When does Entyvio go off patent?
In the US, biosimilars can launch from 2032. Entyvio is sold by Takeda. Takeda pushed its assumed US biosimilar entry back to 2032 on formulation and manufacturing patents. Sales ¥958.0B (fiscal year to March 2026).
Entyvio's US exclusivity date is based on company guidance. The date comes from the company's own filings or guidance. Secondary patents, new formulations or litigation can still move it. It is a biologic, so copies are biosimilars. Biosimilars are harder to make and usually erode sales more gradually than generics.
| Patent or protection | Covers | Expiry |
|---|---|---|
| FDA 12-year biologic exclusivity (ended) | Counted from approval on 20 May 2014 | 20 May 2026 |
| Formulation, dosing and manufacturing patents | Vedolizumab (Takeda lists no basic patent left in the US or Europe) | 2032 |
| Japan re-examination period | Entyvio | July 2028 |
| UK and Netherlands | Revocation suits against dosing and formulation patents, filed February to April 2026 | Pending |
Takeda lists no remaining basic patent on vedolizumab in the US or Europe. Its US protection now rests on patents covering the formulation, dosing and manufacturing, some of which expire in 2032, and Takeda says a biosimilar launching earlier would have to get past all of them. Two biosimilars are under FDA review (Alvotech with Teva, and Polpharma with Fresenius Kabi), and Takeda sued both in 2026. In Europe, other companies filed suits in 2026 in the UK and the Netherlands to revoke some of the dosing and formulation patents.
Sources: Takeda 20-F, fiscal 2025 · FDA Purple Book
| Year | Worldwide | US | Growth |
|---|---|---|---|
| 2021 | JPY 521.8B | JPY 349.5B | – |
| 2022 | JPY 702.7B | JPY 491.9B | +35% |
| 2023 | JPY 800.9B | JPY 546.1B | +14% |
| 2024 | JPY 914.1B | JPY 619.2B | +14% |
| 2025 | JPY 958.0B | JPY 623.7B | +5% |
Takeda fiscal years run from April to March, so 2025 is April 2025 to March 2026. US 2021 is fiscal 2022 US sales less the increase Takeda reports. Worldwide net sales as reported, with the US share, in JPY as the company reports them, so growth is not distorted by exchange rates. Sources: Takeda 20-F, fiscal 2025 · Takeda 20-F, fiscal 2023 · Takeda 20-F, fiscal 2022
Filed with the FDA Two biosimilars are under FDA review: Alvotech's, sold in the US by Teva, accepted in June 2026 with a decision expected in the first quarter of 2027, and Polpharma's, partnered with Fresenius Kabi, accepted in July 2026. Takeda sued both in August and September 2026 over six patents, and assumes US biosimilar entry in 2032.
| Company (product) | Stage |
|---|---|
| Alvotech / Teva (AVT16) | Filed with the FDA; in litigation, sued Sep 2026. FDA decision expected Q1 2027 |
| Polpharma / Fresenius Kabi (PB016) | Filed with the FDA Jul 2026; in litigation, sued Aug 2026. FDA accepted the filing in Jul 2026 |
| Samsung Bioepis | Early development. Announced Jan 2026 |
Checked October 2026. Sources: Pearce IP: Takeda sues Alvotech · Pearce IP: Takeda sues Polpharma · Alvotech press release · Pearce IP: Samsung Bioepis pipeline · Managed Healthcare Executive: Takeda patents
Among past biologics facing biosimilars, US sales in the first full year after copies arrived were a median 65% of the last full year before (range 34% to 93%, 7 drugs), and 27% by the third year (9 drugs). Biosimilars usually take share more gradually than generics. Every drug is different: settlements, how many copies launch, and pricing all change the curve. See the erosion benchmarks →
Entyvio was selected for the Medicare Drug Price Negotiation Program. CMS must publish the negotiated prices for 2028 by 30 November 2026. That is 4 years before US biosimilars can launch, so Medicare revenue comes under pressure first. For the 25 drugs negotiated so far, Medicare prices came in 38% to 85% below list price. Those discounts are measured before the rebates drugmakers already pay and apply to Medicare only. See every negotiated Medicare price →
Entyvio is 21% of Takeda's 2025 revenue (≈$6.0B of $28.3B). Core revenue ¥4,505.7B, fiscal year to March 2026.
Bars show each company's tracked drugs as a share of its total 2025 revenue. Entyvio is highlighted.
Deadline for CMS to publish the negotiated prices for the drugs selected for 2028. The prices take effect on 1 January 2028. Xeljanz will have none, because CMS found a generic on sale.
Alvotech's application, with Teva as US seller, was accepted in June 2026. Takeda says patents running to 2032 still have to be cleared before launch.
Prices are due from CMS by 30 November 2026.
Company guidance. Takeda pushed its assumed US biosimilar entry back to 2032 on formulation and manufacturing patents. Sales ¥958.0B (fiscal year to March 2026).
Takeda moved its assumption from May 2026 by three to five years, citing formulation, dosing and manufacturing patents. Pharma Japan