Pharma Patent Cliffby readouts.io
Loss of exclusivity · US · 2025–2037

The pharma patent cliff

Blockbuster drugs grouped by the year the first US generic or biosimilar can launch. Each block is sized by the drug's 2025 worldwide sales, the revenue its owner has to replace.

2025 sales exposed, by US loss-of-exclusivity year ($B)

Date fixed (launched, settled or guided) Estimated from patent expiry ex-US Exclusivity ends earlier outside the US M Medicare negotiated price

What changed

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  1. Copies in the works
    Biocon settles with Genentech over its Perjeta biosimilar

    The settlement allows Biocon to launch Pebrilzo in the US from Q3 2028, and in Europe and the UK from early 2027. Henlius and Organon's Poherdy is already FDA-approved. Biocon

  2. Copies in the works
    FDA accepts the first Keytruda biosimilar application

    Formycon and Zydus's FYB206 is the first publicly announced Keytruda biosimilar under FDA review; a decision is expected in Q3 2027. Merck's primary US compound patent expires in December 2028. Formycon and Zydus

  3. US copies launched
    Celltrion launches the first US Xolair biosimilar

    Omlyclo, interchangeable with Xolair, launched at a list price about 15% lower, with a preferred spot on Optum's commercial formulary. Xolair's US sales were CHF 3.08B in 2025. Celltrion

  4. US copies launched
    FDA approves Teva's Xgeva biosimilar

    Degevma makes 10 approved Xgeva biosimilars; Teva expects to launch it, and its Prolia version, in the coming months. Teva

  5. Copies in the works
    Mylan sues to clear a newer Wegovy patent

    The patent, granted in February 2026 and running to 2038, covers weekly weight-loss dosing; Novo's compound patent still runs to 2032. Pearce IP

