Last updated: September 7, 2026
Secukinumab, marketed as Cosentyx by Novartis, is one of the largest global IL-17 biologics. Product sales increased from approximately $4.7 billion in 2021 to $6.1 billion in 2024, driven by expanded indications, growth in rheumatology, entry into hidradenitis suppurativa, and continued use in plaque psoriasis. The principal commercial risks are competition from IL-23 inhibitors, IL-17 competitors, biosimilar entry after U.S. biologic exclusivity, and pricing pressure in Europe and other tender-driven markets.
How much revenue does Cosentyx generate?
Cosentyx generated approximately $6.1 billion in 2024 sales, representing about 12% of Novartis' total company revenue. Growth has slowed from the high-growth phase following the product's launch, but the franchise remains one of Novartis' core revenue assets.
| Fiscal year |
Cosentyx sales |
Approximate year-over-year change |
| 2021 |
$4.7 billion |
10% |
| 2022 |
$5.0 billion |
6% |
| 2023 |
$6.0 billion |
20% |
| 2024 |
$6.1 billion |
2% |
Source: Novartis annual reports and results releases.[1-4]
The 2023 increase reflected volume growth and broader use across dermatology and rheumatology. The 2024 trajectory was more mature. Novartis reported continued volume expansion, but the product faced a more competitive immunology market and unfavorable effects from pricing, foreign exchange, and loss of exclusivity concerns in certain markets.
What explains the financial trajectory?
Cosentyx has benefited from five commercial factors:
- A broad label covering plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, and hidradenitis suppurativa.
- Durable positioning as an established IL-17 inhibitor with extensive clinical experience.
- Strong dermatology adoption, particularly in moderate-to-severe plaque psoriasis.
- Expansion into intravenous administration for selected adult indications.
- Continued geographic penetration in emerging markets and markets where IL-17 therapy is preferred.
The principal constraint is that Cosentyx is no longer competing mainly against older TNF inhibitors. Newer IL-23 products, including risankizumab and guselkumab, have taken share in psoriasis because of convenient dosing and strong skin-clearance outcomes. Bimekizumab also competes directly in the IL-17 class with dual IL-17A and IL-17F inhibition.
What indications and formulations are protected by secukinumab?
Cosentyx is a recombinant human monoclonal antibody that selectively binds interleukin-17A. The FDA approved the product in 2015 for moderate-to-severe plaque psoriasis in adults. Subsequent U.S. approvals expanded the label into psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, pediatric plaque psoriasis, and hidradenitis suppurativa.[5]
| Indication |
Commercial relevance |
Principal competitive set |
| Plaque psoriasis |
Original and largest dermatology market |
Skyrizi, Tremfya, Taltz, Bimzelx, Stelara, TNF inhibitors |
| Psoriatic arthritis |
Large rheumatology indication |
IL-23 drugs, TNF inhibitors, JAK inhibitors, Taltz |
| Ankylosing spondylitis |
Established IL-17 use |
TNF inhibitors, Taltz, JAK inhibitors |
| Non-radiographic axial spondyloarthritis |
Expands earlier-line axial disease use |
TNF inhibitors, Taltz, JAK inhibitors |
| Hidradenitis suppurativa |
Newer growth opportunity |
Humira, Bimzelx, other pipeline biologics |
| Pediatric plaque psoriasis |
Extends lifecycle and prescriber base |
Stelara, Taltz, Tremfya and other pediatric biologics |
The subcutaneous formulation is the core commercial product. Novartis also obtained FDA approval for an intravenous formulation for certain adult patients with plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis.[6] The IV product can support hospital and infusion-center use, but it also creates additional manufacturing, reimbursement, and administration complexity.
What formulations are protected by Cosentyx patents?
The patent estate includes claims directed to the anti-IL-17A antibody, antibody sequences, therapeutic use, formulations, dosing regimens, and manufacturing-related subject matter. The commercial risk is therefore not limited to the expiration of a single composition patent.
