Brodalumab - Biologic Drug Details

Summary for brodalumab

Tradenames:	1
High Confidence Patents:	9
Applicants:	1
BLAs:	1
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for brodalumab

Recent Clinical Trials for brodalumab

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Bausch Health	PHASE1
Brian Henick, MD	PHASE1
South Valley University	NA

See all brodalumab clinical trials

Pharmacology for brodalumab

Mechanism of Action	Interleukin 17 Receptor A Antagonists
Established Pharmacologic Class	Interleukin-17 Receptor A Antagonist
Chemical Structure	Antibodies, Monoclonal

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. DrugPatentWatch analysis and brand-side disclosures

These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for brodalumab Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for brodalumab Derived from DrugPatentWatch Analysis and Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Valeant Pharmaceuticals Luxembourg S.à.r.l.	SILIQ	brodalumab	Injection	761032	10,022,437	2035-08-28	DrugPatentWatch analysis and company disclosures
Valeant Pharmaceuticals Luxembourg S.à.r.l.	SILIQ	brodalumab	Injection	761032	10,400,007	2034-04-15	DrugPatentWatch analysis and company disclosures
Valeant Pharmaceuticals Luxembourg S.à.r.l.	SILIQ	brodalumab	Injection	761032	10,513,546	2034-12-18	DrugPatentWatch analysis and company disclosures
Valeant Pharmaceuticals Luxembourg S.à.r.l.	SILIQ	brodalumab	Injection	761032	10,696,750	2039-01-31	DrugPatentWatch analysis and company disclosures
Valeant Pharmaceuticals Luxembourg S.à.r.l.	SILIQ	brodalumab	Injection	761032	11,046,750	2040-05-14	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for brodalumab Derived from Patent Text Search

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Valeant Pharmaceuticals Luxembourg S.à.r.l.	SILIQ	brodalumab	Injection	761032	10,039,810	2035-05-15	Patent claims search
Valeant Pharmaceuticals Luxembourg S.à.r.l.	SILIQ	brodalumab	Injection	761032	10,111,968	2036-08-10	Patent claims search
Valeant Pharmaceuticals Luxembourg S.à.r.l.	SILIQ	brodalumab	Injection	761032	10,369,114	2037-05-24	Patent claims search
Valeant Pharmaceuticals Luxembourg S.à.r.l.	SILIQ	brodalumab	Injection	761032	10,590,182	2036-02-23	Patent claims search
Valeant Pharmaceuticals Luxembourg S.à.r.l.	SILIQ	brodalumab	Injection	761032	10,907,186	2040-05-15	Patent claims search

International Patents for brodalumab

Country	Patent Number	Estimated Expiration
Australia	2020214812
Poland	2370099
South Korea	20160148720
San Marino	T202000411
Norway	344867

Supplementary Protection Certificates for brodalumab

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
CA 2017 00063	Denmark		PRODUCT NAME: ISOLERET ANTISTOF ELLER FRAGMENT DERAF OMFATTENDE LET KAEDE OG TUNG KAEDE CDR-SEKVENSER IFOELGE EP-B1-2076541 KRAV 1 (SEQ ID NO: 224, 225, 226 OG 146, 147, 148).....; REG. NO/DATE: EU/1/16/1155/001-002 20170719
132018000000041	Italy		PRODUCT NAME: BRODALUMAB(KYNTHEUM); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1155/001-002, 20170719
2018C/005	Belgium		PRODUCT NAME: KYNTHEUM; AUTHORISATION NUMBER AND DATE: EU/1/16/1155/001-002 20170717
2018/003	Ireland		PRODUCT NAME: BRODALUMAB; REGISTRATION NO/DATE: EU/1/16/1155/001-002 20170717
122017000126	Germany		PRODUCT NAME: EIN ISOLIERTER ANTIKOERPER ODER EIN FRAGMENT DAVON, UMFASSEND CDR-SEQUENZEN DER LEICHTEN KETTE UND DER SCHWEREN KETTE NACH EP-B1-2076541 ANSPRUCH 1 (SEQ ID NOS: 224, 225, 226 UND 146, 147, 148), WOBEI DER ANTIKOERPER ODER DAS FRAGMENT DAVON HUMANEN IL-17 REZEPTOR A BINDET; INSBESONDERE EIN ANTIKOERPER, UMFASSEND DIE SEQUENZEN DER VARIABLEN REGION DER LEICHTEN UND SCHWEREN KETTE NACH EP-B1-2076541 ANS; REGISTRATION NO/DATE: EU/1/6/1155/001-002 20170717

Market Dynamics and Financial Trajectory for Brodalumab

Last updated: February 20, 2026

Brodalumab, a monoclonal antibody targeting the interleukin-17 receptor A (IL-17RA), competes within the psoriasis biologics segment, facing competition from agents like secukinumab and ixekizumab. Its market outlook hinges on efficacy, safety profile, regulatory status, and competitive landscape.