All 36 changes →
Data table and sources ( drugs)
US LOEDrugCompanyArea2025 salesDate basisCopies lined upMedicare priceNoteSources
2025 Entresto Novartis Cardiometabolic $7.7B Generics launched Copies on the US market 2026 only · −53% US generics entered in Q3 2025. Novartis Q4 2025
CMS: negotiated prices for 2026
2025 Stelara Johnson & Johnson Immunology $6.1B Biosimilars launched Copies on the US market 2026 only · −66% US biosimilars from Jan 2025. Sales were $10.4B in 2024, before entry. J&J FY2025
CMS: negotiated prices for 2026
2025 Xarelto Bayer / Johnson & Johnson Cardiometabolic ≈$5.3B Generics launched Copies on the US market 2026 only · −62% The first US generic launched in March 2025. Sales: J&J in the US ($2.63B) plus Bayer elsewhere (EUR 2.34B, down a third as generics spread in Europe and Japan). J&J 10-K 2025
Bayer Annual Report 2025
CMS: negotiated prices for 2026
2025 Prolia Amgen Other $4.4B Biosimilars launched Copies on the US market – Denosumab biosimilars launched in the US from mid-2025. Bone health. Amgen FY2025
2025 Xgeva Amgen Oncology $2.1B Biosimilars launched Copies on the US market – Amgen's US patents expired in February 2025 and denosumab biosimilars launched later that year. Prevents bone complications in cancer. Amgen 10-K 2025
2026 Farxiga AstraZeneca Cardiometabolic $8.4B Generics launched Copies on the US market 2026 · −68% FDA approved the first US generics on 6 April 2026. AZ FY2025
FDA
CMS: negotiated prices for 2026
2026 Xolair Roche / Novartis Immunology ≈$5.4B Biosimilars launched Copies on the US market 2028 · under review Celltrion launched Omlyclo, the first US biosimilar, on 5 October 2026 under a settlement with Genentech. Sales: Roche in the US (CHF 3.08B, up 32% on food allergy use) plus Novartis elsewhere ($1.72B). Roche Finance Report 2025
Novartis 20-F 2025
Celltrion launch release
CMS: drugs selected for 2028
2026 Perjeta Roche Oncology ≈$3.6B Company guidance Approved, waiting to launch – Roche says its primary US and EU patents expired in Q2 2025 and expects the first biosimilars in 2026. Sales CHF 2.97B, down 13% as patients move to Phesgo, which combines Perjeta and Herceptin in one injection. Roche Finance Report 2025
2026 Pomalyst Bristol Myers Squibb Oncology $2.7B Generics launched Copies on the US market 2027 · −60% US generics launched March 2026 under settlements. BMS FY2025
CMS: negotiated prices for 2027
2026 Simponi Johnson & Johnson Immunology $2.7B Company guidance Approved, waiting to launch – The FDA approved the first biosimilars, Bio-Thera's Immgolis, in May 2026, and Accord BioPharma plans a US launch in Q4 2026. Sales include the IV form Simponi Aria. Accord BioPharma release
J&J 10-K 2025
2026 Januvia Merck Cardiometabolic $2.5B Generics launched Copies on the US market 2026 · −79% US generics launched in May 2026 under settlements with more than two dozen companies. Sales include Janumet ($0.94B); Januvia alone was $1.60B. Merck 10-K 2025
Merck 10-Q, Q2 2026
CMS: negotiated prices for 2026
2026 Opsumit Johnson & Johnson Other $2.3B Generics launched Copies on the US market – US generics entered late in Q2 2026, J&J says. Pulmonary arterial hypertension. Sales include Opsynvi, which combines macitentan with tadalafil. J&J 10-Q, Q2 2026
J&J 10-K 2025
2027 Xtandi Astellas / Pfizer Oncology ≈$6.0B Patent-expiry estimate Approved, waiting to launch 2027 · −48% Last listed US patent expires August 2027. Sales: Astellas global, ¥960.8B (fiscal year to March 2026). Fierce Pharma
CMS: negotiated prices for 2027
2027 Trulicity Eli Lilly Cardiometabolic $4.3B Company guidance Early development 2028 · pending Lilly 10-K: US compound patent and data protection end 2027. Lilly 10-K
CMS: drugs selected for 2028
2027 Ibrance Pfizer Oncology $4.1B Patent-expiry estimate Filed with the FDA 2027 · −50% US patent term extended to March 2027, and pediatric exclusivity to September 2027. Pfizer FY2025
Pfizer PTE
FDA Orange Book data files
CMS: negotiated prices for 2027
2027 Trelegy GSK Other ≈$3.9B Patent-expiry estimate Filed with the FDA 2027 · −73% GSK's latest US compound patent expires in 2027, but inhaler and formulation patents run to 2030 (2031 with pediatric exclusivity). Sales GBP 2,986M. GSK 20-F 2025