Representative U.S. patent families publicly associated with secukinumab include:
| Patent |
General subject matter |
Reported U.S. term profile |
| U.S. Patent No. 8,110,197 |
Anti-IL-17A antibodies and related biological activity |
Mid-2020s, subject to term adjustments and applicable extensions |
| U.S. Patent No. 8,623,361 |
Anti-IL-17A antibody claims and related embodiments |
Late 2020s, subject to continuation and term analysis |
| Later continuation and formulation families |
Dosing, pharmaceutical compositions, administration, and manufacturing |
Expiration dates vary by family and patent-term adjustment |
Patent scope depends on the claims that remain in force, terminal disclaimers, patent-term adjustment, patent-term extension, and the specific biosimilar's manufacturing process. A composition patent expiry does not automatically establish an unrestricted launch date.
When does secukinumab lose exclusivity in the United States?
U.S. biologic exclusivity and patent protection are separate.
Cosentyx received its first U.S. licensure in 2015. Under the Biologics Price Competition and Innovation Act, the reference product receives 12 years of FDA reference-product exclusivity. The core statutory period therefore reaches its 2027 timeframe, subject to pediatric exclusivity and the exact reference-product date recognized by FDA.[7]
| Protection category |
Estimated relevance to Cosentyx |
| FDA biologic reference-product exclusivity |
Reaches the 2027 timeframe |
| Core composition and antibody patents |
Some publicly reported families expire before or around the late 2020s |
| Continuation, formulation, dosing, and manufacturing patents |
May extend protection beyond core composition terms |
| Regulatory exclusivity in Europe |
Earlier protection periods may have expired or be approaching expiry, depending on product and indication |
| Market exclusivity after biosimilar approval |
Depends on patent settlements, injunctions, and biosimilar launch terms |
The practical U.S. launch date for a biosimilar is likely to depend on negotiated settlements and the surviving patent portfolio rather than on FDA exclusivity alone. Biosimilar applicants can pursue FDA approval before commercial launch if patent litigation or settlement terms delay market entry.
What is the Orange Book status of Cosentyx?
Cosentyx is not listed in the FDA Orange Book as a conventional small-molecule drug. It is licensed as a biologic under a biologics license application. Patent and exclusivity analysis is therefore conducted through the FDA Purple Book, FDA biologics records, patent databases, and the BPCIA patent-exchange and litigation framework.[7-8]
The Orange Book does not provide the same patent-listing function for Cosentyx that it provides for a tablet or small-molecule injectable. A generic drug application is not the normal pathway for a competitor to copy secukinumab. The relevant pathway is a 351(k) biosimilar application.
Which companies are challenging secukinumab exclusivity?
As of the latest publicly available information through 2024, no FDA-approved secukinumab biosimilar had reached the U.S. market. The public competitive threat is therefore more immediate from branded immunology products than from marketed biosimilars.
Potential competitors fall into four groups:
- Large biologics companies developing IL-17 or IL-23 products.
- Biosimilar developers assessing 351(k) entry.
- Manufacturers seeking regional approvals outside the United States.
- Companies competing through oral JAK inhibitors and other non-biologic immunomodulators.
A biosimilar challenge would require analytical similarity, clinical and pharmacokinetic evidence, manufacturing comparability, and resolution of patent issues. The manufacturing barrier is material because secukinumab is a complex monoclonal antibody produced through a controlled cell-culture and purification process.
How strong is the secukinumab patent estate?
The estate is commercially strong but not immune to erosion.
Strengths
- Early composition and antibody patents provide a foundation for the franchise.
- Continuation filings can preserve claim coverage across antibody variants, uses, dosing, and formulations.
- Broad labeling creates multiple potential method-of-use positions.
- Manufacturing and formulation patents can complicate biosimilar development even after core composition claims expire.
- The product has substantial sales, making patent litigation economically attractive for both the innovator and challengers.
Weaknesses
- The first U.S. approval occurred in 2015, so the product is approaching the end of its initial exclusivity cycle.
- A biosimilar can potentially enter with a manufacturing process that avoids selected process claims.
- Method-of-use patents can be narrower and more vulnerable to non-infringement or invalidity arguments.
- Treatment of multiple indications may make some claims difficult to enforce against a product sold with a narrower label.
- Patent expiry dates vary across jurisdictions and claim categories.
