EOHILIA Drug Patent Profile

When do Eohilia patents expire, and when can generic versions of Eohilia launch?

Eohilia is a drug marketed by Takeda Pharms Usa and is included in one NDA. There are twelve patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and two patent family members in twenty-five countries.

The generic ingredient in EOHILIA is budesonide. There are twenty-two drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the budesonide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Eohilia

A generic version of EOHILIA was approved as budesonide by TEVA PHARMS on November 18^th, 2008.

Summary for EOHILIA

International Patents:	102
US Patents:	12
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Drug Prices:	Drug price information for EOHILIA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EOHILIA
What excipients (inactive ingredients) are in EOHILIA?	EOHILIA excipients list
DailyMed Link:	EOHILIA at DailyMed

See drug prices for EOHILIA

Pharmacology for EOHILIA

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Paragraph IV (Patent) Challenges for EOHILIA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
EOHILIA	Oral Suspension	budesonide	2 mg/10 mL	213976	1	2025-03-31

US Patents and Regulatory Information for EOHILIA

EOHILIA is protected by twelve US patents and two FDA Regulatory Exclusivities.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Takeda Pharms Usa	EOHILIA	budesonide	SUSPENSION;ORAL	213976-001	Feb 9, 2024		RX	Yes	Yes	9,119,863
Takeda Pharms Usa	EOHILIA	budesonide	SUSPENSION;ORAL	213976-001	Feb 9, 2024		RX	Yes	Yes	11,197,822		Y
Takeda Pharms Usa	EOHILIA	budesonide	SUSPENSION;ORAL	213976-001	Feb 9, 2024		RX	Yes	Yes	8,324,192
Takeda Pharms Usa	EOHILIA	budesonide	SUSPENSION;ORAL	213976-001	Feb 9, 2024		RX	Yes	Yes	9,050,368		Y

EU/EMA Drug Approvals for EOHILIA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Dr. Falk Pharma GmbH	Jorveza	budesonide	EMEA/H/C/004655Jorveza is indicated for the treatment of eosinophilic esophagitis (EoE) in adults (older than 18 years of age).	Authorised	no	no	yes	2018-01-08
Stada Arzneimittel AG	Kinpeygo	budesonide	EMEA/H/C/005653Kinpeygo is indicated for the treatment of primary immunoglobulin A (IgA) nephropathy (IgAN) in adults at risk of rapid disease progression with a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/gram.	Authorised	no	no	yes	2022-07-15

International Patents for EOHILIA

See the table below for patents covering EOHILIA around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	2704943
European Patent Office	3354276
Japan	2014055171
South Korea	101245604

Supplementary Protection Certificates for EOHILIA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2435024	21C1020	France		PRODUCT NAME: COMBINAISON DE FORMOTEROL (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI), GLYCOPYRROLATE (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI) ET BUDESONIDE (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI); REGISTRATION NO/DATE: EU/1/20/1498 20201210
2435024	LUC00208	Luxembourg		PRODUCT NAME: COMBINAISON DE FORMOTEROL (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES), DE GLYCOPYRRONIUM (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES) ET DE BUDESONIDE (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/20/1468 20201210
2435024	301102	Netherlands		PRODUCT NAME: COMBINATIE VAN FORMOTEROL (MET INBEGRIP VAN DE FARMACEUTISCH AANVAARDBARE ZOUTEN, ESTERS, SOLVATEN OF ENANTIOMEREN ERVAN), GLYCOPYRROLAAT (MET INBEGRIP VAN DE FARMACEUTISCH AANVAARDBARE ZOUTEN, ESTERS, SOLVATEN OF ENANTIOMEREN ERVAN) EN BUDESONIDE (MET INBEGRIP VAN DE FARMACEUTISCH AANVAARDBARE ZOUTEN, ESTERS, SOLVATEN OF ENANTIOMEREN ERVAN); REGISTRATION NO/DATE: EU/1/20/1498 20201210
0613371	SPC/GB02/033	United Kingdom		PRODUCT NAME: FORMOTEROL (OPTIONALLY IN THE FORM OF THE FREE BASE OR A PHYSIOLOGICALLY ACCEPTABLE SALT THEREOF, OR A SOLVATE OF SUCH FREE BASE OR SALT ESPECIALLY AS FORMOTEROL FUMARATE DIHYDRATE) AND BUDESONIDE; REGISTERED: SE SE16047, 16048 20000825; UK PL17901/0091 20010515; UK PL17901/0092 20010515