FDA Orange Book: Trelegy patents
CMS: negotiated prices for 2027
2027 Lynparza AstraZeneca / Merck Oncology $3.3B Company guidance Tentatively approved – Merck 10-K: US basic patent 2027. AstraZeneca and Merck have sued generic filers since 2023. Sales as reported by AstraZeneca; Merck books $1.5B of alliance revenue. Merck 10-K 2025
AstraZeneca 20-F 2025
2028 Keytruda Merck Oncology $31.7B Company guidance Filed with the FDA – Primary US compound patent expires December 2028. Includes subcutaneous Keytruda Qlex. EU exclusivity to 2031. Merck FY2025
Merck 10-K
2028 Eliquis Bristol Myers Squibb / Pfizer Cardiometabolic $14.4B Settlement / court date Approved, waiting to launch 2026 · −56% US generics barred until 1 April 2028 after patent win and settlements. EU generics earlier. Sales as reported by BMS; Pfizer separately books $8.0B of alliance and product revenue. BMS FY2025
CMS: negotiated prices for 2026
2028 Opdivo Bristol Myers Squibb Oncology $10.1B Company guidance Filed with the FDA – BMS guides to US biosimilar entry from 2028. Subcutaneous Opdivo Qvantig may extend the franchise. BMS FY2025
2028 Gardasil Merck Vaccines $5.2B Patent-expiry estimate No US filing found – Key patents expire around 2028. Sales fell 39% in 2025 on weaker China demand. Merck FY2025
2028 Tecentriq Roche Oncology ≈$4.3B Patent-expiry estimate No US filing found – The 12-year US biologic exclusivity ends in May 2028. Roche does not publish Tecentriq's patent dates, which may run later. Sales CHF 3.57B. Roche Finance Report 2025
FDA Purple Book
2028 Jakafi Incyte Oncology $3.1B Company guidance Filed with the FDA – Incyte 10-K: estimated minimum US market exclusivity 2028, when the composition patents expire. Jakafi is 60% of Incyte's revenue. Incyte 10-K 2025
2028 Otezla Amgen Immunology $2.3B Settlement / court date Approved, waiting to launch 2027 · −65% A court barred generics until the key US patent expires on 16 February 2028, and Amgen says pediatric exclusivity on that patent runs to 16 August 2028. Amgen settled with other filers. A newer extended-release version has patents to 2042. Amgen 10-K 2025
Fierce Pharma
CMS: negotiated prices for 2027
2029 Darzalex Johnson & Johnson Oncology $14.3B Patent-expiry estimate In clinical trials – Core US patents expire 2029. Formulation patents on subcutaneous Darzalex Faspro run longer. J&J FY2025
2029 Jardiance Boehringer Ingelheim / Eli Lilly Cardiometabolic ≈$9.9B Company guidance Approved, waiting to launch 2026 · −66% Lilly's 10-K puts US compound patent expiry at 2029, including pediatric exclusivity; later use patents run to 2034. Sales: Boehringer Ingelheim, EUR 8.8B for the Jardiance family; Lilly separately books $3.4B. Boehringer Ingelheim FY2025
Lilly 10-K 2025
CMS: negotiated prices for 2026
2029 Ocrevus Roche Neuroscience ≈$8.4B Patent-expiry estimate In clinical trials – Main US patent protection runs to March 2029. Sales CHF 7.01B. Roche FY2025
2029 Cosentyx Novartis Immunology $6.7B Patent-expiry estimate In clinical trials 2028 · pending Key exclusivities expected to end around 2029. Novartis Q4 2025
CMS: drugs selected for 2028
2029 Shingrix GSK Vaccines ≈$4.8B Patent-expiry estimate No US filing found – GSK's 20-F lists the main US patent to 2029. Sales GBP 3.6B; the US share is falling as fewer unvaccinated adults remain, and two thirds of sales now come from outside the US. GSK 20-F 2025
2029 Vraylar AbbVie Neuroscience $3.6B Patent-expiry estimate Approved, waiting to launch 2027 · −44% The compound patent runs to June 2029 with pediatric exclusivity; a second compound and use patent runs to March 2030. Settlement terms with generic makers have not been disclosed. AbbVie 10-K 2025
FDA Orange Book: Vraylar patents
CMS: negotiated prices for 2027
2029 Repatha Amgen Cardiometabolic $3.0B Patent-expiry estimate No US filing found – Amgen 10-K: US antibody patent expires 27 August 2029; a methods-of-treatment patent runs to May 2032. Amgen 10-K 2025
2029 Nucala GSK Immunology ≈$2.6B Patent-expiry estimate In clinical trials – GSK's 20-F lists the latest US molecule patent to 2029, with other patents to 2036. The 12-year US biologic exclusivity ends in November 2027. Sales GBP 2.01B, up 15% at constant currency. GSK 20-F 2025
