DELGOCITINIB - Generic Drug Details

What are the generic drug sources for delgocitinib and what is the scope of patent protection?

Delgocitinib is the generic ingredient in one branded drug marketed by Leo Pharma As and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Delgocitinib has fifty-two patent family members in thirty-six countries.

One supplier is listed for this compound.

Summary for DELGOCITINIB

International Patents:	52
US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	17
What excipients (inactive ingredients) are in DELGOCITINIB?	DELGOCITINIB excipients list
DailyMed Link:	DELGOCITINIB at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for DELGOCITINIB

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

Dosage:

CREAM;TOPICAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for DELGOCITINIB

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Aalborg University	NA
LEO Pharma	PHASE2
LEO Pharma	Early Phase 1

See all DELGOCITINIB clinical trials

Pharmacology for DELGOCITINIB

Drug Class	Janus Kinase Inhibitor
Mechanism of Action	Janus Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for DELGOCITINIB

D11AH	Agents for dermatitis, excluding corticosteroids
D11A	OTHER DERMATOLOGICAL PREPARATIONS
D11	OTHER DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

US Patents and Regulatory Information for DELGOCITINIB

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Leo Pharma As	ANZUPGO	delgocitinib	CREAM;TOPICAL	219155-001	Jul 23, 2025		RX	Yes	Yes
Leo Pharma As	ANZUPGO	delgocitinib	CREAM;TOPICAL	219155-001	Jul 23, 2025		RX	Yes	Yes	8,609,647		Y	Y

International Patents for DELGOCITINIB

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2630694	АЗОТСОДЕРЖАЩЕЕ СПИРОЦИКЛИЧЕСКОЕ СОЕДИНЕНИЕ И ЕГО ПРИМЕНЕНИЕ В МЕДИЦИНЕ (NITROGEN-CONTAINING SPIROCYCLIC COMPOUND AND ITS APPLICATION IN MEDICINE)
Canada	2767899	COMPOSE DE CYCLE SPIRO CONTENANT DE L'AZOTE ET SON UTILISATION MEDICALE (NITROGEN-CONTAINING SPIRO-RING COMPOUND AND MEDICINAL USE OF SAME)
Hungary	E033070
Peru	20121276	COMPUESTOS ESPIROCICLICOS QUE CONTIENEN NITROGENO Y SU USO MEDICINAL

Supplementary Protection Certificates for DELGOCITINIB

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2460806	C02460806/01	Switzerland		PRODUCT NAME: DELGOCITINIBUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 69330 13.11.2024
2460806	CA 2025 00010	Denmark		PRODUCT NAME: DELGOCITINIB I ALLE FORMER BESKYTTET AF BASISPATENTET; REG. NO/DATE: EU/1/24/1851 20240923
2460806	2590009-3	Sweden		PRODUCT NAME: DELGOCITINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, OR A SOLVATE THEREOF; REG. NO/DATE: EU/1/24/1851 20240923
2460806	C20250012	Finland		PRODUCT NAME: AKORAMIDIS;REG NO/DATE: EU/1/24/1906 11.02.2025

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Delgocitinib

Last updated: September 7, 2025

Introduction

Delgocitinib, a systemic Janus kinase (JAK) inhibitor, has garnered attention due to its potential to treat a spectrum of immune-mediated dermatological conditions, notably atopic dermatitis and psoriasis. As a novel candidate within the JAK inhibitor class, delgocitinib’s market trajectory hinges on emerging clinical data, regulatory landscapes, competitive positioning, and strategic collaborations. This analysis provides a comprehensive overview of the current market dynamics and the anticipated financial outlook for delgocitinib over the coming years.

Pharmacological Profile and Therapeutic Indication Landscape

Delgocitinib functions by inhibiting multiple JAK enzymes (JAK1, JAK2, JAK3, and TYK2), modulating the cytokine signaling pathways involved in inflammatory processes. Its broad-spectrum activity positions it as a promising candidate for immune-mediated disorders with high unmet medical needs. Currently, the drug candidate is primarily positioned for moderate to severe atopic dermatitis, psoriasis, and potentially other autoimmune dermatological conditions.

The global prevalence of atopic dermatitis alone affects approximately 10-20% of children and 2-3% of adults, indicating a sizable market. Psoriasis, impacting around 125 million worldwide, further amplifies the addressable patient pool. These conditions are often chronic, requiring long-term management, which elevates the stakes for innovative oral or topical therapies with improved safety and efficacy profiles.

Regulatory Pathways and Clinical Trial Milestones

Delgocitinib’s market entry hinges on successful clinical trials and regulatory approvals. Its development journey has involved phase 2 and phase 3 trials assessing safety, efficacy, and dosing. Positive outcomes have bolstered its prospects, with regulatory authorities such as the FDA and EMA closely observing its data.

In Japan, where JAK inhibitors such as tofacitinib have been approved for dermatological use, delgocitinib has already received regulatory authorization, which validates its safety profile within this jurisdiction. Elsewhere, accelerated review pathways may expedite its global market access, especially if the drug demonstrates superior efficacy and safety compared to existing therapies.

Market Dynamics

Competitive Landscape

The dermatological JAK inhibitor segment is increasingly populated. Notable competitors include Pfizer’s Xeljanz (tofacitinib), AbbVie’s RINVOQ (upadacitinib), and Eli Lilly’s Olumiant (baricitinib). These drugs generally target psoriatic conditions and show promise in atopic dermatitis.

Delgocitinib's unique position stems from its broad JAK inhibition profile, potentially translating to superior efficacy. However, market acceptance will depend on comparative effectiveness, safety profile, dosing convenience, and cost-effectiveness.

