The idea of a “patent cliff” wave of exclusivity expirations shaking up the biopharma industry isn’t new: GEN first mentions the term in 2010 and again a year later when Lipitor (atorvastatin) lost its basic U.S. patent protection. The Economist used the phrase as early as 2009, a year after describing the phenomenon less deftly as a “looming patent-expiry crisis.”
However, the proverbial cliff has never loomed as large over biopharma as it will over the remainder of this decade, as key patents are set to expire on billion-dollar-plus “blockbuster” drugs generating approximately $230 billion in annual sales between this year and 2030.
The scramble by biopharmas to recoup the revenues to be lost as blockbusters and less lucrative drugs lose exclusivity helps explain a recent surge of mergers-and-acquisitions activity. The top three deals at deadline:
Shown is GEN’s first-ever A-List of top 20 blockbusters set to lose the protection of key U.S. patents—five drugs for each year between 2026 and 2029, ranked by their total revenue for the first half of this year and all of 2024 (as furnished by the companies in regulatory filings and/or press releases).
Drugs are grouped by year based on what companies disclosed as the year of expiration for their patent family or key patents, as stated in annual reports also filed with regulators. Each drug is listed by its trade and generic names, the company or companies that market the treatment, the year of initial U.S. approval, and revenue.
GEN’s research found that the top 20 drugs heading for the patent cliff accounted for a combined $176.442 billion in sales last year—75% of the $236 billion in annual sales set to disappear with the loss of exclusivity, a combined sales figure widely quoted by biopharma market watchers that includes Deloitte and EY.
Also found were numerous additional drugs whose patents are set to expire between 2026 and 2029:
- 2026: Merck’s Januvia® (sitagliptin; $2.255 billion); Pfizer’s Xeljanz® (tofacitinib, $1.618 billion); and Merck’s Janumet® and its extended-release version Janumet® XR (sitagliptin and metformin hydrochloride, $1.433 billion).
- 2027: Pfizer’s Ibrance® (palbociclib; $6.393 billion).
- 2028: Amgen and Pfizer’s Enbrel® (etanercept; $5.386 billion).
- 2029: Amgen’s Repatha® (evolocumab; $3.574 billion); Gilead Sciences’ Genvoya® (elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide; $2.503 billion).
See all the recent A-Lists GENengnews.com/A-lists.
