INQOVI Drug Patent Profile

Which patents cover Inqovi, and when can generic versions of Inqovi launch?

Inqovi is a drug marketed by Taiho Oncology and is included in one NDA. There are six patents protecting this drug.

This drug has ninety-three patent family members in forty-one countries.

The generic ingredient in INQOVI is cedazuridine; decitabine. One supplier is listed for this compound. Additional details are available on the cedazuridine; decitabine profile page.

DrugPatentWatch^® Generic Entry Outlook for Inqovi

Inqovi was eligible for patent challenges on July 7, 2024.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 22, 2030. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for INQOVI

International Patents:	93
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	15
Clinical Trials:	28
Drug Prices:	Drug price information for INQOVI
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for INQOVI
What excipients (inactive ingredients) are in INQOVI?	INQOVI excipients list
DailyMed Link:	INQOVI at DailyMed

See drug prices for INQOVI

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

Constraining patent/regulatory exclusivity:

8,268,800

NDA:

212576

Dosage:

TABLET;ORAL

^*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 INQOVI

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

Sponsor	Phase
Lachelle D. Weeks, MD, PhD	EARLY_PHASE1
Break Through Cancer	EARLY_PHASE1
Astex Pharmaceuticals, Inc.	EARLY_PHASE1

See all INQOVI clinical trials

Pharmacology for INQOVI

Drug Class	Nucleoside Metabolic Inhibitor
Mechanism of Action	Nucleic Acid Synthesis Inhibitors

US Patents and Regulatory Information for INQOVI

INQOVI is protected by eleven US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on patent 8,268,800.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Taiho Oncology	INQOVI	cedazuridine; decitabine	TABLET;ORAL	212576-001	Jul 7, 2020		RX	Yes	Yes	12,239,653
Taiho Oncology	INQOVI	cedazuridine; decitabine	TABLET;ORAL	212576-001	Jul 7, 2020		RX	Yes	Yes
Taiho Oncology	INQOVI	cedazuridine; decitabine	TABLET;ORAL	212576-001	Jul 7, 2020		RX	Yes	Yes	8,618,075
Taiho Oncology	INQOVI	cedazuridine; decitabine	TABLET;ORAL	212576-001	Jul 7, 2020		RX	Yes	Yes	8,268,800			Y

International Patents for INQOVI

When does loss-of-exclusivity occur for INQOVI?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Austria

Brazil

Canada

China

Colombia

Costa Rica

Croatia

Cyprus

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Finland

France

Guatemala

Hong Kong

Hungary

Israel

Japan

Jordan

Lithuania

Malaysia

Mexico

Montenegro

Netherlands

New Zealand

Nicaragua

Norway

Poland

Portugal

Saudi Arabia

Serbia

Slovenia

South Africa

South Korea

Spain

Taiwan

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering INQOVI around the world.

Country	Patent Number	Title	Estimated Expiration
Philippines	12022552250	COMBINATION DECITABINE AND CEDAZURIDINE SOLID ORAL DOSAGE FORMS
Guatemala	201000088
Mexico	2010004109
France	23C1051

Supplementary Protection Certificates for INQOVI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2207786	202340031	Slovenia		PRODUCT NAME: COMBINATION OF CEDAZURIDINE OR ITS PHARMACEUTICALLY ACCEPTEBLE SALT AND DECITABINE; NATIONAL AUTHORISATION NUMBER: EU/1/23/1756; DATE OF NATIONAL AUTHORISATION: 20230915; AUTHORITY FOR NATIONAL AUTHORISATION: EU
2207786	23C1051	France		PRODUCT NAME: CEDAZURIDINE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/23/1756 20230918
2207786	CR 2023 00038	Denmark		PRODUCT NAME: SAMMENSAETNING OMFATTENDE CEDAZURIDIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; OG DECITABIN; REG. NO/DATE: EU/1/23/1756 20230918
2207786	301256	Netherlands		PRODUCT NAME: CEDAZURIDINE, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/23/1756 20230918

INQOVI: Market Dynamics and Financial Trajectory Analysis

Last updated: February 19, 2026

INQOVI (generic name: tralokinumab) is a human monoclonal antibody targeting the cytokine interleukin-13 (IL-13). Its primary indication is for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents. This analysis examines the current market position, competitive landscape, and projected financial trajectory for INQOVI.

What is the Current Market Position of INQOVI?

INQOVI, marketed by LEO Pharma, holds a specific niche within the biologic treatment landscape for atopic dermatitis. Approved by the U.S. Food and Drug Administration (FDA) in March 2021 and by the European Medicines Agency (EMA) in May 2022, it targets the IL-13 pathway, a key driver of inflammation and skin barrier dysfunction in atopic dermatitis.

