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:
- Johnson & Johnson in April closed this year’s largest acquisition at deadline, its $14.6 billion buyout of Intra-Cellular Therapies, a neurological drug developer.
- Merck & Co. on October 7 completed its $10 billion purchase of Verona Pharma, a deal designed to expand the pharma giant’s pipeline and portfolio of cardio-pulmonary disease treatments.
- Sanofi in July closed on its up-to-$9.5 billion acquisition of Blueprint Medicines, a deal intended to expand the buyer’s rare immunological disease portfolio.
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).
References
1. Revenue is for the entire family of Prevnar products, which includes Prevnar 20®/ Apexxnar (pediatric and adult) as well as Prevnar 13/Prevenar 13 (pediatric and adult).
2. While some companies have marketed generic versions of lenalidomide, they are sold pursuant to volume-limited licenses granted under litigation settlements. Effective January 31, 2026, those licenses will no longer be volume-limited.
3. Eisai co-markets Lenvima with Merck & Co., which reports its revenue figures for the drug as “alliance” revenue representing its share of profits, which are product sales net of cost of sales and commercialization costs.
4. According to Regeneron’s Form 10-K annual report for 2024, patents for Eylea expire between 2027 and 2039, starting with four formulation patents expiring on June 14, 2027. Patents for Eylea HD expire between 2027 and 2032, starting with two formulation patents expiring on June 14, 2027.
5. Pfizer says its reported revenues primarily reflect alliance revenues and royalty revenues. The company receives tiered royalties as a percentage of international Xtandi net sales. Astellas has exclusive commercialization rights for Xtandi outside the U.S.
6. Lynparza, co-marketed by AstraZeneca and Merck, is eligible for six months of pediatric market exclusivity (with pending PTE). Merck records revenues as Alliance Revenue representing Merck’s share of profits, which are product sales net of cost of sales and commercialization costs.
7. The compound patent family contains two additional patents that expire in 2029 due to patent term adjustment resulting from patent office delay. Merck says these patents are based on the initial discovery of the active ingredient in Keytruda.
8. Merck reports combined revenues for Gardasil and Gardasil 9.
9. Novartis licenses the drug from Incyte outside the U.S. under the name Jakavi® for use in hematology and oncology, excluding topical administration.
10. Lilly records sales for the entire Jardiance family of treatments, which includes Glyxambi, Synjardy, and Trijardy XR.
11. J&J reports combined sales figures for Darzalex and Darzalex Faspro. Genmab owns two patent families related to Darzalex, with Janssen Biotech holding an exclusive license to those patent families, which expire in the U.S. in 2029. J&J’s Janssen Biotech. owns a separate patent portfolio related to Darzalex Faspro.
See all the recent A-Lists GENengnews.com/A-lists.
