When does Erleada go off patent?
In the US, generics can launch from 2033. Erleada is sold by Johnson & Johnson. Drug substance patents listed with the FDA run to 2032 and 2033, with use patents to 2041. J&J sued Lupin and Hetero over generic filings; Lupin settled in August 2025 on confidential terms.
Erleada'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.
Filed with the FDA Lupin and Hetero filed to sell generic apalutamide and were sued in 2025. Lupin settled in August 2025 on confidential terms.
Checked October 2026. Sources: J&J 10-K 2025
Patent-expiry estimate. Drug substance patents listed with the FDA run to 2032 and 2033, with use patents to 2041. J&J sued Lupin and Hetero over generic filings; Lupin settled in August 2025 on confidential terms.
Among past small-molecule drugs facing generics: Tecfidera's US sales fell to 21% of their 2019 level in its first full year of generics (2021); Revlimid's US sales fell to 96% of their 2021 level in its first full year of generics (2022) and 57% two years later. Where settlements cap generic volumes, as with Revlimid, the decline is slower. See how past cliffs played out →
Erleada 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 5 years before US generics 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.
Erleada is 3.8% of Johnson & Johnson's 2025 revenue ($3.6B of $94.2B). With Stelara, Xarelto, Simponi, Opsumit, Darzalex, Tremfya, Invega Sustenna and Imbruvica, the drugs tracked here add up to 46% of Johnson & Johnson's revenue losing US exclusivity by 2033. Total includes MedTech.
Bars show each company's tracked drugs as a share of its total 2025 revenue. Erleada is highlighted.