Tildrakizumab-asmn - Biologic Drug Details

Summary for tildrakizumab-asmn

Tradenames:	1
High Confidence Patents:	3
Applicants:	1
BLAs:	1
Suppliers: see list	1

Pharmacology for tildrakizumab-asmn

Mechanism of Action	Interleukin-23 Antagonists
Established Pharmacologic Class	Interleukin-23 Antagonist

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 tildrakizumab-asmn Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for tildrakizumab-asmn 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
Sun Pharmaceutical Industries Limited	ILUMYA	tildrakizumab-asmn	Injection	761067	8,293,883	2028-02-21	DrugPatentWatch analysis and company disclosures
Sun Pharmaceutical Industries Limited	ILUMYA	tildrakizumab-asmn	Injection	761067	8,404,813	2031-02-21	DrugPatentWatch analysis and company disclosures
Sun Pharmaceutical Industries Limited	ILUMYA	tildrakizumab-asmn	Injection	761067	9,809,648	2032-12-17	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for tildrakizumab-asmn 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

International Patents for tildrakizumab-asmn

Country	Patent Number	Estimated Expiration
Netherlands	300959
South Africa	200906224
European Patent Office	2059534
Japan	2010518856
Hungary	E042172
Slovenia	2059534

Supplementary Protection Certificates for tildrakizumab-asmn

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
45/2018	Austria		PRODUCT NAME: TILDRAKIZUMAB; REGISTRATION NO/DATE: EU/1/18/1323 (MITTEILUNG) 20180919
401 50017-2018	Slovakia		PRODUCT NAME: TILDRAKIZUMAB; REGISTRATION NO/DATE: EU/1/18/1323 20180919
C02059534/01	Switzerland		PRODUCT NAME: TILDRAKIZUMAB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66784 18.04.2019
673	Finland
2019/003	Ireland		PRODUCT NAME: TILDRAKIZUMAB; REGISTRATION NO/DATE: EU/1/18/1323 20180917
PA2018015	Lithuania		PRODUCT NAME: TILDRAKIZUMABAS; REGISTRATION NO/DATE: EU/1/18/1323 20180917

Market Dynamics and Financial Trajectory for Tildrakizumab-asmn

Last updated: February 23, 2026

What is Tildrakizumab-asmn?

Tildrakizumab-asmn is a monoclonal antibody approved for the treatment of moderate to severe plaque psoriasis. It is a selectively targeting interleukin-23 (IL-23) p19 subunit, which modulates inflammatory processes. Developed by Sun Pharmaceutical Industries under the brand name Ilumya (US) and Ilumetri (EU), it received FDA approval in March 2018 and EMA approval in August 2019.

Market Size and Patient Demand

The psoriasis treatment market is valued around $8.4 billion globally in 2022, with biologic therapies accounting for approximately 75% of sales. The patient population with moderate-to-severe plaque psoriasis exceeds 5 million worldwide.

The global prevalence of psoriasis varies, ranging from 0.5% to 4.8% depending on geographic region. North America and Europe dominate the market due to higher treatment rates and access to biologic therapies.

Competitive Landscape

Tildrakizumab is one of multiple IL-23 inhibitors, competing primarily against:

• Guselkumab (Johnson & Johnson)
• Risankizumab (AbbVie)
• Mirikizumab (Lilly, in development)

It also competes with IL-17 inhibitors (e.g., Secukinumab, Cosentyx) and TNF-alpha inhibitors (e.g., Adalimumab, Humira).

Market Share Dynamics

In 2022, guselkumab and risankizumab led IL-23 market share with approximately 35% and 25%, respectively. Tildrakizumab held an estimated 8%, with room to grow through geographic expansion and formulary inclusion.

Revenue Analysis and Financial Trajectory

Revenue Generation

Sun Pharma reported Ilumya's US sales at approximately $200 million in fiscal year 2022. International revenues contributed an additional estimated $50 million, indicating a total of about $250 million globally.

Growth Drivers

• Expanding indications: potential for use in psoriatic arthritis.
• Geographic expansion: new launches in Asian markets.
• Increasing adoption: through formulary inclusion and clinician education.

Revenue Projections

Based on current uptake trends, the following projections are considered conservative:

Year	Estimated Global Revenue	Growth Rate (YoY)	Comments
2023	$300 million	20%	Continued geographic expansion, real-world data influence
2024	$360 million	20%	Increased market penetration
2025	$450 million	25%	Increased competition, potential new indications

Pricing and Reimbursement

List price per prefilled syringe (~$2,200 in the US), with net prices varying based on negotiations and insurance coverage. Reimbursement challenges exist but are mitigated by its positioning as a subcutaneous biologic with favorable efficacy.

Market Entry Barriers & Opportunities

Barriers

• High development costs for biosimilar competition.
• Strict regulatory and reimbursement landscapes.
• Competition from established IL-23 inhibitors with broader approval and data.

Opportunities

• Fast-growing markets in Asia and Latin America.
• Development of biosimilars, which could reduce pricing.
• Potential patent exclusivity until 2030s, depending on patent extensions.

Regulatory Environment

Tildrakizumab received approval based on pivotal clinical trials:

• reSURFACE 1 & 2: Demonstrated superiority over placebo, comparable to other IL-23 inhibitors.
• Key endpoints included PASI75, PASI90, and skin clearance rates at 12-16 weeks.

Patent protections remain in place until at least mid-2020s, with some patent extensions possible.

Key Takeaways

• Market size valued at over $8 billion, with biologic therapies accounting for the majority.
• Tildrakizumab held around 8% of IL-23 market share in 2022, with potential to expand.
• Global revenue approximately $250 million in 2022, projected to grow at 20-25% annually through 2025.
• Competition from guselkumab and risankizumab is intense but leaves room for niche positioning.
• Opportunities exist in emerging markets, biosimilar development, and new indications.

FAQs

1. What factors influence tildrakizumab's market penetration?
Reimbursement policies, clinician preferences, competitive efficacy profiles, and geographic expansion.

2. How does tildrakizumab compare pricing-wise to competitors?
List price is comparable to other IL-23 inhibitors, around $2,200 per syringe, but net prices vary.

3. Are there biosimilar versions of tildrakizumab?
As of 2023, biosimilars are not yet approved, but industry is progressing toward development.

4. What is the patent outlook for tildrakizumab?
Patent protection extends until at least 2025-2030, depending on extensions and legal challenges.

5. What is the potential for tildrakizumab in indications beyond psoriasis?
Research is ongoing for psoriatic arthritis and other IL-23 mediated diseases; success remains uncertain.

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References

1. Sun Pharmaceutical Industries. (2022). Ilumya (Tildrakizumab-asmn) US Prescribing Information.
2. GlobalData. (2022). Psoriasis Treatment Market Analysis.
3. FDA. (2018). FDA Approval Fact Sheet for Ilumya.
4. European Medicines Agency. (2019). EMA Approval Summary for Ilumetri.
5. IQVIA. (2023). Biologics Sales Data.