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Loss of exclusivity · US · Oncology

Oncology drugs losing patent protection

Which cancer drugs go off patent, and when?

20 blockbuster cancer drugs with about $126.0B in 2025 worldwide sales lose US exclusivity between 2025 and 2037, led by Keytruda (Merck, $31.7B). 3 lose it in 2025 or 2026; the biggest single year is 2028, with $49.1B.

Oncology drugs tracked
203 losing exclusivity by 2026
2025 worldwide sales
≈$126.0B29% of the tracked cliff · #2 of 7 areas
Next five years
$95.6B12 drugs, 2027–2031
Most exposed company
Merck51% of 2025 revenue

Oncology sales losing US exclusivity, by year

2025 worldwide sales of each drug, placed in the year its first US generic or biosimilar can launch. Select a year for every drug going off patent that year.

The 20 cancer drugs

DrugCompanyUS LOE2025 salesDate basisUS copiesMedicare price
Xgeva Amgen 2025 $2.1B Biosimilars launched Copies on the US market –
Perjeta Roche 2026 ≈$3.6B Company guidance Approved, waiting to launch –
Pomalyst Bristol Myers Squibb 2026 $2.7B Generics launched Copies on the US market 2027 · −60%
Xtandi Astellas / Pfizer 2027 ≈$6.0B Patent-expiry estimate Approved, waiting to launch 2027 · −48%
Ibrance Pfizer 2027 $4.1B Patent-expiry estimate Filed with the FDA 2027 · −50%
Lynparza AstraZeneca / Merck 2027 $3.3B Company guidance Tentatively approved –
Keytruda Merck 2028 $31.7B Company guidance In clinical trials –
Opdivo Bristol Myers Squibb 2028 $10.1B Company guidance Filed with the FDA –
Tecentriq Roche 2028 ≈$4.3B Patent-expiry estimate No US filing found –
Jakafi Incyte 2028 $3.1B Company guidance Filed with the FDA –
Darzalex Johnson & Johnson 2029 $14.3B Patent-expiry estimate In clinical trials –
Imfinzi AstraZeneca 2031 $6.1B Company guidance Early development –
Verzenio Eli Lilly 2031 $5.7B Company guidance No US filing found 2028 · pending
Kisqali Novartis 2031 $4.8B Company guidance No US filing found 2028 · pending
Cabometyx Exelixis 2031 $2.1B Settlement / court date Approved, waiting to launch –
Tagrisso AstraZeneca 2032 $7.3B Patent-expiry estimate No US filing found –
Imbruvica AbbVie / Johnson & Johnson 2032 $4.9B Settlement / court date Approved, waiting to launch 2026 · −38%
Calquence AstraZeneca 2032 $3.5B Patent-expiry estimate Filed with the FDA 2027 · −40%
Venclexta AbbVie 2032 $2.8B Patent-expiry estimate Filed with the FDA –
Erleada Johnson & Johnson 2033 $3.6B Patent-expiry estimate Filed with the FDA 2028 · pending

Sorted by the year US exclusivity ends. Each drug's page has the sources.

Companies most exposed in oncology

CompanyDrugs2025 revenue from themShare of company
MerckLynparza and Keytruda$33.1B51%
Johnson & JohnsonDarzalex, Imbruvica and Erleada$20.7B22%
AstraZenecaLynparza, Imfinzi, Tagrisso and Calquence$20.2B34%
Bristol Myers SquibbPomalyst and Opdivo$12.8B27%
RochePerjeta and Tecentriq≈$7.9B11%
PfizerXtandi and Ibrance$6.3B10%
AstellasXtandi≈$6.0B45%
Eli LillyVerzenio$5.7B8.8%
AbbVieImbruvica and Venclexta$5.7B9.2%
NovartisKisqali$4.8B8.8%

For shared drugs, each company is credited with the revenue it reports, so nothing is counted twice. Share is of the company's total 2025 revenue.

Medicare price negotiation

Pomalyst (2027, −60%), Xtandi (2027, −48%), Ibrance (2027, −50%), Verzenio (2028, price pending), Kisqali (2028, price pending), Imbruvica (2026, −38%), Calquence (2027, −40%) and Erleada (2028, price pending) were selected for Medicare price negotiation. See every negotiated Medicare price →

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Pharma Patent Cliff by readouts.io. "Oncology drugs losing patent protection." Updated 8 October 2026. https://pharmapatentcliff.com/areas/oncology

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