10 Drugs Losing Exclusivity This Year

A wave of high-profile drugs is set to lose patent protection in 2026.

NEW BRUNSWICK, N.J. — For years, Johnson & Johnson's "Stelara Cliff" had loomed on the horizon like a terminal diagnosis for the firm’s immunology revenue. Stelara, the blockbuster psoriasis and Crohn’s treatment that once accounted for 20% of the company’s innovative medicine sales, officially saw its U.S. exclusivity dissolve on January 1, 2025. Yet, as the company reported its first-year results in the post-exclusivity era, CEO Joaquin Duato declared the cliff "in the rearview mirror."

J&J’s navigation of this transition — successfully pivoting to oncology and robotic surgery even as biosimilar competitors like Amgen’s Wezlana began their erosion — serves as the definitive case study for 2026. It proves that for the modern pharmaceutical giant, the patent cliff is no longer a drop-off, but a bridge to the next era of precision medicine.

Meanwhile, Merck’s leadership is no longer fighting to hold the line on Januvia, a cornerstone of the firm’s diabetes franchise. Instead, they have leaned into the "Grand Bargain" of the current administration, securing tariff exemptions and favorable positioning for their next-generation pipeline in exchange for a graceful, domestic-first transition to generic sitagliptin. This narrative, making way for a more agile, interventionist architecture, is playing out across the sector.

2026's Notable Patent Cliffs

As we move into 2026, ten more key medicines are set to follow Stelara into the generic frontier, bringing expanded access to millions while forcing the industry’s most interventionist leaders to once again master the art of the strategic pivot.

1. Eliquis (apixaban)

Perhaps the most high-stakes drama in the 2026 cycle involves the world’s leading anticoagulant (blood thinner). Generating over $12 billion annually, Eliquis has been a cornerstone of the BMS-Pfizer alliance (NYSE: BMY, PFE). While primary composition patents theoretically hold, key U.S. formulations face a critical "regulatory opening" in late 2026.

In a move that stunned the markets in December 2025, BMS CEO Chris Boerner entered into a direct-to-government agreement to provide Eliquis at a fixed price in exchange for three years of tariff relief, a masterclass in "Sovereign Realism" that bridges the gap until the full generic erosion of 2028.

2. Januvia & Janumet (sitagliptin)

Merck & Co.'s (NYSE: MRK) diabetes powerhouse, generating a combined $3.7 billion in 2024, has reached the end of its storied monopoly. While the core compound patent expired in 2023, a strategic "salt and polymorph" thicket extended its life until May 2026. Under a long-standing Paragraph IV settlement, generic giants like Teva and Viatris are now clearing the final hurdles to launch.

For Merck, the 2026 cliff is a $2.5 billion revenue headwind that the company is offsetting with a heavy pivot into cardiovascular "Sputnik" projects and a $9 billion acquisition streak.

3. Ozempic (semaglutide)

Novo Nordisk (NYSE: NVO): The cultural and commercial phenomenon of the decade faces its first structural breach. While Novo Nordisk has built a formidable patent fortress in the U.S. extending to 2031, its core patents in China expire in 2026. This has triggered a massive capital flow into "East-West" generic strategies.

In the U.S., a series of confidential settlements reached in late 2025 has opened the door for "authorized generics" to handle the demand that Novo’s own supply chain has struggled to meet, effectively turning a patent cliff into a managed supply solution.

4. Bridion (sugammadex)

A staple in hospital surgical suites, Bridion’s unique ability to reverse neuromuscular blockade made it a high-margin essential. Following a 2025 Federal Circuit ruling that upheld Merck’s five-year patent term extension (PTE), the medicine’s exclusivity finally dissolves in January 2026. The arrival of generic sugammadex is expected to collapse anesthesia costs for health systems by up to 80% within the first six months, testing Merck’s ability to defend its hospital-channel relationships.

5. Victoza (liraglutide)

Novo Nordisk (NYSE: NVO): Before there was Ozempic, there was Victoza. As the precursor to the modern GLP-1 craze, Victoza’s primary U.S. patents have reached their terminal date in 2026. This marks the first major entry of biosimilar GLP-1s into the American market.

For Novo Nordisk, this is a calculated exit; the firm is actively migrating its entire patient base to the superior semaglutide platform, leaving the "liraglutide legacy" to become the high-volume, low-cost backbone of the TrumpRx diabetes portal.

