Patents for multiple blockbuster drugs are set to expire!
01
Reorganization of Chronic Disease Medication
In the next three years, next-generation blockbuster drugs in the metabolic and cardiovascular fields—such as GLP-1 receptor agonists, SGLT2 inhibitors, and PCSK9 inhibitors—will successively face patent cliffs, potentially triggering a new wave of generic drug development for chronic disease medications.
The GLP-1 receptor agonist semaglutide has achieved explosive sales growth in recent years due to its breakthrough efficacy in weight loss and glycemic control. In 2024 and 2025, the combined sales of its three brands reached 200 billion yuan and 250 billion yuan, respectively.
However, the patent cliff for semaglutide is approaching.
In Canada, the patent for semaglutide expired on January 4, 2026, and the patent protection in the China market will also expire in March 2026.
Global generic drug manufacturers are poised to capture a share of this $100 billion market.
Pharmaceutical Intelligence data indicates that over a dozen biosimilars of semaglutide have been submitted for market approval globally, including global generic drug giants such as Sandoz and Teva, as well as domestic pharmaceutical companies like GenScript, Livzon Group, Qilu Pharmaceutical, Federal Pharmaceutical, Huadong Medicine, and Zhengda Tianqing, along with the improved new drug from CSPC Pharmaceutical Group.
However, in the U.S. market, Novo Nordisk successfully extended the core patent for semaglutide from 2026 to 2031, buying more time for this blockbuster drug.
SGLT2 inhibitors are also facing a shakeout.
Jardiance (enalapril) tablets, developed by Boehringer Ingelheim and co-promoted by Eli Lilly, has emerged as a star drug in chronic disease treatment due to its unique glucose-lowering mechanism and expanded indications in heart failure and chronic kidney disease. In 2024, the drug achieved sales of nearly 90 billion yuan.
According to the Drug Intelligence Data-Patent Expiration Drug Screening System, the patent for empagliflozin in the United States will expire gradually in 2027, with the latest patent protection period extending to 2034.
In China, the fate of this drug was even more tragic, as its core compound patents were declared invalid in 2020. To date, 43 domestic companies have been approved to produce enalapril maleate tablets, including leading pharmaceutical firms such as Hansoh Pharmaceutical, Kelun Pharmaceutical, and CP Group.
AstraZeneca's SGLT2 inhibitor dapagliflozin (Farxiga/Andagliflozin) achieved sales exceeding 50 billion yuan in 2024, maintaining its position as the company's best-selling drug.
The compound patent of this drug in China expired in May 2023, and there are already many generic drugs on the market domestically. However, the crystal form patent remains a major obstacle for some generic drugs to enter the market, and this patent will expire in June 2027.
Additionally, the compound patent for dapagliflozin in the United States will expire in 2026.
Novartis is no exception.
Its blockbuster cardiovascular drug sacubitril/valsartan sodium tablets (Entresto/Noxent) lost its U.S. patent in July 2025, and China's core patent will expire in 2026. Currently, generic versions from 33 domestic pharmaceutical companies have passed consistency evaluations, awaiting to share the market share of this blockbuster drug.
Among the small-molecule blockbuster drugs with patents expiring in the next three years is BMS/Pfizer's anticoagulant apixaban (Eliquis).
This drug is a coagulation factor Xa inhibitor, indicated for reducing stroke risk in patients with non-valvular atrial fibrillation (AF), as well as for the treatment and prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE). Its annual sales have exceeded 100 billion yuan for consecutive years.
The patent for apixaban in the United States will expire in 2026. The FDA has approved generic drug applications from companies such as Mylan, Micro Labs, and Huahai Pharmaceutical.https://www.jxserum.com/pharmaceutical-products/ However, BMS/Pfizer had previously reached an agreement with generic drug manufacturers to delay the market launch of the generic version until 2027.
In China, the compound patent for apixaban was invalidated in 2019, and domestic generic drugs quickly followed up, with more than 40 having passed the consistency evaluation.