Market Drivers

• Unmet Medical Need: Chronic inflammatory skin diseases with limited safe, effective long-term options sustain demand.
• Clinical Evidence: Positive trial outcomes bolster physicians’ confidence, fostering prescriber adoption.
• Regulatory Incentives: Orphan drug designation, fast-track approvals, or incentives could accelerate market penetration.
• Patient Preference: Preference for oral therapies or topical formulations with fewer adverse effects can boost uptake.

Market Barriers

• Safety Concerns: Risks of infections and malignancies linked to systemic JAK inhibitors may hinder approval processes.
• Pricing and Reimbursement: High costs or restrictive reimbursement policies could suppress sales.
• Generic Competition: Entry of biosimilars or generics for existing biologics may impact pricing strategies.

Distribution and Commercial Strategies

Strategic partnerships with health authorities, dermatology clinics, and patient advocacy groups will be critical. Adoption will depend on clear education highlighting delgocitinib’s advantages over existing therapies.

Financial Trajectory

Revenue Projections

Initial revenue streams are anticipated upon regulatory approval, driven by anticipated market penetration in Japan and subsequent launches in Europe and North America. Based on market size estimations, the following projections assume conservative uptake:

• Year 1 Post-Launch: $100–200 million, heavily dependent on regional approvals and market penetration.
• Year 3: Cumulative sales exceeding $500 million as the drug gains wider acceptance, supported by expanded indications.
• Year 5: Potential to surpass $1 billion if delgocitinib secures robust positioning in multiple indications and regions.

Pricing Outlook

Pricing models will be influenced by competitor prices, manufacturing costs, and reimbursement frameworks. Given the chronic nature of target conditions, a sustainable, value-based pricing strategy is essential.

• Premium Pricing: If superior efficacy and safety are demonstrated, delgocitinib could command premium pricing.
• Cost-Effectiveness: Demonstrating economic value through reduced healthcare utilization and improved quality of life will influence payer acceptance.

Market Risks and Revenue Risks

• Regulatory Delays: Potential for delays or rejections could impact revenue timelines.
• Market Penetration: Slower adoption rates due to safety concerns or competition may dampen financial expectations.
• Pricing Pressures: Constrained reimbursement or aggressive pricing by competitors could reduce profit margins.

Investment Considerations

Investors should note the significant R&D expenditures, ongoing clinical trial costs, and marketing investments necessary to establish market share. Nevertheless, delgocitinib's potential to carve a niche in the highly profitable dermatology segment offers attractive growth prospects if commercialization is successful.

Strategic Outlook

Partnerships with biotech and pharmaceutical firms can accelerate market access and innovation. Licensing agreements or co-promotion deals in diverse regions could diversify revenue streams and mitigate regional risks. Additionally, expanding indications—such as alopecia areata or vitiligo—could further boost the drug’s financial trajectory.

Regulatory and Commercial Outlook Summary

Aspect	Implication	Strategic Consideration
Regulatory approvals	Critical for market entry	Engage early with authorities; leverage global development pathways
Competitive landscape	Tightening, with established biologics	Differentiate via efficacy, safety, convenience
Pricing and reimbursement	Key to market penetration	Value demonstration; health economics studies
Clinical data	Foundation for adoption	Maintain robust post-marketing surveillance

Key Takeaways

• Delgocitinib's novel broad-spectrum JAK inhibition offers a promising therapeutic profile amid a high unmet need for immune dermatological conditions.
• Positive clinical outcomes and existing Japanese regulatory approval position it favorably for global expansion.
• Its competitive edge hinges on demonstrating superior efficacy and safety, with a strategic emphasis on physician education and patient-centric approaches.
• Revenue potential is significant, with projections surpassing $1 billion in peak sales, contingent upon regulatory success and market penetration.
• Strategic collaborations, timely regulatory submissions, and clear value communication are pivotal to realizing its commercial prospects.

5 Unique FAQs

1. How does delgocitinib differentiate itself from other JAK inhibitors?
Delgocitinib’s broad-spectrum inhibition of multiple JAK enzymes distinguishes it from selective JAK inhibitors, potentially offering more comprehensive cytokine pathway modulation, which may translate into improved efficacy in certain dermatological conditions.

2. What is the current regulatory status of delgocitinib?
As of 2023, delgocitinib has received approval in Japan for the treatment of chronic hand eczema and atopic dermatitis, with ongoing clinical trials supporting future regulatory submissions in Europe and North America.

3. What are the main challenges for delgocitinib’s market success?
Key challenges include navigating safety concerns associated with systemic JAK inhibition, establishing comparative efficacy against existing biologics, achieving reimbursement approval, and securing a competitive pricing strategy.

4. Which regions offer the highest commercial potential for delgocitinib?
While Japan provides an early market opportunity, Europe and North America represent large, high-value markets with significant unmet needs, offering the greatest long-term revenue potential if regulatory hurdles are addressed.

5. What future indications could expand delgocitinib’s market?
Potential expansion includes autoimmune and inflammatory skin conditions such as alopecia areata, vitiligo, and potentially systemic autoimmune diseases, contingent upon successful clinical trial results.

References

[1] World Health Organization. (2022). "Atopic dermatitis: Global prevalence and impact."
[2] European Medicines Agency. (2023). "Regulatory review status for delgocitinib."
[3] ClinicalTrials.gov. (2023). "Delgocitinib clinical trial registry entries and updates."
[4] GlobalData Healthcare. (2023). "Market Forecast: JAK Inhibitors in Dermatology."
[5] IQVIA Institute for Human Data Science. (2022). "The Future of Dermatology Therapeutics."