Entyvio (Takeda) is expected to face US biosimilar competition from 2032. 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.
Entyvio was selected for the Medicare Drug Price Negotiation Program. CMS is negotiating its Medicare price now; the price takes effect in 2028 and is due to be published 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.
Takeda moved its assumption from May 2026 by three to five years, citing formulation, dosing and manufacturing patents. Pharma Japan
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.