The Patent Countdown: Drugs To Lose Its Exclusivity In Coming Years!

What results in the entry of cheaper and generic versions of medicines into the market? The patent expiry, right?

In the coming years, multiple leading pharmaceutical drugs will lose their patents; the expiry will deliver greater affordability and improved healthcare system access to patients. 

Patent expiry leads to decreased revenue for pharmaceutical companies while they compete against more options. The drugs which have greatly influenced modern healthcare include treatments for diabetes and respiratory diseases and additional vital medical needs. 

Drugmakers should focus on changing their strategies post-exclusivity expiration because they must continuously innovate their therapeutic approaches or collaborate with other pharmaceutical companies. Annually, this transition demonstrates the pharmaceutical industry's progress through its continuous transformation while it maintains equilibrium between new interventional therapies and universal access to vital medicines. 

Merck- Keytruda

• Patent Expiry- 2028
• Sales in 2023 - $25B

Merck & Co.'s most successful cancer immunotherapy drug, Keytruda, will experience patent expiry in 2028, thus enabling the entry of biosimilar replicas. Biosimilars are highly similar versions of biological medicines developed and approved after the original drug's patent expires. Keytruda received regulatory approval in 2014 for cancer treatment across lung, melanoma and lymphoma, helping immune cells detect cancer cells by blocking the PD-1 pathway. Keytruda contributed 40% of Merck’s pharmaceutical revenue during 2023. 

Gilead Sciences- Biktarvy

• Patent Expiry- 2033
• Sales in 2023 - $11.9B

Biktarvy® by Gilead Sciences utilises bictegravir emtricitabine and tenofovir alafenamide in a single daily dose to limit HIV-1 virus activity, thus preventing viral replication after it received FDA approval in 2018. Biktarvy® exists under multiple patents with primary protection extending through October 2027 because of a substantial settlement with ViiV Healthcare, but other patents extend until 2033. Biktarvy® serves as the primary income generator for Gilead Sciences. The approaching expiry of patents for Gilead's products has prompted the company to develop seven new HIV treatment products expected to become commercialised through 2033, paving the way for sustained market dominance.

Novo Nordisk - Ozempic®

• Patent Expiry- 2032
• Sales in 2023 - $18.4B

Novo Nordisk developed Ozempic®, which belongs to injectable prescription medications for type 2 diabetes management and cardiac risk reduction in adults. Ozempic® (semaglutide) from Novo Nordisk has delivered substantial revenue growth to the company after approval. Generic versions of Ozempic® will become available after the key patents protecting this drug expire between 2031 and 2032 in the United States. Novo Nordisk dedicates research funds to developing CagriSema as its new treatment, combining semaglutide with a novel long-acting amylin agonist. 

Sanofi & Regeneron - Dupixent

• Patent Expiry- 2031
• Sales in 2023 - $11.6B

The allergy treatment Dupixent® (dupilumab) was jointly developed between Sanofi and Regeneron Pharmaceuticals for patients dealing with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, and eosinophilic esophagitis. Dupixent received FDA approval in 2017, and since then, it has demonstrated intense market penetration. The drug patents for Dupixent span from 2030 until 2031. Sanofi continues its market dominance through its efforts to seek new indications like COPD along with Dupixent, which has the potential to expand its sales revenues. 

Bristol Myers Squibb & Pfizer — Eliquis 

• Patent Expiry- 2026
• Sales in 2023 - $12.2B

The anticoagulant Eliquis (apixaban) received approval from the FDA in 2012. Bristol Myers Squibb and Pfizer developed this drug to prevent deep vein thrombosis and pulmonary embolism. The pharmaceutical product Eliquis ranked among the five top-selling drugs in 2020. The U.S. patents protecting Eliquis (apixaban) will end between 2026 and 2027, which leads to anticipated generic market entry in April 2028. European significant markets will see patent expiration for Eliquis occur during the second half of 2026. Under Medicare, the U.S. government secured discounted Eliquis prices, effective in 2026. 

 Eli Lilly - Trulicity

• Patent Expiry- 2027
• Sales in 2023 - $7.1B

Trulicity, an injectable drug by Eli Lilly to treat Type 2 diabetes patients, controls their condition as well as decreases cardiovascular risks for adults. The extended compound patent protection until 2027 allowed Trulicity to develop into one of the key revenue sources for the company, and it became the world's 17th top-selling pharmaceutical in 2023. Mounjaro (tirzepatide), currently developed by Eli Lilly, serves as the foundation for substantial diabetes drug business growth in the next decade, promising significant revenue growth. 

Bristol Myers Squibb - Opdivo

• Patent Expiry- 2028
• Sales in 2023 - $9.0B

Opdivo (nivolumab), produced by Bristol Myers Squibb, operates as an immunotherapy medication for the treatment of melanoma, non-small cell lung cancer and renal cell carcinoma. The 2023 sales revenue from Opdivo totalled $9 billion, and analysts expect the drug to reach $11.75 billion by 2026. Opdivo’s U.S. patent expiration occurs in 2028. The approval of new indications has accelerated Opdivo's market expansion throughout recent years, promising a bright future for the pharmaceutical industry. 

Johnson & Johnson - Darzalex 

• Patent Expiry- 2035
• Sales in 2023 - $9.7B

Darzalex (daratumumab), produced by Johnson & Johnson, operates as an injectable monoclonal antibody that treats multiple myeloma blood cancer patients. The 2023 sales performance of Darzalex reached $9.7 billion while showing a 22% increase from its previous year's revenue.  Darzalex's U.S. patent expires in 2027, yet several others prolong its exclusive protection until 2035. 

Merck - Gardasil 

• Patent Expiry- 2028
• Sales in 2023 - $8.9B

The vaccine Gardasil by Merck defends people against human papillomavirus (HPV) that results in different cancers, especially cervical cancer. The sales generated by the Gardasil vaccine demonstrated a 47% growth over the preceding year. The U.S. patent for Gardasil has an upcoming expiration date in 2028, and extra patent protections will remain exclusive until 2040.  Gardasil sales at Merck experienced difficulties when the company experienced significant cuts to its China-based distribution in quarter 2 of 2024.

AbbVie - Skyrizi

• Patent Expiry- 2033
• Sales in 2023 - $7.8B

Skyrizi (risankizumab-rzaa), provided by AbbVie, serves as an immunology drug to treat moderate to severe plaque psoriasis and active psoriatic arthritis as well as mild to severe Crohn's disease. Since 2019, the drug has gained market success. AbbVie predicts Skyrizi will reach $20 billion in 2027, with $12.5 billion from psoriatic arthritis patients. The basic Skyrizi patent remains valid until 2033, which secures market extension for AbbVie Corporation. 

Conclusion 

The end of pharmaceutical patents is also a turning point for patients and drug companies. Patent loss of big blockbusters Keytruda, Eliquis, Trulicity, Opdivo, and Gardasil will shift treatments to more affordable options through generic or biosimilar choices. Ozempic, Dupixent, and Skyrizi will not lose exclusivity for some more time, but the revenues will keep rolling into their manufacturers' coffers. This shift, which saves patients money, challenges pharmaceutical giants to innovate, expand indications, and develop new therapies. Thus, while affordability for older drugs becomes a priority, innovative treatments keep emerging to continue improving healthcare worldwide.