Regulatory Status and Approval Timeline

• Approved in the United States by the FDA in February 2017 for moderate-to-severe plaque psoriasis.
• Approved in Japan in 2018.
• Approved in the European Union in 2017.

Approval conditions impact market penetration and geographic expansion, influencing revenue potential.

Market Position and Competitive Landscape

Drug Name	Target	Year Approved	Indications	Market Share (2022, estimated)
Brodalumab	IL-17RA (IL-17 receptor)	2017 (US)	Psoriasis, psoriatic arthritis (off-label)	~5-10% in the US psoriasis segment
Secukinumab	IL-17A	2015	Psoriasis, psoriatic arthritis, AS	~50-55%
Ixekizumab	IL-17A	2016	Psoriasis, psoriatic arthritis, AS	~20-25%
Ustekinumab	IL-12/23	2009	Psoriasis, psoriatic arthritis, CD	~15%

Brodalumab’s distinct mechanism offers an alternative for patients unresponsive or intolerant to other IL-17 inhibitors.

Market Drivers

• Increasing prevalence of psoriasis worldwide, projected to reach 125 million cases by 2030 [1].
• Rising demand for biologic therapies driven by their superior efficacy over traditional systemic treatments.
• Insurance coverage expanding reimbursement for biologic drugs.

Challenges and Market Restraints

• Safety concerns: Reports of suicidal ideation led the FDA to include boxed warnings, affecting prescribing patterns.
• Competitive pressure: Established drugs like secukinumab dominate, constraining growth.
• Pricing pressures: Increasing cost-containment efforts, especially in Europe and emerging markets.
• Off-label uses remain limited, restricting revenue streams beyond primary indications.

Revenue Projections

Year	Estimated Brodalumab Revenue ($ millions)	Assumptions
2023	150-200	Moderate growth, new markets opening, stable uptake in approved regions
2025	250-350	Expansion into additional indications; increased market share among biologics competitors
2030	400-600	Expanded geographic footprint and potential label expansion, assuming continued safety management

Greater adoption hinges on demonstrated safety improvements, label expansion, and competitive positioning.

Investment and R&D Outlook

• Otsuka Pharma and AstraZeneca initially developed brodalumab collaboratively.
• Ongoing trials explore other indications: axial spondyloarthritis and Crohn’s disease.
• Potential for new formulation development, including self-injection devices, could enhance adherence.

Key Market Factors Summary

• Brodalumab’s unique IL-17RA targeting positions it as an alternative for difficult-to-treat psoriasis cases.
• Market growth driven by psoriasis prevalence and biologic uptake; however, growth is challenged by safety signals and competition.
• Revenue trajectory remains modest, dependent on survival of its safety profile, regulatory approvals, and market penetration.

Key Takeaways

• Brodalumab entered the psoriasis market in 2017 and faces strong competition, mainly from IL-17A inhibitors.
• Safety concerns have limited its growth potential but have not halted market access or approval in major regions.
• Revenue growth is projected to remain moderate, with potential gains from expansion into other inflammatory diseases.
• The drug’s positioning as an alternative therapy makes it valuable among biologic options, especially for non-responders.
• Future success depends on ongoing clinical trials, safety management, and market adoption strategies.

FAQs

1. How does brodalumab differ from other IL-17 inhibitors?
It targets the IL-17 receptor A, blocking multiple IL-17 cytokines, unlike secukinumab and ixekizumab, which target IL-17A alone.

2. What are the main safety concerns for brodalumab?
The drug has been associated with reports of suicidal ideation, leading to boxed warnings from regulators, affecting prescribing.

3. Is brodalumab approved for conditions beyond psoriasis?
Currently, approved solely for psoriasis; ongoing trials for psoriatic arthritis, axial spondyloarthritis, and Crohn’s disease.

4. What factors limit brodalumab’s market growth?
Safety profile worries, competition from established IL-17A inhibitors, and price pressures limit its expansion.

5. What is the potential for future market expansion?
Developments in label indications, improved safety data, and geographic expansion could increase revenue.

---

References

[1] World Health Organization. (2021). Global report on psoriasis prevalence.