Pharma Patent Cliffby readouts.io
Loss of exclusivity · Vaccines

Gardasil patent expiration

Gardasil (Merck) is expected to face US follow-on vaccine competition from 2028. Key patents expire around 2028. Sales fell 39% in 2025 on weaker China demand.

US loss of exclusivity
2028Patent-expiry estimate
2025 worldwide sales
$5.2BMerck
Therapeutic area
Vaccines
US competition from
Follow-on vaccinesUS date shown

What the date means

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.

What's at stake for Merck

Gardasil is 8% of Merck's 2025 revenue ($5.2B of $65.0B). With Keytruda, the drugs tracked here add up to 57% 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.

Other blockbusters losing US exclusivity in 2028

Sources

  1. Merck FY2025
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