As we move through 2026 towards 2030, the pharmaceutical industry is no longer approaching the ‘super cliff’ but has already stepped off the edge and is part way down it.
This cliff will see many best-selling drugs in key jurisdictions come off-patent, thus opening up the generic market while creating an annual revenue hole for innovative pharma estimated at between $200 billion and $350 billion. This hole is nearly three times larger than that caused by the 2012-2016 patent expiry cycle.
We are now seeing the immediate impact of the first major wave. For example, the patent covering Novo Nordisk’s semaglutide, the world’s second-best selling prescription medicine, sold as Ozempic® (an injectable for type 2 diabetes), Wegovy® (an injectable for weight loss) and Rybelsus® (a pill for type 2 diabetes) expired in March 2026 in many countries including India and China (in the US, patent extensions move this to 2031) and with combined sales reported at $31 billion in 2025 and growing annually at 40%, this is, depending on your perspective, a seismic revenue gap for innovators to plug or a huge target for generic manufacturers.
The 2026 wave also includes the expiry of patents covering:
- Bristol Myers Squibb and Pfizer’s Eliquis®, known generically as apixaban, a leading direct, oral anticoagulant – the original compound patent is set to expire in November 2026 although a complex patent thicket may mitigate against this and settlements with generic manufacturers have pushed the earliest potential generic entry in the US to April 2028;
- AbbVie and Johnson & Johnson’s Imbruvica®, known generically as ibrutinib, for the treatment of certain cancers including mantle cell lymphoma and chronic lymphocytic leukaemia – primary patents are set to expire in December 2026 with secondary patents to formulations, delivery, polymorphs, methods of use and dosing extending this to 2031-2036; and
- Merck & Co’s Januvia®, known generically as sitagliptin, a dipeptidyl peptidase-4 inhibitor used to lower blood sugar levels in adults with type 2 diabetes – the sitagliptin dihydrogen phosphate salt patent is set to expire in November 2026 (with paediatric exclusivity until May 2027).
It is this backdrop that is driving a critical shift in how ‘Big Pharma’ operate. Whilst the 2012 cliff was about volume and defined by small molecular drugs being replaced by cheap generics, the current cliff has a focus on value and complexity. For example, patent thicket strategies are being effectively deployed to delay generic entry after primary patent expiry and a pivot from small molecules to complex biosimilars is likely to transform the cliff to a biosimilar slope.
This is best illustrated for Merck’s Keytruda®, known generically as pembrolizumab, a humanized monoclonal antibody that inhibits the PD-1 pathway inhibitor triggering immune system T cells to find and kill cancer cells. Merck is depending on manufacturing complexity, regulatory hurdles as well as patent thickets to prevent a sudden loss of its roughly $25 billion in annual revenue when its primary patents expire in 2028.
What does this mean for innovators?
Ultimately, this super cliff underscores the need for innovators to have complex patent portfolio strategies, as part of a sophisticated intellectual property framework, layering strong primary patent protection with secondary patents on formulations, dosages and manufacturing methods to create formidable patent thickets.
For generics, proactive prior art searching to invalidate patents and skinny labelling may allow navigation through such thickets and, for biosimilars in particular, there may be more of a focus on high-value targets that allow for gradually increasing returns against the slope.
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