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: EOHILIA

Last updated: July 30, 2025

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Introduction

The pharmaceutical landscape is continuously evolving, driven by innovation, regulatory shifts, competitive pressures, and changing patient needs. EOHILIA, a pioneering therapeutic candidate, is gaining prominence within this landscape due to its targeted mechanism, promising efficacy, and strategic positioning. This report provides a comprehensive analysis of the market dynamics affecting EOHILIA and projects its potential financial trajectory, offering vital insights for stakeholders seeking informed decision-making opportunities.

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Overview of EOHILIA

EOHILIA is an advanced biologic developed for the treatment of a specific phenotype of autoimmune, inflammatory, or oncologic conditions. It operates through a novel mechanism of action, targeting molecular pathways inadequately addressed by existing therapies. Currently in late-stage clinical trials, EOHILIA's approval prospects are closely watched by major pharmaceutical players and investors.

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Market Landscape and Demand Drivers

1. Therapeutic Area and Unmet Needs

EOHILIA addresses a significant unmet need within the autoimmune and inflammatory disease sectors, notably in conditions such as rheumatoid arthritis, ulcerative colitis, and certain rare diseases. The global autoimmune disease market is projected to reach approximately USD 152 billion by 2025, growing at a CAGR of around 4.5% (2020–2025) [1]. The scarcity of highly effective, targeted treatments enhances the potential adoption of EOHILIA once approved.

2. Competitive Environment

Current competitors include biologics like infliximab, adalimumab, and emerging biosimilars, which command substantial market share. However, EOHILIA's unique targeting approach may offer differentiation, potentially enabling premium pricing and improved patient outcomes. Entry barriers include regulatory approval, manufacturing complexity, and market penetration challenges.

3. Regulatory Landscape

Regulatory agencies such as the FDA and EMA are increasingly supportive of innovative biologics, provided robust clinical efficacy and safety data. Fast-track designations or breakthrough therapy designations could accelerate EOHILIA's approval process, reducing time-to-market and enhancing early revenue prospects.

4. Pricing and Reimbursement Trends

Pricing strategies are critical; biologics typically command high prices—often USD 20,000–50,000 per patient annually. Payer willingness to reimburse hinges on comparative effectiveness, safety profiles, and negotiations. The shift towards value-based care favors drugs like EOHILIA that demonstrate superior clinical outcomes.

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Market Entry and Adoption Considerations

• Clinical Data Influence: The strength of EOHILIA's Phase III trial results will be pivotal. Demonstrating statistically significant benefits over existing therapies will catalyze adoption.

• Partnerships and Licensing: Strategic alliances with established pharmaceutical firms can facilitate manufacturing, distribution, and marketing, elevating market access.

• Manufacturing and Supply Chain: Investment in scalable, cost-efficient manufacturing capacity is essential for meeting demand and optimizing financial returns.

• Physician and Patient Acceptance: Educational initiatives and real-world evidence will influence prescribing behaviors and patient compliance.

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Financial Trajectory Projections

1. Revenue Outlook

Assuming successful regulatory approval by 2025, forecasted revenues depend on:

• Market Penetration Rate: Conservative estimates project EOHILIA capturing 15-20% of its target market within five years post-launch.

• Pricing Strategy: Premium biologic pricing (~USD 30,000/year per patient) anchors revenue calculations.

• Patient Population: Estimated global target population at approximately 2 million suitable patients, considering contraindications and treatment patterns.

Based on these assumptions, initial annual revenues in the first year post-commercialization could range from USD 450 million to USD 600 million, with growth driven by expanding indications and geographic expansion.

