2028, date not disclosed
Gardasil expected to lose US exclusivity
Patent-expiry estimate. Key patents expire around 2028. Sales fell 39% in 2025 on weaker China demand.
When does Gardasil go off patent?
In the US, follow-on vaccines can launch from 2028. Gardasil is sold by Merck. Key patents expire around 2028. Sales fell 39% in 2025 on weaker China demand.
Gardasil'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 vaccine. Vaccines are hard to copy, so competition after patents expire usually arrives slowly.
| Patent or protection | Covers | Expiry |
|---|---|---|
| Key US patent | Gardasil and Gardasil 9 | 2028 |
| FDA 12-year biologic exclusivity | Gardasil 9, counted from approval on 10 December 2014 | 10 December 2026 |
| Gardasil 9 composition patents | Europe and Japan | 2030 |
| Original Gardasil patents | Europe, Japan and China | Expired |
Merck lists 2028 as the US expiry of the key patents for Gardasil and Gardasil 9, and 2030 for Gardasil 9's composition patents in Europe and Japan; the original Gardasil's patents have expired outside the US, and Gardasil 9's in China. Merck also pays a 7% US royalty on Gardasil that ends in December 2028. Vaccines are rarely copied, and we found no US copy in development; competition comes from rival HPV vaccines. Sales fell 39% in 2025, mainly on lower demand in China.
Sources: Merck 10-K 2025 · FDA Purple Book
| Year | Gardasil and Gardasil 9, Merck | US | Growth |
|---|---|---|---|
| 2021 | $5.67B | $1.88B | – |
| 2022 | $6.90B | $2.06B | +22% |
| 2023 | $8.89B | $2.08B | +29% |
| 2024 | $8.58B | $2.42B | -3% |
| 2025 | $5.23B | $2.64B | -39% |
Net sales as reported, with the US share. Sources: Merck 10-K 2025 · Merck 10-K 2023
No US filing found We found no US copy of Gardasil in development. Vaccines are rarely copied; competition usually comes from rival vaccines instead.
Checked October 2026. Sources: Merck 10-K 2025
Gardasil is 8% of Merck's 2025 revenue ($5.2B of $65.0B). With Januvia, Lynparza and Keytruda, 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. Gardasil is highlighted.
Patent-expiry estimate. Key patents expire around 2028. Sales fell 39% in 2025 on weaker China demand.