The biopharma industry is bracing for a significant upheaval as many blockbuster drugs approach patent expiration between 2026 and 2029. These treatments are projected to account for approximately $230 billion in annual sales that will be lost due to the end of patent exclusivity. This situation has led to increased merger and acquisition activities as companies scramble to offset the anticipated revenue losses.
The term “patent cliff” first appeared in discussions about the biopharma sector in 2010. The phenomenon was notably highlighted again in 2011 when Lipitor (atorvastatin) lost its foundational U.S. patent protection. A similar concept was described by The Economist in 2009, referring to it as a “looming patent-expiry crisis.” However, the stakes have never been as high as they will be in the coming years, with numerous patents on billion-dollar medications set to expire.
According to research conducted by GEN, the top 20 drugs facing patent expiration are expected to collectively contribute to a staggering $176.442 billion in sales losses. This represents around 75% of the total $236 billion in annual sales projected to vanish due to lost exclusivity.
This ongoing trend is illustrated by recent high-profile acquisitions in the industry. For instance, in April, Johnson & Johnson finalized its acquisition of Intra-Cellular Therapies for $14.6 billion. Merck & Co. completed a $10 billion purchase of Verona Pharma on October 7, aimed at broadening its portfolio in cardio-pulmonary disease treatments. Sanofi also concluded a deal in July, acquiring Blueprint Medicines for up to $9.5 billion to enhance its offerings in rare immunological diseases.
GEN”s analysis lists the top 20 blockbusters poised to lose key U.S. patent protection over the next few years. The drugs are categorized by the year their patents are expected to expire, based on disclosures made by the companies in their regulatory filings.
Specific medications nearing patent expiration include:
- Merck”s Januvia (sitagliptin; $2.255 billion) in 2026
- Pfizer”s Xeljanz (tofacitinib; $1.618 billion) in 2026
- Merck”s Janumet (sitagliptin and metformin hydrochloride; $1.433 billion) in 2026
- Pfizer”s Ibrance (palbociclib; $6.393 billion) in 2027
- Amgen”s Enbrel (etanercept; $5.386 billion) in 2028
- Amgen”s Repatha (evolocumab; $3.574 billion) in 2029
- Gilead Sciences” Genvoya (combination of elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide; $2.503 billion) in 2029
This upcoming wave of patent expirations is expected to reshape the landscape of the biopharma industry, as companies seek innovative ways to adapt to the loss of exclusivity on these lucrative drugs.
