In 2025, Blockbuster drugs like Stelara, Eylea, and Entresto face U.S. exclusivity loss, opening doors for generics and biosimilars in a shifting pharma market.
Each year, the pharmaceutical industry witnesses a wave of blockbuster drugs losing their market exclusivity, paving the way for generic and biosimilar competition. However, 2025 stands out due to the high-profile nature of the drugs facing the so-called “patent cliff.” Leading the pack is Johnson & Johnson’s immunology giant Stelara, which is already battling a flood of biosimilars. Several other major drugs—including Regeneron’s Eylea, Amgen’s Prolia/Xgeva, and Novartis’ Entresto—are also set to lose exclusivity, marking a significant shift in the pharmaceutical landscape. Below, we delve into the details of the major patent expirations set to reshape the market.
1. Stelara
Disease: Psoriatic arthritis, plaque psoriasis, Crohn’s disease, ulcerative colitis
Company: Johnson & Johnson
2024 U.S. Sales: $6.72 billion
Stelara has long been a cornerstone of Johnson & Johnson’s immunology portfolio. While it successfully delayed biosimilar competition through legal settlements, 2025 will see multiple biosimilars enter the market, including Amgen’s Wezlana, Teva/Alvotech’s Selarsdi, and Sandoz’s Pyzchiva. The impact is already evident in international markets where J&J has faced revenue declines. To mitigate losses, J&J is shifting its focus to newer immunology drugs like Tremfya, hoping to sustain its dominance in the space.
2. Entresto
Disease: Heart failure
Company: Novartis
2024 U.S. Sales: $3.88 billion
Novartis’ heart failure drug Entresto has been a major growth driver, but its key patent expires in mid-2025. With several generic manufacturers poised for launch, Novartis anticipates a substantial revenue hit. Despite this, the company is actively developing next-generation cardiovascular therapies to maintain its market share in the heart failure segment.
3. Ocrevus
Disease: Multiple sclerosis
Company: Roche
2024 U.S. Sales: $5.3 billion
Since its 2017 approval, Ocrevus has dominated the multiple sclerosis market, offering strong efficacy and convenient twice-yearly dosing. Biosimilars from Samsung Bioepis and Biocon threaten its market position, but Roche is countering with a subcutaneous version. While Novartis’ Kesimpta is emerging as a competitor, Ocrevus remains a preferred choice among physicians and patients.
4. Ibrance
Disease: HR-positive, HER2-negative breast cancer
Company: Pfizer
2024 U.S. Sales: $2.7 billion
Ibrance pioneered CDK4/6 inhibition in breast cancer, but it now faces competition from Novartis’ Kisqali and Eli Lilly’s Verzenio, both of which have demonstrated better survival benefits. While generics are expected in 2027, Pfizer’s market share is already eroding. The company is focusing on combination strategies to maintain its relevance in the oncology space.
5. Tagrisso
Disease: Non-small cell lung cancer
Company: AstraZeneca
2024 U.S. Sales: $3.9 billion
AstraZeneca’s Tagrisso has been the standard of care for EGFR-mutated non-small cell lung cancer since 2015. As it faces patent expiration, AstraZeneca is extending its lifecycle by testing Tagrisso in earlier disease stages and in combination with next-generation treatments like datopotamab deruxtecan. These strategies aim to sustain its market share post-exclusivity.
6. Brilinta
Disease: Acute coronary syndrome, coronary artery disease, stroke prevention
Company: AstraZeneca
2024 U.S. Sales: $751 million
AstraZeneca’s Brilinta has expanded its reach across multiple indications but never achieved its ambitious $3.5 billion sales target. With generics expected by mid-2025, manufacturers like Sandoz, Dr. Reddy’s, and Torrent Pharmaceuticals are set to enter the market. AstraZeneca has fought patent challenges since 2015, but its exclusivity officially ends in November 2025.
7. Eylea
Disease: Wet age-related macular degeneration, diabetic macular edema, retinal vein occlusion, retinopathy of prematurity, diabetic retinopathy
Company: Regeneron
2024 U.S. Sales: $4.77 billion
Eylea has been a leader in ophthalmology since 2011, but its reign is threatened by biosimilars and Roche’s competing drug, Vabysmo. In late 2024, Amgen’s Pavblu became the first biosimilar to launch, with others from Biocon, Samsung Bioepis, and Sandoz following suit. Legal challenges have delayed some launches, but biosimilar availability will significantly impact Eylea’s revenue trajectory in 2025.
8. Prolia/Xgeva
Disease: Osteoporosis, bone metastases, giant cell tumor of bone
Company: Amgen
2024 U.S. Sales: $4.39 billion
Amgen has been a dominant player in the biosimilar space, but in 2025, it finds itself on the defensive. Prolia (for osteoporosis) and Xgeva (for oncology) will lose exclusivity in mid-2025, opening the door for biosimilar competition. Given their widespread use, analysts predict gradual but steady erosion of sales, mirroring AbbVie’s experience with Humira. Amgen is now focusing on next-generation bone health treatments to cushion the blow.
9. Soliris
Disease: Paroxysmal nocturnal haemoglobinuria, atypical haemolytic uraemic syndrome, generalized myasthenia gravis, neuromyelitis optica spectrum disorder
Company: AstraZeneca
2024 U.S. Sales: $1.52 billion
AstraZeneca’s Soliris, approved in 2007 for PNH, has long dominated the market but now faces threats from biosimilars by Amgen and Samsung Bioepis. AstraZeneca has shifted focus to Ultomiris, which overtook Soliris in sales last year. While biosimilars have gained traction in Europe, the real challenge begins with upcoming U.S. launches, starting with Amgen’s Bkemv in 2025.
10. Tasigna
Disease: Chronic myeloid leukemia
Company: Novartis
2024 U.S. Sales: $848 million
Novartis’ Tasigna, approved in 2007, will lose exclusivity in 2025, triggering generic competition from Apotex, MSN Laboratories, and Hetero Labs. Sales declined 8% in 2024, and with the launch of a reformulated version called Danziten by Azurity Pharmaceuticals, pressure on Tasigna’s market share will intensify. Novartis has preemptively licensed Tasigna generics in 44 territories under a UN initiative.
Conclusion
The loss of exclusivity for these ten blockbuster drugs will significantly reshape the pharmaceutical landscape in 2025. With generics and biosimilars flooding the market, brand-name manufacturers will see sharp revenue declines. However, many are already pivoting to next-generation treatments and lifecycle management strategies to mitigate losses. While competition will drive down drug prices, improving patient access, it also challenges the industry to continue innovating at a rapid pace. The coming year will test the resilience of pharmaceutical giants as they adapt to a shifting market.
Blockbuster Drugs
Blockbuster Drugs
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