Pharma Patent Cliffby readouts.io
Loss of exclusivity · Oncology

Xtandi patent expiration

Xtandi (Astellas and Pfizer) is expected to face US generic competition from 2027. Last listed US patent expires August 2027. Sales: Astellas global, ¥960.8B (fiscal year to March 2026).

US loss of exclusivity
2027Patent-expiry estimate
2025 worldwide sales
≈$6.0BAstellas and Pfizer
Therapeutic area
Oncology
Medicare negotiated price
−48%From 2027, vs list price
US competition from
GenericsUS date shown

What the date means

Xtandi's US exclusivity date is based on patent-expiry estimate. It is estimated from patent expiry rather than a fixed entry date, so it may move as patents are challenged or extended. It is a small-molecule drug, so copies are generics. Generic launches usually take most of the US volume within months.

Medicare price negotiation

Xtandi was selected for the Medicare Drug Price Negotiation Program. Its negotiated Medicare price takes effect in 2027, 48% 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.

What changed for Xtandi

  1. Medicare price
    Medicare prices set for Ozempic, Pomalyst, Ibrance and Xtandi

    From 2027: Ozempic 71%, Pomalyst 60%, Ibrance 50% and Xtandi 48% below list price. CMS

What's at stake for Astellas and Pfizer

Astellas
45%

Xtandi is 45% of Astellas's 2025 revenue (≈$6.0B of $13.4B). Total revenue ¥2,139.2B, fiscal year to March 2026.

Xtandi is 3.5% of Pfizer's 2025 revenue (≈$2.2B of $62.6B). With Ibrance, Eliquis and Prevnar 20, the drugs tracked here add up to 33% of Pfizer's revenue losing US exclusivity by 2035. Eliquis and Xtandi are Pfizer's reported alliance and product revenue ($8.0B, $2.2B).

Bars show each company's tracked drugs as a share of its total 2025 revenue. Xtandi is highlighted.

Other blockbusters losing US exclusivity in 2027

Sources

  1. Fierce Pharma
  2. CMS: negotiated prices for 2027
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