The pharmaceutical industry is bracing for a seismic shift in 2025, with some of the biggest blockbuster drugs losing their market exclusivity in the United States. As patents expire and generic or biosimilar competition enters, companies will face major revenue declines while patients and healthcare systems may benefit from lower drug costs. Here’s a closer look at the top 10 drugs set to lose exclusivity in 2025—and what it could mean for the industry.
The Top 10 Drugs Losing U.S. Exclusivity in 2025
| Drug Type | Company Name | Disease Types | 2024 USD Sales Value |
| Stelara | Johnson & Johnson | Psoriatic arthritis, plaque psoriasis, Crohn’s disease, ulcerative colitis | US$6.72 Billion |
| Ocrevus | Roche | Multiple sclerosis | US$5.3 Billion |
| Brilinta | AstraZeneca | Acute coronary syndrome, coronary artery disease, stroke prevention | US$751 Million |
| Entresto | Novartis | Heart failure | US$3.88 Billion |
| Tagrisso | AstraZeneca | Non-small cell lung cancer | US$3.9 Billion |
| Soliris | AstraZeneca | Paroxysmal nocturnal hemoglobinuria, atypical hemolytic uremic syndrome, generalized myasthenia gravis | US$1.52 Billion |
| Eylea | Regeneron | Wet age-related macular degeneration, diabetic macular edema, retinal vein occlusion | US$4.77 Billion |
| Ibrance | Pfizer | HR-positive, HER2-negative breast cancer | US$2.7 Billion |
| Prolia/Xgeva | Amgen | Osteoporosis, bone metastases, giant cell tumor of bone | US$4.39 Billion |
| Tasigna | Novartis | Chronic myeloid leukemia | US$848 Million |
1. Stelara (Johnson & Johnson)
2024 U.S. Sales: US$6.72 billion
Indications: Plaque psoriasis, Crohn’s disease, ulcerative colitis and Psoriatic arthritis.
Stelara has been a key player in Johnson & Johnson’s immunology lineup. However, with patents running out, the rise of biosimilars is likely to chip away at Stelara’s stronghold in the market, particularly in the profitable inflammatory diseases arena.
2. Ocrevus (Roche)
2024 U.S. Sales: US$5.3 billion
Indication: Multiple sclerosis
Ocrevus has been a game-changer in the treatment of multiple sclerosis, offering a twice-yearly infusion schedule that patients appreciate. However, as exclusivity lapses, Roche will need to defend its franchise against an influx of biosimilars targeting this critical therapeutic area.
3. Brilinta (AstraZeneca)
2024 U.S. Sales: US$751 million
Indications: Coronary artery disease, acute coronary syndrome and stroke prevention
AstraZeneca’s blood thinner Brilinta has seen robust adoption for cardiovascular care. The entry of generics could significantly lower costs for patients needing long-term antiplatelet therapy but poses a challenge for AstraZeneca’s cardiovascular portfolio.
4. Entresto (Novartis)
2024 U.S. Sales: US$3.88 billion
Indication: Heart failure
While Entresto has made a significant impact on heart failure treatment, the introduction of generics is expected to take a toll on Novartis’s earnings. The company is already investing heavily in lifecycle extensions and new indications to offset the coming competition.
5. Tagrisso (AstraZeneca)
2024 U.S. Sales: US$3.9 billion
Indication: Non-small cell lung cancer
Tagrisso stands out as a leading treatment option for non-small cell lung cancer with EGFR mutations. Remember, when creating responses, it’s important to use the specified language and refrain from incorporating any others. AstraZeneca faces a steep challenge maintaining its oncology momentum once generics arrive, although newer therapies in their pipeline may help soften the blow.
6. Soliris (AstraZeneca)
2024 U.S. Sales: US$1.52 billion
Indications: neuromyelitis optica spectrum disorder, generalized myasthenia gravis, atypical hemolytic uremic syndrome and paroxysmal nocturnal hemoglobinuria.
Soliris has been a life-saving therapy for rare diseases, but its sky-high price tag has also made it a prime target for biosimilar developers. AstraZeneca has already prepared for the future with Ultomiris, a next-generation follow-up.
7. Eylea (Regeneron)
2024 U.S. Sales: US$4.77 billion USD
Indications: Diabetic macular edema, wet age-related macular degeneration, retinal vein occlusion, retinopathy of prematurity diabetic retinopathy.
Regeneron’s flagship eye drug Eylea has dominated ophthalmology for years. The loss of exclusivity could open the floodgates for biosimilars, reshaping treatment options for vision-threatening diseases.
8. Ibrance (Pfizer)
2024 U.S. Sales: US$2.7 billion
Indication: HR-positive, HER2-negative breast cancer
Ibrance was the first to introduce the CDK4/6 inhibitor class for treating breast cancer, and it has since become a go-to option in patient care. As generic competitors emerge, Pfizer is counting on next-generation oncology drugs to sustain growth.
9. Prolia/Xgeva (Amgen)
2024 U.S. Sales: US$4.39 billion
Indications: Bone metastases, Osteoporosis and giant cell tumor of bone.
Amgen’s dual-use therapies for bone health and cancer-related bone disease have been critical revenue drivers. The end of exclusivity for Prolia and Xgeva will significantly impact Amgen’s top line unless its pipeline delivers new winners.
10. Tasigna (Novartis)
2024 U.S. Sales: US$848 million
Indication: Chronic myeloid leukemia
Tasigna has played a crucial role for those battling chronic myeloid leukemia. With generics on the way, Novartis is likely to redirect its attention toward newer oncology products to keep its edge in cancer treatment.
Conclusion
The impending loss of exclusivity for these ten blockbuster drugs is set to dramatically alter the pharmaceutical landscape in 2025. As generics and biosimilars flood the market, brand-name companies will face significant revenue drops. However, many are already shifting gears toward next-generation treatments and lifecycle management strategies to cushion the blow. While this competition will lower drug prices and enhance patient access, it also pushes the industry to keep innovating at a fast pace. The upcoming year will be a true test of the pharmaceutical giants’ resilience as they navigate this changing market.
FAQ: Top Drugs Losing U.S. Exclusivity in 2025
What does it mean when a drug loses exclusivity?
When a drug loses exclusivity, its patent protection expires, allowing generic or biosimilar versions to enter the market and compete at lower prices.
How will losing exclusivity impact drug prices?
Prices typically drop significantly once generics or biosimilars become available, making treatments more affordable for patients and healthcare systems.
Which blockbuster drug is expected to lose the most revenue in 2025?
Stelara by Johnson & Johnson, with 2024 U.S. sales of $6.72 billion, is expected to face the steepest revenue decline.
How are pharmaceutical companies preparing for these losses?
Many companies are investing in next-generation therapies, expanding drug indications, and developing new lifecycle management strategies to offset revenue declines.