FDA Purple Book
2029 Enbrel Amgen Immunology $2.2B Settlement / court date Approved, waiting to launch 2026 · −67% Court-upheld patents block approved biosimilars until April 2029. Amgen FY2025
GaBI
CMS: negotiated prices for 2026
2030 Taltz Eli Lilly Immunology $3.6B Company guidance In clinical trials – Lilly 10-K: US compound patent 2030; US biologics data protection runs to 2028. Lilly 10-K 2025
2031 Dupixent Sanofi / Regeneron Immunology $17.8B Company guidance In clinical trials – Extended US patent runs to 28 March 2031. Sanofi plans to defend exclusivity beyond that. Regeneron FY2025
Fierce Pharma
2031 Vyndaqel Pfizer Cardiometabolic $6.4B Settlement / court date Filed with the FDA – April 2026 settlements extend the effective US patent expiry for Vyndamax to 1 June 2031, subject to a case against Apotex that is still going; Pfizer had expected US sales to start falling in 2029. Sales are the Vyndaqel family (Vyndaqel and Vyndamax), for a rare heart disease. Pfizer Q1 2026 results
Pfizer 10-Q, Q2 2026
2031 Imfinzi AstraZeneca Oncology $6.1B Company guidance Early development – AstraZeneca 20-F: US patent protection expected to 2031. AstraZeneca 20-F 2025
2031 Verzenio Eli Lilly Oncology $5.7B Company guidance No US filing found 2028 · pending Lilly 10-K: US compound patent 2031. Lilly 10-K 2025
CMS: drugs selected for 2028
2031 Tremfya Johnson & Johnson Immunology $5.2B Company guidance In clinical trials – J&J 10-K: US composition patent family projected to expire in 2031. Sales grew 40% in 2025, which J&J attributes to share gains and market growth. J&J 10-K 2025
2031 Kisqali Novartis Oncology $4.8B Company guidance No US filing found 2028 · pending Novartis 20-F: US compound patent 2031. Sales grew 58% in 2025. Novartis 20-F 2025
CMS: drugs selected for 2028
2031 Kesimpta Novartis Neuroscience $4.4B Company guidance Early development – Novartis 20-F: US compound patent 2031 (already expired in Europe). Multiple sclerosis; sales grew 37% in 2025. Novartis 20-F 2025
2031 Invega Sustenna Johnson & Johnson Neuroscience $3.8B Patent-expiry estimate Filed with the FDA – The one listed US patent, a dosing patent, runs to January 2031 and was upheld at trial against Tolmar; J&J has since won or settled against every challenger. Sales include the longer-acting Invega Trinza and the ex-US brands Xeplion and Trevicta. J&J 10-K 2025
FDA Orange Book: Invega Sustenna patents
Law360: J&J, Tolmar settle
2031 Descovy Gilead Infectious disease $2.8B Company guidance Approved, waiting to launch – Gilead 10-K: US patent expiry 2031 (Europe 2027). Gilead sued Cipla in February 2026 over a patent challenge. HIV treatment and prevention. Gilead 10-K 2025
2031 Reblozyl Bristol Myers Squibb Other $2.3B Company guidance No US filing found – BMS estimates US exclusivity to 2031, based on regulatory exclusivity; a method-of-treatment patent with term restoration runs to 2033. Anemia in MDS and beta thalassemia. BMS 10-K 2025
2031 Cabometyx Exelixis Oncology $2.1B Settlement / court date Approved, waiting to launch – Settlements with Teva and Cipla allow US generics from 1 January 2031; a court upheld other patents against MSN. US sales, recorded by Exelixis. Exelixis 10-K 2025
Fierce Pharma
2032 Ozempic Novo Nordisk Cardiometabolic ≈$19.3B Company guidance Tentatively approved 2027 · −71% Novo guides to US compound patent expiry in 2032. Generics launched in India and Canada in 2026 as patents lapsed there. Sales DKK 127.1B. Novo AR 2025
Novo Q1 2026 (India generics)
Dr. Reddy's (Canada launch)
CMS: negotiated prices for 2027
2032 Wegovy Novo Nordisk Cardiometabolic ≈$12.0B Company guidance Filed with the FDA 2027 · −71% Same molecule as Ozempic (semaglutide), sold for obesity. Novo: US compound patent expiry 2032; semaglutide generics launched in India and Canada in 2026. Sales DKK 79.1B. Novo 20-F 2025
CMS: negotiated prices for 2027
2032 Tagrisso AstraZeneca Oncology $7.3B Patent-expiry estimate No US filing found – Core US patents expire in 2032. Later patents cover the formulation (2035) and one approved use (2042). AZ FY2025