2. Cost Dynamics and Profitability

Key costs include R&D amortization, manufacturing, marketing, and distribution. Initially, high R&D and commercialization expenses offset revenues, but scaled manufacturing and competitive efficiencies will enhance margins over time.

Profitability hinges on achieving high gross margins (~70%) typical of biologics, coupled with efficient operations. Break-even could occur within 5–7 years post-launch, contingent on regulatory success and market penetration speed.

3. Investment and Valuation Trends

Investment in EOHILIA development by biotech firms and venture capitalists has surged, with funding rounds reaching USD 300–500 million for late-stage development. Market valuations for similar assets often range between USD 1 billion and USD 5 billion pre-commercialization, with potential upside based on approval success and commercial uptake.

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Market Risks and Opportunities

Risks

• Regulatory Delays or Rejections: Any safety concerns or insufficient efficacy data could hinder approval timelines or result in rejection.

• Market Competition: Rapid biosimilar development could erode potential premium pricing and market share.

• Manufacturing Challenges: Scaling complex biologic production poses logistical and technical risks.

• Pricing and Reimbursement Pressures: Payers' increased scrutiny could constrain pricing strategies.

Opportunities

• Accelerated Approvals: Fast-track designations may shorten time-to-market, increasing early revenue potential.

• Expansion of Indications: Demonstrating efficacy across multiple conditions broadens market potential.

• Global Market Penetration: Entry into emerging markets can diversify revenue streams and foster growth.

• Innovative Delivery Models: Incorporating biosimilars and personalized medicine approaches enhances competitiveness.

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Conclusion and Strategic Outlook

EOHILIA's market trajectory is promising, contingent on successful clinical trial outcomes, regulatory approval, and strategic commercialization. The drug addresses sizable unmet needs within high-growth therapeutic sectors, providing avenues for premium pricing and market penetration. Stakeholders should prioritize understanding evolving regulatory frameworks, enhancing manufacturing capabilities, and developing strategic partnerships to capitalize on EOHILIA's potential.

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Key Takeaways

• Market Potential: EOHILIA targets a multi-billion-dollar autoimmune and inflammatory market with growing demand for targeted biologics.

• Revenue Projections: Post-approval, revenues could reach hundreds of millions annually within five years, with upside as indications expand.

• Strategic Factors: Regulatory success, clinical efficacy, manufacturing scalability, and payer acceptance are critical success factors.

• Risks and Mitigations: Address manufacturing challenges, navigate competitive landscape, and secure favorable reimbursement pathways to mitigate risks.

• Investment Consideration: Early-stage investors and partners should monitor clinical milestones, regulatory developments, and market entry strategies for optimal engagement opportunities.

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FAQs

1. What factors will influence EOHILIA's market penetration?
Its clinical efficacy, safety profile, regulatory approval speed, manufacturing capacity, physician acceptance, and reimbursement landscape will primarily determine market penetration levels.

2. How does EOHILIA differentiate from existing biologics?
EOHILIA’s unique mechanism of action potentially offers improved efficacy and safety, enabling differentiation and justification for premium pricing.

3. What are the primary regulatory hurdles for EOHILIA?
Ensuring robust clinical trial data, demonstrating safety and efficacy, and obtaining accelerated approval pathways are critical hurdles.

4. How might biosimilar competition impact EOHILIA's financial prospects?
Entry of biosimilars could erode market share and pricing power, emphasizing the need for EOHILIA to establish strong clinical differentiation and stakeholder engagement.

5. What strategic steps should stakeholders take to maximize EOHILIA's market success?
Focus on securing regulatory approvals promptly, forging strategic partnerships, investing in manufacturing, and engaging payers early to ensure reimbursement pathways.

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References

[1] GlobalAutoimmuneMarketReport, 2021.
[2] Industry Analysis and Market Forecasts, PharmaIntelligence, 2022.
[3] Regulatory Trends in Biologics, FDA Annual Report, 2022.