Pharma Patent Cliffby readouts.io
Loss of exclusivity · US · Immunology

Immunology drugs losing patent protection

Which immunology drugs go off patent, and when?

13 blockbuster immunology drugs with about $86.4B in 2025 worldwide sales lose US exclusivity between 2025 and 2037, led by Dupixent (Sanofi / Regeneron, $17.8B). 3 lose it in 2025 or 2026; the biggest single year is 2031, with $23.0B.

Immunology drugs tracked
133 losing exclusivity by 2026
2025 worldwide sales
≈$86.4B20% of the tracked cliff · #3 of 7 areas
Next five years
$40.4B7 drugs, 2027–2031
Most exposed company
AbbVie42% of 2025 revenue

Immunology 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 13 immunology drugs

DrugCompanyUS LOE2025 salesDate basisUS copiesMedicare price
Stelara Johnson & Johnson 2025 $6.1B Biosimilars launched Copies on the US market 2026 · −66%
Xolair Roche / Novartis 2026 ≈$5.4B Biosimilars launched Copies on the US market 2028 · pending
Simponi Johnson & Johnson 2026 $2.7B Company guidance Approved, waiting to launch –
Otezla Amgen 2028 $2.3B Settlement / court date Approved, waiting to launch 2027 · −65%
Cosentyx Novartis 2029 $6.7B Patent-expiry estimate In clinical trials 2028 · pending
Nucala GSK 2029 ≈$2.6B Patent-expiry estimate In clinical trials –
Enbrel Amgen 2029 $2.2B Settlement / court date Approved, waiting to launch 2026 · −67%
Taltz Eli Lilly 2030 $3.6B Company guidance In clinical trials –
Dupixent Sanofi / Regeneron 2031 $17.8B Company guidance In clinical trials –
Tremfya Johnson & Johnson 2031 $5.2B Company guidance In clinical trials –
Entyvio Takeda 2032 ≈$6.0B Company guidance Filed with the FDA 2028 · pending
Skyrizi AbbVie 2033 $17.6B Company guidance No US filing found –
Rinvoq AbbVie 2037 $8.3B Settlement / court date Filed with the FDA –

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

Companies most exposed in immunology

CompanyDrugs2025 revenue from themShare of company
AbbVieSkyrizi and Rinvoq$25.9B42%
SanofiDupixent≈$17.8B36%
Johnson & JohnsonStelara, Simponi and Tremfya$13.9B15%
NovartisXolair and Cosentyx$8.4B15%
TakedaEntyvio≈$6.0B21%
RegeneronDupixent$5.2B37%
AmgenOtezla and Enbrel$4.5B12%
RocheXolair≈$3.7B5%
Eli LillyTaltz$3.6B5.5%
GSKNucala≈$2.6B6.1%

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

Stelara (2026, −66%), Xolair (2028, price pending), Otezla (2027, −65%), Cosentyx (2028, price pending), Enbrel (2026, −67%) and Entyvio (2028, price pending) were selected for Medicare price negotiation. See every negotiated Medicare price →

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

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