02
Power Transition in Oncology and Autoimmunity Fields
Enzalutamide (Xtandi) has been the cornerstone drug for prostate cancer treatment over the past decade, but its core patent protection is nearing expiratio
This drug is a second-generation androgen receptor (AR) inhibitor, with global sales reaching 57.8 billion yuan in 2024.
Its compound patents in China and the United States will expire in 2026. Previously, in 2025, Xuantai Pharmaceutical's enzalutamide tablets had received temporary approval from the U.S. FDA. In China, several pharmaceutical companies, including Qilu Pharmaceutical, Hansoh Pharmaceutical, CP Group, and Kelun Pharmaceutical, have also had their enzalutamide soft capsules and tablets approved for market release.
Meanwhile, next-generation AR inhibitors have become a focal point in the competition among innovative pharmaceutical companies, including Bayer's darotamide tablets and Haisun Pharmaceutical's deuterated enzalutamide soft capsules.
Imbruvica (Ibrutinib) is the world's first approved BTK inhibitor, enabling patients with certain hematologic malignancies such as chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL) to forgo chemotherapy and enter the era of targeted therapy.
The compound patent of the drug in China will expire at the end of 2026, and the core compound patent in the United States will expire in 2027.
Currently, generic versions of ibrutinib have been approved in China by Simcere Pharmaceutical, Qidu Pharmaceutical, Corei Pharmaceutical, Huadong Medicine, and Zhengda Tianqing, with the potential for rapid market entry after patent expiration.
Notably, following ibrutinib, second-generation BTK inhibitors have emerged as the dominant players in the market, with zanubrutinib and acrutinib experiencing rapid market share growth.
Additionally, Eli Lilly's third-generation covalent BTK inhibitor Pirtobrutinib was approved for marketing in 2023; Lopinbo (Lopinib) Tablets, a fourth-generation covalent and non-covalent BTK inhibitor developed by Lopinbo Pharmaceuticals, has submitted a marketing application and is expected to receive approval in the near future for the treatment of adult mantle cell lymphoma patients who have previously received BTK inhibitor therapy.
In the autoimmune field, numerous established products are also poised to face market restructuring due to patent cliff.
Secukinumab is the world's first approved IL-17A inhibitor, which has long dominated the psoriasis market. Its global sales exceeded 40 billion yuan in 2024.
The domestic core patent of this drug will expire in 2025, and other patents will also expire in the coming years.
According to Pharma Intelligence data, no biosimilar of this drug has been approved globally at present. However, Bio-Thera's BAT2306 has submitted its marketing application in February 2025, and the company is actively preparing to submit applications to the U.S. FDA and the European EMA.
Additionally, three domestically developed IL-17 monoclonal antibodies—Fuzanishizumab by Hengrui, Sereqizumab by Zhixiang Jintai, and Anmuzhitamab by Sansheng Guojian—have been approved for market release, establishing a new competitive force in the field.
Another blockbuster autoimmune drug by Novartis, rucelitinib phosphate, is also facing a patent cliff.
The drug is the world's first approved JAK inhibitor, which has been on a strong upward trajectory since its launch, with sales reaching approximately 40 billion yuan in 2024. Its patent in China will expire in 2028.
Currently, generic versions of ruxolitinib phosphate tablets have been approved for Chengdu Yuandong Biotechnology, Jiangxi Kerui Pharmaceutical, Nanjing Zhengke Pharmaceutical, Shandong New Era Pharmaceutical, and Kunshan Longdeng Ruidi Pharmaceutical.
03 peroration
In the coming years, a significant number of blockbuster drug patents will expire, presenting opportunities for generic and biosimilar manufacturers. However, originator drug companies are not passive. On one hand, they are extending the lifecycle of their products by developing new dosage forms and indications. On the other hand, they are positioning themselves to take over these products through in-house R&D or acquisitions, thereby reshaping competitive barriers in their core domains. For patients, this may mark the long-awaited moment of price reductions, leading to more diverse and accessible treatment options.https://www.jxserum.com/pharmaceutical-products/