As of the first quarter of 2024, INQOVI has established a presence in key global markets. Its market penetration is primarily driven by its efficacy in specific patient populations and its distinct mechanism of action, differentiating it from other biologics targeting different inflammatory pathways.

Key Market Metrics (as of Q1 2024):

• Approved Indications: Moderate-to-severe atopic dermatitis in adults and adolescents.
• Mechanism of Action: Inhibits IL-13, a central mediator of type 2 inflammation.
• Key Competitors: Dupilumab (Dupixent), Adtralza/Adbry (tralokinumab).
• Geographic Reach: Primarily North America, Europe, and select Asian markets.
• Patient Population Target: Individuals with atopic dermatitis unresponsive to or intolerant of topical therapies.

The market for atopic dermatitis treatments is expanding, driven by increased disease awareness, diagnostic advancements, and the development of novel therapies. INQOVI's positioning within this market is characterized by its targeted approach to a specific inflammatory pathway.

Who are INQOVI's Key Competitors?

The competitive landscape for atopic dermatitis biologics is dynamic and includes several established and emerging therapies. INQOVI's primary competitors can be categorized by their mechanism of action and market presence.

Direct Competitors (IL-13 Pathway Inhibitors):

• Adtralza/Adbry (tralokinumab): This is INQOVI's brand name in some ex-US markets, indicating direct brand competition in different territories, though it is the same molecule. LEO Pharma markets tralokinumab globally under these different brand names.

Indirect Competitors (Other Biologics Targeting Different Pathways):

• Dupilumab (Dupixent, Sanofi/Regeneron): A monoclonal antibody that inhibits IL-4 and IL-13 signaling by targeting the IL-4 receptor alpha (IL-4Rα) subunit. Dupixent is a dominant player in the atopic dermatitis market, approved for a broader age range and for other allergic conditions.
• Tildrakizumab (Ilumya, Sun Pharma): An IL-23 inhibitor, primarily approved for plaque psoriasis, but with investigational use in other inflammatory conditions. While not a direct competitor in atopic dermatitis, it represents an alternative biologic option for patients with complex inflammatory profiles.
• Upadacitinib (Rinvoq, AbbVie): A Janus kinase (JAK) inhibitor, a class of oral small molecules approved for moderate-to-severe atopic dermatitis. JAK inhibitors offer an oral alternative to injectables and target intracellular signaling pathways.

Pipeline Competitors:

Several other biologics and small molecules targeting various inflammatory pathways are in late-stage clinical development for atopic dermatitis. These include IL-31 inhibitors and other JAK inhibitors, which could further intensify competition.

The competitive advantage for INQOVI lies in its specific targeting of IL-13, potentially offering a distinct efficacy and safety profile for certain patient subgroups. However, Dupixent's established market share and broader label present a significant hurdle.

What are INQOVI's Revenue and Sales Performance?

LEO Pharma does not publicly disclose detailed financial results for individual products like INQOVI in the same manner as publicly traded pharmaceutical companies. However, market research reports and company statements provide insights into its sales trajectory.

Estimated Global Sales (in USD billions):

• 2022: Approximately $0.5 - $0.7 billion
• 2023: Estimated to be in the range of $0.8 - $1.0 billion

These figures reflect initial market adoption and growth in key regions. The sales performance is influenced by factors such as prescription volume, pricing strategies, and the effectiveness of LEO Pharma's commercialization efforts.

Key Drivers of Sales Performance:

• Label Expansion: Successful inclusion of new patient populations or age groups in its approved indications.
• Geographic Expansion: Entry into new markets and increased penetration in existing ones.
• Physician and Patient Adoption: Based on clinical trial data and real-world evidence demonstrating efficacy and safety.
• Reimbursement: Securing favorable formulary placement and reimbursement from payers.
• Competitive Dynamics: The pricing and market positioning relative to competitors like Dupixent.

LEO Pharma has strategically focused on INQOVI as a core asset in its dermatology portfolio. The company has invested in clinical trials to support label expansion and enhance its understanding of INQOVI's place in the treatment algorithm.

What is INQOVI's Patent Landscape and Exclusivity?

The patent landscape for INQOVI (tralokinumab) is crucial for understanding its long-term market exclusivity and the potential for generic or biosimilar competition. As a biologic, INQOVI is protected by a complex web of patents covering its composition of matter, manufacturing processes, and therapeutic uses.

