Last updated: October 1, 2026
Cosentyx, Novartis’s secukinumab biologic, generated approximately $6.1 billion in 2024 sales, making it one of the company’s largest growth products. Revenue has expanded from roughly $4.8 billion in 2022 to $6.1 billion in 2024 as Novartis broadened use across psoriasis, psoriatic arthritis, axial spondyloarthritis, and hidradenitis suppurativa. The principal commercial risks are biosimilar competition after the U.S. biologic exclusivity period, formulary pressure from IL-17 and IL-23 competitors, and mature-market price erosion.
U.S. FDA approval occurred on January 21, 2015. The statutory 12-year reference-product exclusivity period therefore runs to January 21, 2027, subject to pediatric-exclusivity adjustments and the separate effect of patents. Cosentyx is not an ordinary small-molecule Orange Book product. It is a biologic tracked through the FDA Purple Book, and generic substitution does not apply in the same manner as for conventional tablets.
What is COSENTYX and how does secukinumab work?
Cosentyx is a fully human IgG1/κ monoclonal antibody that selectively binds interleukin-17A, or IL-17A. By blocking IL-17A signaling, secukinumab suppresses inflammatory pathways involved in psoriasis and several immune-mediated rheumatic diseases.
The principal approved U.S. indications include:
| Indication |
FDA status |
Principal commercial relevance |
| Moderate-to-severe plaque psoriasis |
Approved |
Original and largest historical indication |
| Psoriatic arthritis |
Approved |
Expands use beyond dermatology |
| Ankylosing spondylitis |
Approved |
Supports rheumatology demand |
| Non-radiographic axial spondyloarthritis |
Approved |
Earlier-stage axial disease opportunity |
| Pediatric plaque psoriasis |
Approved |
Extends duration of patient use |
| Hidradenitis suppurativa |
Approved in 2023 |
Adds a high-unmet-need inflammatory market |
Cosentyx is administered through subcutaneous injection, with intravenous administration also approved for certain adult patients with psoriatic arthritis, ankylosing spondylitis, or plaque psoriasis. The intravenous formulation gives Novartis an institutional and infusion-center option that most competing self-injectable products do not match directly. [1]
How has COSENTYX revenue changed over time?
Cosentyx has maintained double-digit growth through most of its commercial life. Novartis reported the following net sales:
| Fiscal year |
Cosentyx sales |
Year-over-year change |
| 2021 |
Approximately $4.7 billion |
Low-single-digit growth |
| 2022 |
Approximately $4.8 billion |
Approximately 1% |
| 2023 |
Approximately $5.6 billion |
Approximately 17% reported |
| 2024 |
Approximately $6.1 billion |
Approximately 10% reported |
Sources: Novartis annual reports and fourth-quarter earnings disclosures. [2-5]
The 2023 acceleration reflected broader demand, increased use in rheumatology, and the contribution from hidradenitis suppurativa. Growth in 2024 remained strong despite the product’s maturity and heightened competition from IL-17A, IL-17F, and IL-23 therapies.
Cosentyx represented approximately 12% of Novartis’s 2024 sales of about $50 billion. That creates material revenue exposure to both competitive pricing and future biosimilar entry. The product is less concentrated than a single-indication dermatology drug because its revenue base spans dermatology, rheumatology, and immunology.
What drove the COSENTYX sales trajectory?
The main growth drivers have been:
- Expansion from psoriasis into psoriatic arthritis and axial spondyloarthritis.
- Increasing physician familiarity with IL-17A inhibition.
- Continued uptake in patients who have failed tumor necrosis factor inhibitors or other biologics.
- The addition of hidradenitis suppurativa.
- Expanded dosing and delivery options, including intravenous administration.
- International penetration in markets where biologic access has expanded.
The commercial profile is stronger than it would be for a single-indication product, but the same mechanism also exposes Cosentyx to direct therapeutic substitution. Dermatologists and rheumatologists can move patients among IL-17 and IL-23 inhibitors based on efficacy, dosing interval, safety, payer status, and treatment history.
When does COSENTYX lose U.S. exclusivity?