The estate is best viewed as a layered protection structure rather than as a single blocking patent. The highest-value litigation issues are likely to involve antibody composition, formulation, dosing, and manufacturing claims.
What patent litigation and settlement risks affect Cosentyx?
The commercial risk from biosimilar litigation is likely to increase as the 2027 U.S. exclusivity milestone approaches. A challenger may file a 351(k) application and initiate the BPCIA patent-exchange process. Novartis could then assert selected patents in federal court, seek a negotiated launch date, or accept an at-risk launch subject to litigation.
Possible launch outcomes include:
| Scenario |
Likely commercial effect |
| No biosimilar settlement before approval |
Litigation-driven uncertainty and possible at-risk entry |
| Settlement with launch near core patent expiry |
Moderate erosion, often beginning with a limited number of competitors |
| Multiple biosimilar approvals and no meaningful blocking patent |
Rapid price and volume pressure |
| Settlement with delayed entry |
Preserves revenue through the agreed launch date |
| Narrow-label biosimilar launch |
Slower erosion in protected indications, but substitution pressure remains |
The absence of a marketed U.S. biosimilar through 2024 does not eliminate future entry risk. It indicates that the market had not yet reached the point at which a competitor had both regulatory readiness and a commercially acceptable patent strategy.
How does Cosentyx compare with competing biologics?
Cosentyx remains differentiated by its breadth across dermatology and axial spondyloarthritis. Its weaknesses are dosing frequency in some regimens and increasing competition from drugs with longer maintenance intervals.
| Product |
Company |
Class |
Main competitive advantage |
| Cosentyx |
Novartis |
IL-17A inhibitor |
Broad label and established IL-17 experience |
| Taltz |
Eli Lilly |
IL-17A inhibitor |
Direct class competitor with strong psoriasis and axial disease positioning |
| Bimzelx |
UCB |
IL-17A/IL-17F inhibitor |
Dual cytokine inhibition and strong psoriasis efficacy |
| Skyrizi |
AbbVie |
IL-23 inhibitor |
Convenient dosing and strong psoriasis growth |
| Tremfya |
Johnson & Johnson |
IL-23 inhibitor |
Dermatology and rheumatology expansion |
| Stelara |
Johnson & Johnson |
IL-12/23 inhibitor |
Large installed base and broad historical use |
| Humira |
AbbVie and biosimilar manufacturers |
TNF inhibitor |
Extensive physician familiarity and lower-cost alternatives |
IL-23 inhibitors are the most important branded threat in plaque psoriasis. IL-17 agents remain more competitive in axial spondyloarthritis, where rapid symptom improvement and spinal disease efficacy are important treatment considerations. Hidradenitis suppurativa gives Cosentyx a newer growth avenue, but the market is becoming more crowded and treatment selection depends on disease severity, prior biologic exposure, and payer policy.
What is the FDA regulatory status of secukinumab?
Cosentyx is FDA-approved in multiple adult and pediatric immune-mediated diseases. The product has an established biologics license and a mature safety database. The FDA label includes warnings and precautions relevant to infections, inflammatory bowel disease, hypersensitivity, and immunization considerations.[5]
The regulatory strategy has shifted from initial product validation to lifecycle expansion. The principal regulatory value now comes from:
- New indications such as hidradenitis suppurativa.
- Pediatric label expansion.
- Intravenous administration.
- New dosing regimens and patient subgroups.
- Geographic approvals and reimbursement expansion.
Regulatory expansion can delay revenue decline by increasing treated-patient volume, even when the product's original psoriasis market is mature.
What generic entry risks exist for secukinumab?
Traditional generic entry risk is low because secukinumab is a biologic. Biosimilar entry risk is material.
The first erosion phase is likely to be slower than for a conventional small molecule because:
- Biosimilar development costs are high.
- Interchangeability is not automatic in every market.
- Physicians may remain loyal to the reference product.
- Payers may use formulary controls rather than automatic substitution.
- Manufacturing and supply reliability matter for a complex antibody.
- Novartis may defend share through contracting, rebates, and patient-support programs.
Once several biosimilars are available, price competition can accelerate. European markets generally experience earlier and more aggressive biologic price erosion than the United States because tender systems and centralized purchasing exert greater pressure.