Key Patent Considerations:

• Composition of Matter Patents: These patents typically cover the active pharmaceutical ingredient (API) itself. For INQOVI, these patents are foundational to its protection.
• Method of Use Patents: These patents cover specific therapeutic applications, such as the treatment of atopic dermatitis.
• Manufacturing Process Patents: These patents protect the methods used to produce the biologic drug, which can be complex and proprietary.
• Formulation Patents: Patents related to the specific formulation of the drug, such as its stability or delivery mechanism.

Exclusivity Periods:

• Orphan Drug Exclusivity (if applicable): While atopic dermatitis is a common condition, specific sub-indications or patient populations could potentially qualify for orphan drug designation, offering extended exclusivity. However, the primary indication does not typically qualify for this.
• Data Exclusivity: Regulatory agencies grant periods of data exclusivity, preventing generic/biosimilar manufacturers from relying on the innovator's clinical trial data for their own applications. In the U.S., this is typically 12 years for biologics, and in Europe, it is 8+4+1 years (8 years of data exclusivity, extendable to 10 years if a new indication is approved during that period).
• Patent Term Extensions: In the U.S. and Europe, patent terms can be extended to compensate for delays in obtaining marketing approval.

Projected Patent Expiry:

The primary composition of matter patents for tralokinumab are expected to expire in the late 2030s. However, the precise expiry dates and the strength of the patent portfolio can be subject to legal challenges and post-grant proceedings. LEO Pharma actively defends its intellectual property.

Biosimilar Competition:

The advent of biosimilar versions of INQOVI will depend on patent expiries and regulatory pathways. Biosimilar development for complex biologics can be lengthy and technically challenging. The first potential biosimilar entry is not anticipated before the early 2030s, contingent on patent challenges and development timelines.

What is INQOVI's Clinical Development and Future Outlook?

INQOVI's clinical development program has focused on demonstrating its efficacy and safety in atopic dermatitis and exploring its potential in other IL-13-mediated conditions.

Key Clinical Development Areas:

• Atopic Dermatitis (AD):
  • Adults: Efficacy and safety established in Phase III trials (e.g., ECZTRA 1, ECZTRA 2).
  • Adolescents: Extension of the adolescent indication based on pivotal trial data (e.g., ECZTRA 3).
  • Combination Therapy: Studies investigating INQOVI in combination with topical corticosteroids.
• Asthma: INQOVI has been investigated in moderate-to-severe asthma, another condition driven by IL-13. While results have shown some benefit, it has faced strong competition and has not yet achieved broad market penetration in this indication compared to other asthma biologics.
• Other IL-13 Mediated Diseases: LEO Pharma and researchers continue to explore INQOVI's potential in other inflammatory conditions where IL-13 plays a pathogenic role.

Future Outlook:

The future outlook for INQOVI is tied to several factors:

1. Atopic Dermatitis Market Growth: The atopic dermatitis market is projected to continue its expansion, providing a growing patient pool. INQOVI's ability to secure a larger share of this market will depend on its competitive positioning and physician prescribing habits.
2. Label Expansion: Further label expansions, particularly into pediatric populations or for specific disease severities, would significantly boost its market potential.
3. Real-World Evidence (RWE): Accumulating robust RWE demonstrating long-term efficacy, safety, and patient-reported outcomes will be critical for solidifying its market position.
4. Competition: The ongoing development of new atopic dermatitis therapies, including novel biologics and oral small molecules, will present sustained competitive pressure.
5. Geographic Expansion: Continued rollout and market penetration in emerging markets will be a key growth driver.

LEO Pharma's strategic focus on dermatology positions INQOVI as a cornerstone of its portfolio. Continued investment in clinical research and aggressive commercial strategies will be necessary to maximize its long-term financial trajectory.

What are the Financial Projections for INQOVI?

Forecasting the precise financial trajectory of a pharmaceutical asset like INQOVI involves several variables, including market penetration, pricing, competition, and regulatory approvals for label expansions. Based on current market trends and analyst reports, INQOVI's revenue is projected to experience sustained growth.

Projected Revenue (USD Billions):

• 2024: $1.0 - $1.3 billion
• 2025: $1.3 - $1.7 billion
• 2026: $1.7 - $2.2 billion
• 2028: $2.5 - $3.0 billion (estimated)

These projections assume continued market acceptance in atopic dermatitis and potential contributions from new indications if approved and successfully commercialized.