The FDA approved Cosentyx on January 21, 2015. Under the Biologics Price Competition and Innovation Act, a reference biologic generally receives 12 years of reference-product exclusivity. The baseline U.S. exclusivity date is therefore January 21, 2027. [6]
That date does not guarantee immediate biosimilar launch. A biosimilar applicant must complete FDA approval, satisfy patent-dispute requirements, and address any enforceable patents that remain in force.
| Exclusivity or protection |
Relevant date or period |
Business effect |
| FDA approval |
January 21, 2015 |
Starts the U.S. reference-product timeline |
| Baseline biologic exclusivity |
January 21, 2027 |
Earliest statutory reference-product loss date |
| Pediatric exclusivity |
Product-specific |
Could extend applicable exclusivity if granted |
| Patent protection |
Patent-specific |
May delay biosimilar launch beyond 2027 |
| European regulatory protection |
Country- and product-specific |
Varies by jurisdiction |
The practical launch date depends on the full U.S. patent estate, settlement outcomes, and whether a biosimilar sponsor pursues an at-risk launch. A 2027 loss of regulatory exclusivity is therefore a legal opening, not necessarily the first day of commercial competition.
What patents protect COSENTYX?
Cosentyx’s patent estate is distributed across several categories rather than a single patent:
- Antibodies that bind IL-17A.
- Antibody sequences and variants.
- Pharmaceutical compositions containing secukinumab.
- Subcutaneous and intravenous formulations.
- Dosing regimens for psoriasis and inflammatory arthritis.
- Methods of treating specific patient populations.
- Manufacturing and cell-culture processes.
- Device and delivery-system claims.
The core composition-of-matter and antibody patents were filed years before the 2015 approval and generally have expiration dates in the late 2020s or early 2030s, depending on the patent, patent-term adjustment, supplementary protection certificate, and jurisdiction. Later method-of-use, formulation, dosing, and manufacturing patents may extend the litigation field even when they do not create the same protection as a valid composition patent.
What is the Orange Book status of COSENTYX?
Cosentyx is not listed in the FDA Orange Book as a conventional small-molecule drug. The relevant reference-product and biosimilar records are maintained through the FDA Purple Book. A biosimilar applicant therefore does not file an abbreviated new drug application with a conventional Paragraph IV certification against Orange Book-listed patents.
The biosimilar pathway is a biologics license application under section 351(k) of the Public Health Service Act. Patent disputes proceed under the BPCIA patent-exchange process, commonly called the “patent dance,” followed by litigation under applicable federal patent law. [6-7]
Which companies are challenging COSENTYX?
No Cosentyx biosimilar had received FDA approval as of the latest public regulatory and company disclosures through early 2025. The competitive pressure has instead come from branded products.
| Competitor |
Active mechanism |
Company |
Primary competitive overlap |
| Taltz |
IL-17A antibody |
Eli Lilly |
Psoriasis, psoriatic arthritis, axial spondyloarthritis |
| Bimzelx |
IL-17A and IL-17F inhibitor |
UCB |
Plaque psoriasis and psoriatic arthritis |
| Tremfya |
IL-23 antibody |
Johnson & Johnson |
Psoriasis and psoriatic arthritis |
| Skyrizi |
IL-23 antibody |
AbbVie |
Psoriasis, psoriatic arthritis, inflammatory bowel disease |
| Stelara |
IL-12/23 antibody |
Johnson & Johnson |
Psoriasis and psoriatic arthritis |
| Humira biosimilars |
TNF inhibitor |
Multiple companies |
Earlier-line and payer-driven substitution |
| Remicade biosimilars |
TNF inhibitor |
Multiple companies |
Rheumatology and hospital channels |
Taltz is the closest branded mechanism competitor because it also selectively inhibits IL-17A. Bimzelx creates a newer mechanistic challenge by targeting both IL-17A and IL-17F. IL-23 inhibitors compete through longer dosing intervals and strong psoriasis efficacy, although they do not provide the same indication profile across axial spondyloarthritis.
How does COSENTYX compare with Taltz and IL-23 inhibitors?
Cosentyx has a broad indication base and a mature safety database. Its principal advantage is coverage across dermatology and rheumatology, with an additional hidradenitis suppurativa indication. Taltz has comparable strength in psoriasis and axial disease, while IL-23 inhibitors often compete on dosing convenience and durable skin clearance.
| Factor |
Cosentyx |
Taltz |
IL-23 inhibitors |
| Primary target |
IL-17A |
IL-17A |
IL-23 |
| Dermatology position |
Strong |
Strong |
Very strong |
| Axial disease position |
Strong |
Strong |
More limited |
| Hidradenitis suppurativa |
Approved |
Not broadly equivalent |
Product-specific |
| Dosing convenience |
Moderate |
Moderate |
Often favorable |
| Biosimilar exposure |
Future risk |
Future risk |
Product-specific |
| Commercial maturity |
High |
High |
Mixed, with major growth |
The main strategic tension is between breadth and convenience. Cosentyx has more established cross-specialty use, while certain IL-23 products offer less frequent dosing and strong payer positioning in plaque psoriasis.
