Suzhou) | FDA-approved 28 May 2024; first filer; FDA has not decided whether it keeps 180-day shared exclusivity |
| Laurus Labs | FDA-approved 28 May 2024; first filer; FDA has not decided whether it keeps 180-day shared exclusivity |
| Zydus | FDA-approved 9 Jul 2024 |
| Torrent | FDA-approved 22 Aug 2024; launched Jul 2025 |
| Biocon | FDA-approved 30 Aug 2024 |
| Alkem | FDA-approved 16 Sep 2024 |
| Macleods | FDA-approved 16 Oct 2024 |
| Lupin | FDA-approved 8 Jan 2025 |
| Dr. Reddy's | FDA-approved 13 Jan 2025 |
| MSN | FDA-approved 16 Jul 2025; launched Jul 2025; first filer; FDA has not decided whether it keeps 180-day shared exclusivity. Sells through Novadoz; first US generic |
| Novugen | FDA-approved 16 Jul 2025 |
| Hetero | FDA-approved 17 Jul 2025 |
| Somerset Therapeutics | FDA-approved 20 Jan 2026 |
| Umedica | FDA-approved 4 Aug 2026 |
| Aurobindo | FDA-approved 2 Sep 2026 |
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 · Optum Rx: first launches · FDA approval letter, ANDA 213682 · FDA Paragraph IV list (28 Sep 2026) · FDA approval letter, ANDA 213605 · FDA approval letter, ANDA 213676 · FDA approval letter, ANDA 213748
In Q2 2026, US sales were −$2M, 0% of the $1,223M in Q2 2025, the last full quarter before copies.
The fastest collapse here: generics from MSN and Torrent launched in July 2025, and in Q2 2026 Novartis reported US net sales of minus $2M, meaning deductions such as returns and rebates exceeded new sales.
| Quarter | US sales | vs Q2 2025 |
|---|---|---|
| Q1 2025 | $1,169M | 96% |
| Q2 2025 | $1,223M | 100% |
| Q3 2025 · copies launch | $798M | 65% |
| Q4 2025 | $95M | 8% |
| Q1 2026 | $72M | 6% |
| Q2 2026 | −$2M | 0% |
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 →
Entresto was selected for the Medicare Drug Price Negotiation Program. Its negotiated Medicare price takes effect in 2026, 53% below its list price. CMS removed Entresto from the program from 1 January 2027 after US generics reached the market, so the negotiated price applies in 2026 only. US generics had already launched by then. 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 →
Entresto is 14% of Novartis's 2025 revenue ($7.7B of $54.5B). With Xolair, Cosentyx, Kisqali and Kesimpta, the drugs tracked here add up to 46% of Novartis's revenue losing US exclusivity by 2031.
Bars show each company's tracked drugs as a share of its total 2025 revenue. Entresto is highlighted.
CMS removes them from the program after generics or biosimilars reached the market; their prices applied in 2026 only.