Patents reward drugmakers for their inventions and, effectively, the large sums of money they invest in research and development. The legal monopoly that patents provide keeps generic copies at bay for many years, even decades, and allows pharmaceutical companies to set higher prices than they otherwise could.

Executive decisions are often closely linked to the patent life of blockbuster medicines. Ahead of so-called patent cliffs, when patent expirations permit waves of lookalike competitors to enter the market, companies typically seek to restock their pipelines by investing in R&D, licensing experimental therapies or acquiring other drugmakers.

A major patent cliff faces the pharma industry later this decade, putting more than $200 billion in annual revenue at risk through 2030. This will force companies into major decisions: Will they pour more money into research? Or will they buy their way out of trouble? 

Below, BioPharma Dive has compiled upcoming expiration dates for the key patents protecting the 30 top-selling drugs, by 2023 sales. We’ll be updating this database as the relevant dates and products change. If we’ve missed anything, or there’s any additional information you’d like to see, please reach out and let us know.

Big pharma's looming patent cliff

Years of expiration for principal patents protecting the top 30 pharmaceutical products by 2023 sales.

The standard term for patents granted in the U.S. is 20 years. Drugmakers usually will have already secured patents on a new drug ahead of any regulatory approval, meaning the protected time on market can be less.

There are strategies to offset this, however, as companies can piece together different forms of regulatory exclusivity, seek what’s known as patent term restoration or create “thickets” of various patents on everything from a dosing schedule to an injection device. 

These thickets — now the target of government scrutiny in the U.S. — can sometimes stave off generic competition for two decades or more. Enbrel, an inflammatory disease drug sold by Amgen, will have enjoyed more than 30 years of protected time on market when a key patent expires in 2029, for example. 

Top-sellers' long-lived patent protection

Lines show length of market monopoly, beginning from first U.S. approval to currently expected patent expiration.


For this database, BioPharma Dive compiled the 30 best-selling drugs by global sales in 2023, then searched their manufacturers’ regulatory filings for disclosures on the expirations of patents and other forms of legal market exclusivity. Typically, this was via the Form 10-K that companies file with the Securities and Exchange Commission.

This database isn’t a comprehensive account of all the patents protecting a branded drug. Rather, it reflects company expectations, as of Dec. 31, 2023, of when competition will arrive in the U.S. or European markets as a result of a primary patent expiring. 

Often the intellectual property in question is what’s known as a “composition of matter” patent, which relates to a drug’s core ingredient and offers the broadest protection. When multiple patents with multiple expiration dates were listed, BioPharma Dive used the composition of matter patent’s expiry date.

Companies can file for patent term extensions in the U.S., or what are known as supplementary protection certificates in the EU. Where those are relevant, BioPharma Dive has used those dates.

This database also doesn’t capture the potential for court rulings, or additional formulation, manufacturing or other patents that could extend market exclusivity. BioPharma Dive will update the database to account for those events as they occur.

When companies reported in currencies other than U.S. dollars, BioPharma Dive converted using yearly average currency exchange rates listed by the U.S. Internal Revenue Service.

BioPharma Dive will annually refresh the list of 30 drugs based on the prior year’s sales.