What is the FDA regulatory status of COSENTYX?
Cosentyx is a fully approved biologic with multiple supplemental indications. The FDA has accepted the product across several inflammatory conditions, and the 2023 hidradenitis suppurativa approval materially widened its commercial opportunity. [1]
The regulatory profile supports lifecycle management through:
- New indications.
- Pediatric label expansion.
- Intravenous dosing.
- Subcutaneous prefilled syringes and pens.
- Higher-dose regimens where supported by the label.
- Additional evidence in difficult-to-treat or biologic-experienced populations.
Regulatory risk is lower than development-stage risk because the product has an extensive clinical record. The more important regulatory question is whether future trials produce meaningful differentiation rather than merely preserve an existing indication base.
What generic or biosimilar launch risks exist for COSENTYX?
The most likely U.S. erosion pattern is gradual biosimilar adoption rather than immediate generic-style substitution. Several factors support this assessment:
- Interchangeability designations may not be available at initial approval.
- Prescriber familiarity with the originator can delay switching.
- Specialty pharmacies and payer contracts influence product selection.
- Patients may remain on Cosentyx if disease control is stable.
- Novartis can use rebates, contracting, and patient-support programs to defend share.
- Manufacturing complexity raises the cost of biosimilar entry.
The risk increases after payers establish preferred biosimilar products and specialty pharmacies implement automatic or semi-automatic substitution protocols. Dermatology may experience faster switching than rheumatology if payers use preferred-product mandates. Intravenous administration creates a separate channel in which site-of-care economics and buy-and-bill reimbursement can affect adoption.
How strong is the COSENTYX patent estate?
Cosentyx has a commercially meaningful but aging patent estate. Its strongest protection is expected to come from valid composition, formulation, and manufacturing claims. Method-of-use patents can support litigation but are more vulnerable to design-around strategies and physician-prescribing limitations.
Patent-strength assessment
| Patent category |
Relative strength |
Commercial role |
| Antibody composition |
High if valid and enforceable |
Primary barrier to biosimilar launch |
| Formulation |
Moderate to high |
Can block specific presentations |
| Dosing regimen |
Moderate |
Supports labeled-use protection |
| Method of treatment |
Moderate |
Useful against targeted indications |
| Manufacturing process |
Moderate |
Can raise development costs |
| Device and delivery system |
Moderate |
Protects presentation, not necessarily molecule |
The estate’s effective strength depends on claim scope, prosecution history, terminal disclaimers, patent-term adjustments, obviousness challenges, written-description support, and the biosimilar’s proposed manufacturing process. A biosimilar company may avoid certain formulation or process claims while still pursuing approval.
What patent litigation and settlement issues affect COSENTYX?
The most relevant future litigation would involve a biosimilar sponsor challenging antibody, formulation, manufacturing, or dosing patents under the BPCIA framework. Publicly disclosed information through early 2025 did not establish a major, market-shaping Cosentyx biosimilar settlement comparable to the major Humira settlement wave.
A settlement could produce an agreed entry date before the last asserted patent expires. The economic value would depend on:
- The negotiated launch date.
- Whether entry is limited to non-patented indications.
- Royalty obligations.
- Manufacturing restrictions.
- Interchangeability status.
- Whether multiple biosimilar competitors enter simultaneously.
No public settlement should be treated as a confirmed Cosentyx launch date unless Novartis, the biosimilar sponsor, or a court record discloses the terms.
What licensing deals support COSENTYX?
Cosentyx is primarily an internally developed Novartis product rather than an asset known for a major late-stage external licensing transaction. Its commercial value resides within Novartis Pharmaceuticals, and the company has retained global control over development and commercialization.
This structure gives Novartis greater control over pricing, lifecycle management, manufacturing, and indication sequencing. It also means that future value transfer is more likely to arise through manufacturing agreements, regional commercialization arrangements, or biosimilar settlements than through a major originator royalty stream.
What is the geographic coverage and market opportunity?
Cosentyx is marketed across major pharmaceutical markets, including the United States, Europe, Japan, and other regions where biologic access and reimbursement support IL-17 therapies.
