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Over the next five years, several blockbuster oncology drugs from leading pharmaceutical companies will lose patent protection, ushering in a wave of patent cliffs that pose significant revenue and strategic risks. This concentrated wave of oncology losses of exclusivity (LOEs) stems from a historic surge in immuno-oncology approvals during the mid-2010s, particularly in checkpoint inhibitors and targeted therapies. Many of these blockbuster assetslaunched between 2014 and 2017were granted expedited pathways, bringing them to market faster but also aligning their exclusivity periods. These cliffs, historically associated with revenue drops that can exceed 50% within two years of LOE, present a critical inflection point, especially for sponsors heavily reliant on a few oncology assets [1].What happens when the cliff hits? The historical signalsHistorical signals from Avastin, Gleevec and Revlimid, illustrate the disruptive nature of such events. Each saw rapid revenue declinesAvastin dropped over 40% post biosimilar entry, Gleevec lost more than 50% of U.S. sales within a year of generic launch, and Revlimid faced a projected 50% erosion despite staggered generic entryunderscoring the urgent need for proactive lifecycle and pipeline strategies [1,2]. Sponsors unprepared for the transition faced valuation declines, market share loss and delayed R&D pivots, either in the reprioritization of promising clinical assets or in investing in registrational-stage ones. Conversely, sponsors with diversified pipelines or aggressive acquisition strategies managed to absorb the impact and maintain momentum. Oncology, due to its high-value therapies and pricing premiums, is particularly vulnerable to erosion once biosimilar and generic competition enters the scene. We took a closer look at the waters ahead to understand how well-positioned companies are to navigate the looming patent cliffs. Drugs like Keytruda, Opdivo and Darzalex approaching LOE represent tens of billions in annual revenue at risk. While some companies have fortified pipelines or pursued lifecycle management strategies, others remain overexposed or delayed in their planning. This snapshot aims to highlight strategic posture as of today, while recognizing that these positions are dynamicand that sponsors still have time to improve their trajectories.Oncology LOE risk and readiness lensTo better understand which companies are strategically positioned to weather the impact of oncology patent cliffs, we developed a readiness framework that assesses both impact exposure and pipeline momentum. The framework incorporates two metrics:An Impact Absorption Score, which evaluates how dependent a company is on a soon-to-expire drug and whether it maintains a broader commercial presence in oncology; and A Clinical Launch Momentum Score, which measures the strength of a company's near-term clinical oncology portfolio, especially the number of late-stage assets with a high likelihood of approval.To complement these, we included a Revenue at Risk metricreflected in the bubble size on the accompanying chartcapturing the absolute dollar value of oncology revenue exposed to LOE. This provides an at-a-glance sense of the potential financial magnitude each company must contend with as they approach key cliff events.Permission granted by Intelligencia AIFrom our perspective at Intelligencia AIthrough access to a comprehensive clinical trial database and regular analysis of the competitive positioning of pharma pipelinesthe current snapshot of patent cliffexposed companies comes as little surprise. We've seen early signals across trial activity, pipeline robustness, and business development behavior. For instance, weve observed that sponsors with consistently high trial initiation rates in post-LOE indications, coupled with targeted in-licensing of late-stage assets, tend to rank higher in readinesspatterns we've seen reflected in companies like Merck Sharp & Dohme (MSD). At the same time, companies with fewer late-stage trials and limited BD&L activity in oncology subtypes where exclusivity is expiring may face a more challenging transition unless strategic adjustments are made. By continuously integrating clinical data in real time with deal flow analytics, sponsors can improve situational awareness and act well before cliff-side impacts become visible in earnings.Our analysis, represented in the graph above, highlights both existing strengths and areas where renewed focus may be required. Some companies already show strong signs of preparation, while others have the opportunity to enhance their resilience through targeted action.Facing the cliff: Whos ready to leap, and whos looking down? To bring this framework to life, we highlight three illustrative sponsorseach occupying a distinct quadrant:Genentech (Roche): Safe harborsPositioned in the upper right quadrant, Genentech combines strong momentum with the ability to absorb impactmaking it a clear example of a Safe Harbor. Despite facing near-term LOEs for Kadcyla and Perjeta, Genentech retains exclusivity for more than fifteen oncology therapies. Notably, almost half of its pipeline has progressed to late-stage development, supporting future revenue continuity. Its relatively balanced revenue distribution across assets limits vulnerability, reducing the size of its Revenue at Risk bubble despite upcoming expiries. Astellas: Storm frontIn the lower left quadrant, Astellas exemplifies the Storm Frontlow absorption capacity paired with limited momentum. With Xtandi approaching LOE and few other oncology products or late-stage candidates to offset the loss, Astellas faces concentrated risk with little in the near-term pipeline to relieve pressure. Its Revenue at Risk is moderate in absolute terms but highly concentrated, amplifying its strategic vulnerability. The window for action remains open, but its narrowing.MSD: Rising tidesMSD is a classic example of a Rising Tidea company with strong clinical momentum but high exposure to a single anchor product. With Keytruda accounting for nearly half of its oncology revenue, MSD carries one of the largest Revenue at Risk profiles in the landscape. However, the company has taken deliberate steps to accelerate its pipeline, with multiple late-stage assets progressing toward approval. This momentum signals a clear effort to offset future erosion and positions MSD to ride the tide of clinical progress, even as it faces a sharp LOE drop from a heavily concentrated revenue base. From Analysis to actionable strategy: Staying ahead of the oncology patent cliffThe oncology patent cliff presents a complex and