6. Rexulti (brexpiprazole)

Otsuka / Lundbeck (OTC: OTKPY): The mental health sector faces a significant shift as Rexulti, indicated for schizophrenia and Alzheimer’s-related agitation, reaches its primary patent expiration in April 2026. Generating over $1.5 billion in annual sales, its transition to generic availability is a pivotal moment for public health access. Generic manufacturers are already positioning "180-day exclusivity" claims, promising a rapid price erosion that will challenge Otsuka’s ability to sustain its CNS (Central Nervous System) franchise.

7. Briviact (brivaracetam)

UCB (OTC: UCBJF): The epilepsy market prepares for the entry of generic brivaracetam in February 2026. As UCB’s second-generation anti-epileptic, Briviact has been a high-growth asset. With its core patents expiring, the company is shifting its focus to its rare disease immunology pipeline. For neurologists and patients, the 2026 cliff represents a major win for affordability in chronic seizure management.

8. Entresto (sacubitril/valsartán)

The heart failure blockbuster has been the subject of a multi-year legal siege. Despite Novartis’s (NYSE: NVS) valiant defense of its combination patents, the core U.S. protections reach a critical sunset in 2026. Having already faced "at-risk" generic launches in some jurisdictions, Novartis is now utilizing a "Sovereign AI" strategy to optimize its remaining manufacturing processes, attempting to maintain a margin advantage even as Novadoz and other generics enter the fray.

9. Xeljanz (tofacitinib)

Pfizer's (NYSE: PFE) foundational JAK inhibitor for rheumatoid arthritis and ulcerative colitis faces a definitive patent cliff in 2026. With global sales having already been tempered by safety labeling changes, the arrival of generics marks the end of an era for Xeljanz. Pfizer is responding by aggressively accelerating its next-generation immunology assets, trading the Xeljanz cash flow for "National Priority Vouchers" on its newer, domestically made biologics.

10. Voltaren Gel (diclofenac)

A household name in pain management, Voltaren’s prescription-strength exclusivity for its topical formulation ends in June 2026. While the OTC version remains a consumer staple, the patent expiration resets the pricing floor for the heavy-duty clinical formulations. For GSK (NYSE: GSK), this is the final chapter of a legacy brand, allowing the firm to fully reallocate capital toward its "Fortress America" respiratory and vaccine hubs.

The New Alpha of Resilience

As the sun sets on the era of the "uncontested blockbuster," the 2026 patent cliff serves as more than just a fiscal hurdle; it is a catalyst for a fundamental re-engineering of the biopharmaceutical firm.

Success in this new landscape is being defined by three distinct strategic shifts:

1. The Capital Rotation Toward "Clean" Assets: Investors have moved decisively away from speculative, early-stage platforms toward de-risked, late-stage assets with U.S.-centric manufacturing. In 2026, a company’s valuation is increasingly a reflection of its political resilience and its ability to participate in the "Grand Bargain" of domestic re-shoring.

2. The Convergence of AI and Industrialization: We have moved beyond the "AI for discovery" hype. The winners of 2026 are using AI to automate the clinical review process and optimize manufacturing throughput, effectively trading the purity of the old scientific method for the raw speed required to secure National Priority Vouchers.

3. Transactional Governance as a Core Competency: The boardroom has become a satellite of the Situation Room. The most successful executives are those who treat the administration as a lead investor, offering domestic investment and pricing transparency in exchange for the regulatory "fast lanes" that allow them to leapfrog the competition.

The stunning rebound of Wall Street’s biotech indices this February is not a signal that the storm has passed, but a vote of confidence in those who have learned to sail in it. The 2026 patent cliff did not break the industry; it broke the industry's reliance on the past.

As we move forward, the "alpha" will belong to the operators who view every cliff not as a drop-off, but as the necessary demolition required to build something more enduring.

The data for this article has been obtained from the FDA’s publication regarding Approved Drug Products with Therapeutic Equivalence Evaluations, evaluating patent and exclusivity information.

Read more about the impact of federal research funding cuts on the future of medicine and learn about the most anticipated drug launches of 2025.

Further Reading:

• Innovation Under Siege: NIH to Cut Billions in Research Funding

• Three Months In: Biopharma & Regulation in 2025

• Unravelling the Consequences: NIH Budget Cuts Are Affecting Research

• 2025's Most Anticipated Drug Launches

• Why Drug Repurposing Can Unlock the Untapped Potential of Existing Medicines

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