Pharma Patent Cliffby readouts.io
Loss of exclusivity · Cardiometabolic

Trulicity patent expiration

Trulicity (Eli Lilly) is expected to face US biosimilar competition from 2027. Lilly 10-K: US compound patent and data protection end 2027.

US loss of exclusivity
2027Company guidance
2025 worldwide sales
$4.3BEli Lilly
Therapeutic area
Cardiometabolic
Medicare negotiated price
PendingTakes effect 2028
US competition from
BiosimilarsUS date shown

What the date means

Trulicity'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.

Medicare price negotiation

Trulicity 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. US biosimilars are due by then. 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.

What changed for Trulicity

  1. Medicare price
    Trulicity, Biktarvy, Cosentyx and Entyvio selected for Medicare price negotiation

    Negotiated prices take effect in 2028. CMS must publish them by 30 November 2026. CMS

What's at stake for Eli Lilly

Eli Lilly
42%

Trulicity is 6.6% of Eli Lilly's 2025 revenue ($4.3B of $65.2B). With Mounjaro, the drugs tracked here add up to 42% of Eli Lilly's revenue losing US exclusivity by 2036.

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

Other blockbusters losing US exclusivity in 2027

Sources

  1. Lilly 10-K
  2. CMS: drugs selected for 2028
See all 26 drugs on the patent cliff →