urgent challenge. As blockbuster therapies approach loss of exclusivity, the consequences for unprepared sponsors can be steepranging from sharp revenue erosion to delayed R&D pivots and weakened market positions. But while the risks are significant, the window for action remains open.Companies best positioned to weather the cliff are those that actively invest in late-stage pipelines, accelerate clinical execution, and pursue external innovation with a sense of urgency. This challenge touches all parts of the organization. Portfolio strategy leaders must reassess timelines and resource allocations with LOE pressure in mind. Search & evaluation teams are racing to identify high-fit external assets amid fierce competition. And BD&L professionals must act decisively to close value-driving deals before the window narrows.This current snapshot reflects where companies stand today, not where they ultimately need to be. Strategic posture in this environment is inherently dynamic. Companies can still shift course by reprioritizing clinical assets, tightening portfolio governance, identifying whitespace for in-licensing, and building partnerships that close therapeutic or modality gaps. Success will hinge on the ability to translate pipeline and market foresight into coordinated, data-driven action.At Intelligencia AI, we equip sponsors to do exactly that drive smarter decisions with the right data, insights and AI. Our solution brings together predictive analytics, clinical data in real-time, and business development intelligence to help teams evaluate risk precisely, monitor competitive activity continuously, and uncover strategic opportunities earlybefore cliff-side impacts appear in earnings.The patent cliff is real and fast approachingbut its outcome is not yet written. For those willing to act decisively, there is still time not only to mitigate the fallout but to emerge stronger, more focused, and better positioned for the next era of oncology innovation.ReferencesKim, M. S., Haslam, A., & Prasad, V. (2025). Trend of sales revenue by year for top-selling cancer drugs in the US and the effect of loss of market exclusivity. Journal of Cancer Policy, 43, 100533. https://doi-org.libproxy1.nus.edu.sg/10.1016/j.jcpo.2024.100533FirstWord Pharma. (2021, April 21). Roche confirms outlook despite drug sales falling 14% in Q1. Retrieved from https://firstwordpharma.com/story/5279321 '

New Delhi: Ahmedabad based drugmaker Zydus Lifesciences is progressing to introduce market-specific dosage strengths of its Semaglutide formulations, expected to be launched over the next 1 to 2 years time, said Dr Sharvil Patel, MD, Zydus Lifesciences Ltd. Speaking at the company’s Q1 FY26 earnings call, Dr Sharvil Patel said, “along with India, we will take our formulations to other markets and our strategy is to enter with not the same but differentiated formulations across all markets and regulatory filings will begin by the end of the year, and we expect product launches within 1–2 years, depending on the duration of the approval process.” “We are quite excited with our novel formulation which offers significant benefit versus the existing formulation in the market and from the commercialisation point of view India will generate the highest revenue for us,” he added. Commenting on the capacity to meet demand in Canada and India, where the market is expected to open by March, the MD said, “The company has sufficient capacity and alternate sources, and the device (pen) is also planned.” “We are fully integrated to offer both backward–API and forward–finished formulation,” he noted. Notably, earlier reported by the Economic Times, Zydus has been working on a pen device which can deliver “adjustable doses”, thereby potentially eliminating the requirement of separate pens. Semaglutide, marketed by Danish drugmaker Novo Nordisk under the brand name Wegovy for weight-loss and Ozempic for type-2 diabetes is available as a prefilled pen where each pen is for one-time use only and comes with a preset dose. Wegovy(Semaglutide) marketed by Danish drugmaker Novo Nordisk comes in five strengths 0.25 mg, 0.5 mg, 1 mg, 1.7 mg and 2.4 mg, followed in the same order for prescription from 1 to 5 months. While, its rival Tirzepatide marketed by US-giant Eli Lilly under the brand name Mounjaro is available under two dosage strengths 2.5 mg and 5 mg. Novo Nordisk blockbuster therapy is set to lose its exclusivity in Canada and India by early 2026, potentially triggering a wave of generic competition involving Indian drugmakers. According to PharmaTrac data as of July this year, Semaglutide has a market size of Rs 421 crore and its injectable brand Wegovy reported total sale of Rs 10 crore since its launch in June. MedTech foray outlook From a India perspective we have become an important device player, following the acquisition of a majority stake ( 85.6 per cent stakes for €256.8 million) in France-based Amplitude Surgicals, an implant and robotic technology maker, said Dr Patel. We expect the company's robotic-arms business to improve our revenue in Europe and will launch the products in some other markets including India as well, he outlined. Tariffs tension Over the looming uncertainty of tariffs from the US administration, Dr Patel said, “While US is an important market for the US, there is no clarity, as currently expected for the industry and once they come into play we will analyse the impact and work accordingly to achieve the best after that.” “Generics play a crucial role in the US healthcare system and account for nearly 90 per cent of the total drugs volume that ensures savings, affordability and we are committed to ensure this access in the US," he added. Q1 FY26 results For the April-June quarter the drugmaker reported a revenue of Rs 6,573 crore, up by 5.9 per cent on year-on-year (YoY) basis. However the company’s net profit remained muted with a marginal increase of 1.1 per cent YoY to Rs 1,466 crore. The quarter’s Earnings Before Interest, Taxes, Depreciation, and Amortisation (EBITDA) stood at ₹2,088 crore at a margin of 31.8 per cent, down by the previous fiscal same quarter margin of 33.6 per cent. Non-US international sales reported the highest segmental YoY growth of 36.8 per cent with a revenue of Rs 726.5 crore while the US business remained muted with a marginal increase of 2.9 per cent to Rs 3,181 crore. “For the full fiscal in the US, despite the pricing pressure in Revlimid—a cancer drug—we maintain our existing guidance,” said Dr Patel. In India the company's formulations sales generated Rs 1,519 crore while its consumer wellness segment reported a revenue of Rs 854.9 crore. By Abhijeet Singh ,