When does Januvia go off patent?
It already has: US generics have been on sale since 2026. Januvia is sold by Merck. US generics launched in May 2026 under settlements with more than two dozen companies. Sales include Janumet ($0.94B); Januvia alone was $1.60B.
Januvia's US exclusivity date is based on generics launched. US generics have already launched, so the loss of exclusivity is under way. 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 →
Copies on the US market US generics launched in late May 2026 under settlements Merck reached with more than two dozen companies; generic Janumet XR followed in July 2026.
| Company (product) | Stage |
|---|---|
| Teva (Watson) | FDA-approved Dec 2025; launched May 2026 |
| Sandoz | FDA-approved Jan 2026; launched May 2026 |
| Apotex | FDA-approved Jan 2026 |
From the FDA's own approval lists; FDA approval does not always mean a product has launched. Checked October 2026. Sources: Merck 10-Q, Q2 2026 · FDA Orange Book: Januvia patents
Januvia was selected for the Medicare Drug Price Negotiation Program. Its negotiated Medicare price takes effect in 2026, 79% 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.
Januvia is 3.9% of Merck's 2025 revenue ($2.5B of $65.0B). With Lynparza, Keytruda and Gardasil, the drugs tracked here add up to 63% of Merck's revenue losing US exclusivity by 2028.
Bars show each company's tracked drugs as a share of its total 2025 revenue. Januvia is highlighted.