SILIQ Drug Profile

Summary for Tradename: SILIQ

High Confidence Patents:	9
Applicants:	1
BLAs:	1

Pharmacology for SILIQ

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. General 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 SILIQ Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for SILIQ Derived from 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	7,767,206	2026-10-02	Company disclosures
Valeant Pharmaceuticals Luxembourg S.à.r.l.	SILIQ	brodalumab	Injection	761032	7,786,284	2026-10-02	Company disclosures
Valeant Pharmaceuticals Luxembourg S.à.r.l.	SILIQ	brodalumab	Injection	761032	7,833,527	2026-10-02	Company disclosures
Valeant Pharmaceuticals Luxembourg S.à.r.l.	SILIQ	brodalumab	Injection	761032	7,939,070	2026-10-02	Company disclosures
Valeant Pharmaceuticals Luxembourg S.à.r.l.	SILIQ	brodalumab	Injection	761032	8,435,518	2030-10-06	Company disclosures
Valeant Pharmaceuticals Luxembourg S.à.r.l.	SILIQ	brodalumab	Injection	761032	8,545,842	2030-06-25	Company disclosures
Valeant Pharmaceuticals Luxembourg S.à.r.l.	SILIQ	brodalumab	Injection	761032	8,790,648	2032-05-15	Company disclosures

3) Low Certainty: US Patents for SILIQ 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	2034-05-15	Patent claims search
Valeant Pharmaceuticals Luxembourg S.à.r.l.	SILIQ	brodalumab	Injection	761032	10,111,968	2032-02-15	Patent claims search
Valeant Pharmaceuticals Luxembourg S.à.r.l.	SILIQ	brodalumab	Injection	761032	10,369,114	2033-03-14	Patent claims search
Valeant Pharmaceuticals Luxembourg S.à.r.l.	SILIQ	brodalumab	Injection	761032	10,590,182	2035-02-24	Patent claims search
Valeant Pharmaceuticals Luxembourg S.à.r.l.	SILIQ	brodalumab	Injection	761032	10,907,186	2040-05-15	Patent claims search
Valeant Pharmaceuticals Luxembourg S.à.r.l.	SILIQ	brodalumab	Injection	761032	10,954,508	2039-07-08	Patent claims search
Valeant Pharmaceuticals Luxembourg S.à.r.l.	SILIQ	brodalumab	Injection	761032	11,052,052	2039-07-31	Patent claims search

Market Dynamics and Financial Trajectory for the Biologic Drug: Siliq

Introduction to Siliq

Siliq, also known as brodalumab, is a human monoclonal antibody that targets interleukin-17A (IL-17A), IL-17F, and other IL-17 isoforms. It is primarily used for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy[2][4].

Market Segment and Growth

The psoriasis drugs market, particularly the segment involving interleukin inhibitors like Siliq, is expected to witness significant growth. This growth is driven by several factors, including the improved safety and efficacy profiles of these drugs compared to other classes, such as TNF inhibitors. The interleukin inhibitors segment, which includes Siliq, is anticipated to register the fastest growth rate over the forecast period due to rising patient adoption and regulatory approvals[1][4].

Regulatory Approvals and Impact

Siliq received FDA approval in February 2017 for the treatment of moderate to severe plaque psoriasis. This approval was a crucial milestone, as it expanded the treatment options available for patients with this chronic condition. Regulatory approvals like this contribute significantly to the market growth of biologic drugs, as they validate the safety and efficacy of these treatments[2].

Competitive Landscape

The psoriasis drugs market is highly competitive, with several biologic drugs targeting different pathways. However, Siliq's unique mechanism of action, targeting IL-17A and IL-17F, sets it apart. Other notable competitors in the interleukin inhibitor segment include Taltz (Ixekizumab), Cosentyx (Secukinumab), and SKYRIZI (Risankizumab). The competitive landscape is further complicated by the impending launch of biosimilars, which could erode the market share of branded biologics[1][4].