2032 Entyvio Takeda Immunology ≈$6.0B Company guidance Filed with the FDA 2028 · pending Takeda pushed its assumed US biosimilar entry back to 2032 on formulation and manufacturing patents. Sales ¥958.0B (fiscal year to March 2026). Takeda FY2025
Pharma Japan
CMS: drugs selected for 2028
2032 Imbruvica AbbVie / Johnson & Johnson Oncology $4.0B Settlement / court date Approved, waiting to launch 2026 · −38% A court upheld the key patent in 2021; AbbVie expects no US generic before 30 March 2032, assuming pediatric exclusivity. Sales: AbbVie in the US ($2.05B) plus J&J outside the US ($1.93B). The revenue each company reports also includes its share of the other's profit, so the two add up to more. AbbVie 8-K, Aug 2021
AbbVie 10-K 2025
J&J 10-K 2025
CMS: negotiated prices for 2026
2032 Calquence AstraZeneca Oncology $3.5B Patent-expiry estimate Filed with the FDA 2027 · −40% AstraZeneca lists US patents expiring between 2026 and 2036; generic makers challenged them from 2024. AstraZeneca 20-F 2025
CMS: negotiated prices for 2027
2032 Venclexta AbbVie Oncology $2.8B Patent-expiry estimate Approved, waiting to launch – Compound patents listed with the FDA run to June 2031 and January 2032, with other patents to 2033. AbbVie books worldwide sales and shares US profit with Roche's Genentech. AbbVie 10-K 2025
FDA Orange Book: Venclexta patents
2033 Skyrizi AbbVie Immunology $17.6B Company guidance No US filing found – AbbVie 10-K: US composition-of-matter patents expire 2033. AbbVie 10-K
2033 Erleada Johnson & Johnson Oncology $3.6B Patent-expiry estimate Approved, waiting to launch 2028 · pending Drug substance patents listed with the FDA run to 2032 and 2033, with use patents to 2041. J&J sued Lupin and Hetero over generic filings; Lupin settled in August 2025 on confidential terms. J&J 10-K 2025
FDA Orange Book: Erleada patents
CMS: drugs selected for 2028
2034 Vabysmo Roche Other ≈$4.9B Patent-expiry estimate No US filing found – The 12-year US biologic exclusivity ends in January 2034. Roche does not publish Vabysmo's patent dates, which may run later. Eye diseases (wet AMD, diabetic macular edema). Sales CHF 4.10B. Roche Finance Report 2025
FDA Purple Book
2035 Prevnar 20 Pfizer Vaccines $6.5B Company guidance No US filing found – Pfizer 10-K: US basic product patent expires 2035. Sales are the whole Prevnar family. Pfizer 10-K
2035 Ultomiris AstraZeneca Other $4.7B Company guidance No US filing found – AstraZeneca 20-F: US patent protection expected to 2035. Rare immune and blood diseases. AstraZeneca 20-F 2025
2036 Mounjaro Eli Lilly Cardiometabolic $23.0B Company guidance Filed with the FDA – Lilly 10-K: US compound patent expires 2036. Excludes Zepbound, the same molecule sold for obesity. Lilly 10-K
2036 Biktarvy Gilead Infectious disease $14.3B Settlement / court date Filed with the FDA 2028 · pending Settlements bar US generics before 1 April 2036, later than the earlier 2033 estimate. Gilead FY2025
Fierce Pharma
CMS: drugs selected for 2028
2036 Zepbound Eli Lilly Cardiometabolic $13.5B Company guidance Filed with the FDA – Same molecule as Mounjaro (tirzepatide), sold for obesity. Lilly 10-K: US compound patent 2036. Lilly 10-K 2025
2036 Vyvgart argenx Neuroscience $4.2B Patent-expiry estimate No US filing found – argenx: the US composition-of-matter patent expires in 2036, before any extension, and 12-year biologic exclusivity runs to December 2033. Myasthenia gravis and CIDP. Sales are argenx's product net sales, including Vyvgart Hytrulo. argenx 20-F 2025
2037 Trikafta Vertex Other $10.3B Patent-expiry estimate No US filing found – Patents run to about 2037. Cystic fibrosis. Excludes the successor Alyftrek ($0.8B). Vertex FY2025
2037 Rinvoq AbbVie Immunology $8.3B Settlement / court date Filed with the FDA – September 2025 settlements bar US generics before April 2037. Consensus had assumed 2032. AbbVie 10-K
Fierce Pharma

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Pharma Patent Cliff by readouts.io. "The pharma patent cliff: blockbuster drugs by US loss-of-exclusivity year, 2025–2037." Updated 24 October 2026. https://pharmapatentcliff.com/

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