Patent expiry refers to the end of the legal protection period granted to a patented invention or product. When a pharmaceutical company develops a new drug, they typically apply for a patent to protect their invention.
Patent expirations are a critical event in the pharmaceutical industry as they often lead to generic competition, which can significantly impact a drug's market share and revenue.
Key Points About Patent Expiry:
Exclusive Rights: During the patent term, the patent holder has exclusive rights to manufacture and sell the drug.
Generic Competition: Other companies are allowed to produce and sell generic versions of the original branded drug.
Market Impact: The introduction of generics after patent expiry usually leads to a significant decrease in the original drug's price and market share.
Revenue Loss: For the original patent holder, patent expiry can result in substantial revenue loss as the market share is taken over by generic competitors.
Strategies to Delay Expiry: Companies may use strategies like "evergreening" (making minor changes to the drug to extend the patent) or litigation to delay generic competition.
Drugs losing patent protection in the next five years
Over the next five years, several high-profile drugs are expected to lose patent protection. Here are some notable examples:
Keytruda (pembrolizumab) – Merck : Keytruda is a blockbuster immunotherapy drug used for treating various cancers.
Patent Expiry: 2028 (with some patents extending to 2035, but key patents will begin expiring in 2028)
Impact: After patent expiry, the drug sales are forecasted at $27.4bn in 2029, a decrease of 19% from $33.7bn in 2028 estimates.
Eliquis (apixaban) - Bristol-Myers Squibb/Pfizer
Patent Expiry: 2027 (U.S.)
Impact: Eliquis is a major revenue driver for both companies, and its patent expiry will likely lead to generic competition, reducing its market share.
Opdivo (nivolumab) - Bristol Myers Squibb
Patent expiry: 2028 (US)
Impact: loss of exclusivity for Opdivo and other cancer medication Revlimid and Pfizer-partnered blood thinner Eliquis within the next few years, the company is likely to launch new drugs, that could contribute over $15 billion in sales.
Ibrance (Palbociclib) - Pfizer
Patent expiration: 2027
Impact: Ibrance, is a medication developed for the treatment of HR-positive and HER2-negative breast cancer. Pfizer may continue to enjoy US exclusivity even after 2027; however, pharma companies continue to develop their own versions.
Xarelto and Eylea (Bayer / J&J)
Patent expiry: 2025 to 2026 (Eylea) & Patent expiry: 2026 (Xarelto)
Impact: In 2022, Xarelto was Bayer’s bestselling pharmaceutical product, bringing in 4.5 million euros worth of revenue. With two of its star drugs, Xarelto and Eylea soon up for expiration, Bayer is opening up new arenas to expand its portfolio specially in the areas of cell and gene therapies.
Prevanar 13 (Pfizer)
Patent expiry: 2026
Impact: The company is investing heavily into R&D pipeline and secured seven FDA nods in 2023 and acquired Seagen Inc. in December 2023 to strengthen its oncology portfolio as a strategy to compensate for the loss due to patent expiry.
Xtandi (enzalutamide) - Pfizer/Astellas
Xtandi is a key drug in the prostate cancer market.
Patent Expiry: 2027 (U.S.)
Revlimid (lenalidomide) - Bristol-Myers Squibb
Patent Expiry: 2022-2027 (Staggered expiries due to settlements with generic manufacturers)
Imbruvica (ibrutinib) - AbbVie/Johnson & Johnson
Patent Expiry: 2027 (U.S.). The last patent of the Imbruvica drug slated to expire in 2036.
Enbrel (etanercept) - Amgen/Pfizer
Patent Expiry: 2029 (U.S.), but biosimilars are expected before due to legal challenges.
Xarelto (rivaroxaban) - Johnson & Johnson/Bayer
Patent Expiry: 2024 (U.S.)
Januvia (sitagliptin) - Merck
Patent Expiry: 2026 (U.S.)
These are some of the many other drugs that are expected to lose patent protection in the coming years, leading to increased generic competition and impacts overall revenue loss to the patent holder and significant shifts in the pharmaceutical market.
Patent expiry is a pivotal event marking the transition from market exclusivity to increased competition. While it often leads to revenue declines for the original patent holders, it also fosters greater access to affordable medications through the introduction of generics and biosimilars. This shift not only challenges pharmaceutical companies to innovate and diversify their portfolios but also benefits patients and healthcare systems by making essential drugs more widely available at lower costs. Ultimately, patent expiry drives the balance between innovation and accessibility in the healthcare landscape.
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