How exposed is Novartis to Cosentyx revenue loss?
Cosentyx is a major product but not Novartis' only large growth asset. Its approximately $6.1 billion in 2024 sales represent roughly one-eighth of Novartis' total revenue. A 10% decline would reduce annual sales by approximately $600 million before offsetting effects. A 30% decline would imply approximately $1.8 billion in annual revenue exposure.
| Revenue erosion case |
Approximate annual sales impact |
| 10% decline |
$0.6 billion |
| 20% decline |
$1.2 billion |
| 30% decline |
$1.8 billion |
| 50% decline |
$3.1 billion |
The risk is manageable at the group level because Novartis has other large products, including Entresto, Kesimpta, Kisqali, Leqvio, and Pluvicto. It remains significant for the immunology portfolio, where Cosentyx is a principal revenue contributor.
What is the outlook for Cosentyx after 2025?
The base case is continued growth or stability through lifecycle expansion, followed by gradual pressure as biologic exclusivity and patent barriers weaken. Hidradenitis suppurativa and IV administration can extend the product's commercial life, but they are unlikely to eliminate the eventual impact of biosimilar competition.
The most likely trajectory is:
- Continued low- to mid-single-digit growth from new indications and international markets.
- Increasing share pressure from IL-23 products in plaque psoriasis.
- Greater importance of contracting and payer access.
- Biosimilar preparation before or around the 2027 U.S. exclusivity milestone.
- A gradual erosion phase rather than an immediate generic-style collapse.
- Faster price pressure in Europe than in the United States.
Key Takeaways
- Cosentyx sales reached approximately $6.1 billion in 2024, making it one of Novartis' largest products.
- The franchise has moved from rapid expansion to mature-growth management.
- Hidradenitis suppurativa, pediatric use, and IV administration are the main lifecycle extensions.
- IL-23 products are the strongest branded competitive threat in plaque psoriasis.
- U.S. biologic exclusivity reaches the 2027 timeframe, but patent settlements may determine the practical biosimilar launch date.
- Cosentyx is not an Orange Book small molecule; biosimilar risk is governed by the Purple Book and BPCIA framework.
- Revenue erosion is likely to be gradual at first, then accelerate if multiple biosimilars enter simultaneously.
- A 30% decline would represent approximately $1.8 billion in annual sales exposure for Novartis.
FAQs
Can a generic drug replace Cosentyx?
No. A conventional generic cannot substitute for Cosentyx. Competitors must generally use the FDA 351(k) biosimilar pathway or the applicable regulatory pathway outside the United States.
Is Cosentyx interchangeable with a biosimilar?
Interchangeability depends on FDA designation and state substitution rules. Biosimilarity alone does not automatically create pharmacy-level substitution in the United States.
Does Cosentyx have patent protection beyond 2030?
Some continuation, formulation, dosing, or manufacturing patents may extend into or beyond the 2030s, but protection must be assessed patent by patent. Core composition and regulatory exclusivity expire earlier.
Which Cosentyx indication has the greatest long-term commercial value?
Plaque psoriasis remains the largest commercial base, while psoriatic arthritis and axial spondyloarthritis support durability. Hidradenitis suppurativa provides the most important newer growth opportunity.
Will IL-23 inhibitors replace Cosentyx?
They are likely to take share in plaque psoriasis, but complete replacement is unlikely. Cosentyx retains value in axial spondyloarthritis, psoriatic arthritis, established patients, and markets where IL-17 therapy has strong physician adoption.
References
- Novartis AG. (2022). Annual report 2021.
- Novartis AG. (2023). Annual report 2022.
- Novartis AG. (2024). Annual report 2023.
- Novartis AG. (2025). Annual report 2024.
- U.S. Food and Drug Administration. (2024). Cosentyx prescribing information.
- U.S. Food and Drug Administration. (2023). FDA approves intravenous formulation of Cosentyx for selected adult inflammatory diseases.
- U.S. Food and Drug Administration. (2024). Purple Book: Database of licensed biological products.
- U.S. Patent and Trademark Office. (2024). Patent Center and patent term information for U.S. patents associated with anti-IL-17A antibody products.
