Otezla (Amgen) is expected to face US generic competition from 2028. A court barred generics until the key US patent expires on 16 February 2028; Amgen settled with other filers. A newer extended-release version has patents to 2042.
Otezla's US exclusivity date is based on settlement / court date. Litigation settlements or a court ruling fix the earliest US entry date, which makes it one of the firmer dates in this tracker. It is a small-molecule drug, so copies are generics. Generic launches usually take most of the US volume within months.
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 →
Filed with the FDA A court barred Sandoz and Zydus from launching before the key patent expires on 16 February 2028. Amgen settled with Cipla, Torrent and Alkem in 2021 on confidential terms.
| Company (product) | Stage |
|---|---|
| Sandoz | Barred by court until Feb 2028 |
| Zydus | Barred by court until Feb 2028 |
| Cipla, Torrent, Alkem | Settled in 2021, terms confidential |
Checked September 2026. Sources: Fierce Pharma · Amgen press release
Otezla was selected for the Medicare Drug Price Negotiation Program. Its negotiated Medicare price takes effect in 2027, 65% below its list price. That is 1 year before US generics can launch, so Medicare revenue comes under pressure first. 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.
Otezla is 6.2% of Amgen's 2025 revenue ($2.3B of $36.8B). With Prolia, Xgeva, Repatha and Enbrel, the drugs tracked here add up to 38% of Amgen's revenue losing US exclusivity by 2029.
Bars show each company's tracked drugs as a share of its total 2025 revenue. Otezla is highlighted.