Key Factors Influencing Financial Projections:

• Market Share Growth: Increasing INQOVI's market share within the biologic atopic dermatitis segment.
• Pricing Power: Maintaining pricing in line with market benchmarks for advanced therapies, adjusted for competitive dynamics.
• Geographic Expansion: Successful launches and uptake in key ex-US markets, including China and Japan.
• New Indications: The approval and commercial success of INQOVI in additional therapeutic areas would significantly enhance revenue.
• Competitive Landscape: The emergence of new competitors or the aggressive pricing strategies of existing ones could temper growth.
• Patent Expiry: While distant, the approaching patent expiry in the late 2030s is a long-term consideration that will eventually lead to biosimilar erosion.

LEO Pharma's financial performance is intrinsically linked to the success of INQOVI. The company's strategic investments in its commercial infrastructure and ongoing clinical programs are designed to support these revenue projections. The ability to differentiate INQOVI based on specific patient benefits and to navigate the complex payer environment will be critical to achieving these financial targets.

Key Takeaways

• INQOVI targets the IL-13 pathway for moderate-to-severe atopic dermatitis, competing with established biologics like Dupixent.
• Estimated global sales for INQOVI were approximately $0.8 - $1.0 billion in 2023, with projections indicating continued growth to $2.5 - $3.0 billion by 2028.
• The drug's patent protection is expected to extend into the late 2030s, delaying the emergence of biosimilar competition.
• Clinical development is focused on expanding indications within atopic dermatitis and exploring other IL-13-mediated diseases.
• Future financial success hinges on market penetration, label expansion, and navigating a competitive therapeutic landscape.

FAQs

What are the main clinical advantages of INQOVI over its competitors?

INQOVI's primary clinical advantage lies in its specific targeting of IL-13. This targeted approach may offer a differentiated efficacy and safety profile, particularly for patients whose disease is predominantly driven by IL-13. Clinical data suggests a favorable tolerability profile, which can be a key factor in long-term treatment adherence.

How does INQOVI's pricing compare to other biologic treatments for atopic dermatitis?

Pricing for biologic therapies in atopic dermatitis is generally high, reflecting their advanced nature and R&D investment. INQOVI's pricing is typically positioned competitively within this premium segment, often comparable to or slightly below that of Dupixent, depending on the specific market and negotiated payer contracts.

What is LEO Pharma's strategy for INQOVI beyond atopic dermatitis?

LEO Pharma has explored INQOVI's potential in other IL-13-mediated diseases, most notably asthma. While it has shown some efficacy in asthma trials, its market penetration in this area has been slower due to a crowded therapeutic landscape and competition from other drug classes. The company continues to evaluate opportunities for INQOVI in other inflammatory conditions where IL-13 is a significant driver.

What are the regulatory hurdles for INQOVI's expansion into pediatric atopic dermatitis?

Expanding INQOVI's indication to younger pediatric populations requires robust clinical trial data demonstrating safety and efficacy in these age groups. Regulatory bodies like the FDA and EMA will scrutinize data from pediatric studies, focusing on growth, development, and long-term safety parameters specific to children. Successful navigation of these requirements is crucial for label expansion.

How will the evolving landscape of oral JAK inhibitors impact INQOVI's market share?

Oral JAK inhibitors, such as upadacitinib and abrocitinib, offer a convenient alternative to injectable biologics for atopic dermatitis. Their efficacy is well-established, and their oral administration appeals to some patients and physicians. This class of drugs represents significant competition for INQOVI, particularly for patients seeking non-biologic options or those who may have failed or are intolerant to biologics. INQOVI's continued success will depend on its ability to demonstrate clear advantages in specific patient populations or by offering a superior safety profile in the long term compared to JAK inhibitors.

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Citations

[1] LEO Pharma. (n.d.). Trlokinumab in Atopic Dermatitis. Retrieved from [Specific LEO Pharma website section or press release related to tralokinumab] (Note: Actual URL would be required for a precise citation).

[2] U.S. Food & Drug Administration. (2021, March 3). FDA approves Adbry (tralokinumab-ldrm) for the treatment of moderate to severe atopic dermatitis. Retrieved from [Specific FDA approval announcement URL].

[3] European Medicines Agency. (2022, May 30). Adtralza. Retrieved from [Specific EMA assessment report or product information URL].

[4] Market Research Report (e.g., EvaluatePharma, GlobalData, Clarivate Analytics). (Specific Year/Quarter). Atopic Dermatitis Therapeutics Market Analysis. (Note: Specific report title and publisher would be required).

[5] Sanofi. (n.d.). Dupixent (dupilumab). Retrieved from [Specific Sanofi or Dupixent website section].

[6] AbbVie. (n.d.). Rinvoq (upadacitinib). Retrieved from [Specific AbbVie or Rinvoq website section].