Financial Trajectory

The global psoriasis drugs market, which includes Siliq, is projected to reach $63.5 billion by 2031, growing at a CAGR of 8.0% over the forecast period. This growth is largely driven by the increasing prevalence of psoriasis, the approval of new biologics, and the launch of biosimilars. However, the financial trajectory of Siliq specifically may be influenced by the patent expiration of major TNF-inhibitor drugs and the rising adoption of other interleukin inhibitors[4].

Impact of Biosimilars

Biosimilars are expected to play a significant role in the psoriasis drugs market, potentially affecting the sales of branded biologics like Siliq. As more biosimilars are approved and launched, they could erode the market share of branded drugs. By year-end 2019, 17% of the biologics market was already accessible to biosimilars, and this percentage is expected to increase, impacting the financial performance of branded biologics[3][4].

Patient Adoption and Safety Profile

Siliq's improved safety and efficacy profile compared to other treatments has led to increased patient adoption. The drug is particularly beneficial for patients who are intolerant or contraindicated to TNF-α inhibitor therapy, providing an alternative treatment option. This increased adoption is a key driver of the financial growth for Siliq and other interleukin inhibitors[1][4].

Market Exclusivity Dynamics

The market exclusivity dynamics for biologics are complex and differ significantly from those of small molecules. Biologics, including Siliq, enjoy longer market exclusivity periods, but they are also subject to biosimilar competition once their patents expire. This dynamic can significantly impact the financial trajectory of Siliq as biosimilars enter the market[3].

Real-World Impact and Patient Outcomes

The real-world impact of Siliq on patient outcomes is significant. By targeting IL-17A and IL-17F, Siliq provides a targeted therapeutic approach that can lead to better skin clearance and reduced symptoms for patients with moderate to severe plaque psoriasis. This improvement in patient outcomes contributes to the drug's market success and financial performance.

Innovative Technologies and Clinical Trials

The development and approval of biologic drugs like Siliq are often facilitated by innovative technologies such as in silico clinical trials. These technologies can reduce the time and cost associated with bringing a therapeutic treatment to market, potentially enhancing the financial trajectory of drugs by allowing them to reach the market faster and at a lower cost[5].

Key Takeaways

• Growth Potential: The interleukin inhibitors segment, including Siliq, is expected to witness the fastest growth rate due to improved safety and efficacy profiles.
• Regulatory Approvals: FDA approvals and positive opinions from regulatory bodies are crucial for market growth.
• Competitive Landscape: Siliq faces competition from other biologic drugs but stands out due to its unique mechanism of action.
• Biosimilar Impact: The launch of biosimilars could erode the market share of branded biologics like Siliq.
• Patient Adoption: Increased patient adoption due to the drug's safety and efficacy profile drives financial growth.

Frequently Asked Questions

Q: What is Siliq used for? A: Siliq (brodalumab) is used for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.

Q: How does Siliq work? A: Siliq works by targeting interleukin-17A (IL-17A), IL-17F, and other IL-17 isoforms, which are involved in the inflammatory process of psoriasis.

Q: What is the expected growth rate of the psoriasis drugs market? A: The global psoriasis drugs market is expected to grow at a CAGR of 8.0% over the forecast period, reaching $63.5 billion by 2031.

Q: How do biosimilars affect the market for branded biologics like Siliq? A: Biosimilars can erode the market share of branded biologics by offering cheaper alternatives, potentially impacting the financial performance of drugs like Siliq.

Q: What role do regulatory approvals play in the market success of Siliq? A: Regulatory approvals, such as FDA approval, are crucial for validating the safety and efficacy of Siliq, which in turn drives market growth and patient adoption.

Cited Sources:

1. Mordor Intelligence: Psoriasis Drugs Market Size & Share Analysis.
2. MDPI: Trends and Perspectives of Biological Drug Approvals by the FDA.
3. FTC: Biologics Market Dynamics: Setting the Stage for Biosimilars.
4. iHealthcareAnalyst: Global Psoriasis Drugs Market.
5. Reagan-Udall Foundation: In Silico Technologies.