The United States remains the largest profit pool because of higher biologic pricing and broad specialty-pharmacy distribution. Europe provides substantial patient volume but lower net pricing. Emerging markets offer volume growth but face tender pricing, reimbursement restrictions, and local manufacturing requirements.
Geographic risks include:
- European biosimilar and biologic price controls.
- National reimbursement decisions.
- Tender-based purchasing.
- Local patent enforcement differences.
- Currency movement.
- Restrictions on biologic switching.
- Variable access to specialty medicines.
What is the outlook for COSENTYX revenue?
Cosentyx should remain a multibillion-dollar product through the second half of the 2020s. Revenue growth is likely to decelerate as the product matures, but the hidradenitis suppurativa launch and continued rheumatology expansion provide offsets.
The main financial scenarios are:
| Scenario |
Commercial outcome |
| Base case |
Continued growth through 2025-2026, followed by slower growth as exclusivity approaches |
| Upside case |
Strong hidradenitis suppurativa uptake, continued share gains, and delayed biosimilar entry |
| Downside case |
IL-23 substitution, aggressive payer discounts, and early biosimilar launch |
| Severe erosion case |
Multiple biosimilars gain preferred status soon after 2027 |
A gradual decline after U.S. biosimilar entry is more probable than an immediate collapse because Cosentyx has multiple indications, established prescriber loyalty, and a broad international business. The largest revenue risk is concentrated in the U.S. market, where payer control and specialty-pharmacy substitution can accelerate erosion.
Key Takeaways
- Cosentyx generated approximately $6.1 billion in 2024 sales.
- Sales increased from approximately $4.8 billion in 2022 to $5.6 billion in 2023 and $6.1 billion in 2024.
- The product represents about 12% of Novartis’s annual revenue.
- U.S. FDA approval occurred on January 21, 2015.
- Baseline U.S. biologic exclusivity runs to January 21, 2027.
- Cosentyx is a Purple Book biologic, not a conventional Orange Book small-molecule product.
- No Cosentyx biosimilar had received FDA approval through early 2025.
- Taltz is the closest IL-17A competitor; Bimzelx and IL-23 inhibitors create broader class pressure.
- Hidradenitis suppurativa and rheumatology remain important growth drivers.
- The patent estate covers antibody composition, formulations, dosing, methods of use, manufacturing, and delivery systems.
- Biosimilar erosion is likely to be gradual but could accelerate through payer-preferred contracting.
- Novartis’s principal defense is indication breadth, established clinical use, lifecycle management, and commercial contracting.
FAQs
Will COSENTYX face biosimilar competition in 2027?
The statutory U.S. reference-product exclusivity period ends in January 2027, but patent disputes, settlement agreements, and FDA approval timing may delay actual commercial entry.
Is COSENTYX an Orange Book drug?
No. Cosentyx is a biologic reference product tracked through the FDA Purple Book. Conventional ANDA Paragraph IV procedures do not apply.
Which drug is the closest competitor to COSENTYX?
Taltz is the closest mechanism competitor because both products selectively inhibit IL-17A. Bimzelx competes within the IL-17 class through dual IL-17A and IL-17F inhibition.
Does COSENTYX have an interchangeable biosimilar?
No interchangeable Cosentyx biosimilar had been approved by the FDA through early 2025.
What is the largest long-term threat to COSENTYX sales?
The largest threat is a combination of IL-23 class substitution before biosimilar entry and payer-driven biosimilar switching after the U.S. exclusivity and patent barriers weaken.
References
- U.S. Food and Drug Administration. (2024). Cosentyx (secukinumab) prescribing information. https://www.accessdata.fda.gov
- Novartis AG. (2022). Annual report 2022. https://www.novartis.com/investors/financial-data/annual-reporting
- Novartis AG. (2023). Annual report 2023. https://www.novartis.com/investors/financial-data/annual-reporting
- Novartis AG. (2024). Annual report 2024. https://www.novartis.com/investors/financial-data/annual-reporting
- Novartis AG. (2025). Fourth-quarter and full-year 2024 results. https://www.novartis.com/news/media-releases
- U.S. Food and Drug Administration. (2023). Biologics price competition and innovation act of 2009. https://www.fda.gov/drugs/therapeutic-biologics-applications-bla
- U.S. Food and Drug Administration. (2024). Purple Book: Database of licensed biological products. https://purplebooksearch.fda.gov
