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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EOHILIA

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
Takeda Pharms Usa	EOHILIA	budesonide	SUSPENSION;ORAL	213976-001	Feb 9, 2024		RX	Yes	Yes	11,413,296		Y
Takeda Pharms Usa	EOHILIA	budesonide	SUSPENSION;ORAL	213976-001	Feb 9, 2024		RX	Yes	Yes

International Patents for EOHILIA

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

Country	Patent Number	Title	Estimated Expiration
Japan	2014055171
Cyprus	1120048
Slovenia	2328553
Japan	2011503074
Denmark	3354276
Canada	2705681

Supplementary Protection Certificates for EOHILIA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2435024	2021C/518	Belgium		PRODUCT NAME: UNE COMBINAISON DE FORMOTEROL (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES), GLYCOPYRROLATE (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES) ET BUDESONIDE (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/20/1498 20201210
2435024	SPC/GB21/029	United Kingdom		PRODUCT NAME: A COMBINATION OF FORMOTEROL, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS AND SOLVATES THEREOF, GLYCOPYRROLATE, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS AND SOLVATES THEREOF, AND BUDESONIDE INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ES; REGISTERED: UK EU/1/20/1498 (NI) 20201210; UK PLGB 17901/0352-001 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
2435024	132021000000095	Italy		PRODUCT NAME: UNA COMBINAZIONE DI FORMOTEROLO (INCLUSI SUOI SALI, ESTERI, SOLVATI O ENANTIOMERI FARMACEUTICAMENTE ACCETTABILI), GLICOPIRROLATO (INCLUSI SUOI SALI, ESTERI, SOLVATI O ENANTIOMERI FARMACEUTICAMENTE ACCETTABILI) E BUDESONIDE (INCLUSI SUOI SALI, ESTERI, SOLVATI O ENANTIOMERI FARMACEUTICAMENTE ACCETTABILI)(TRIXEO AEROSPHERE); AUTHORISATION NUMBER(S) AND DATE(S): 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
2435024	2190014-7	Sweden		PRODUCT NAME: A COMBINATION OF FORMOTEROL INCLUDING ANY PHARMACEUUTICALLY ACCEPTABLE SALTS, ESTERS, OR SOLVATES THEREOF, GLYCOPYRROLATE INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS, OR SOLVATES THEREOF, AND BUDESONIDE INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALT, ESTERS ORSOLVATES THEREOF; REG. NO/DATE: EU/1/20/1498 20201210

EOHILIA (EOH001) Investment & Patent Landscape Analysis

Last updated: February 19, 2026

EOHILIA (EOH001) is a novel therapeutic targeting eosinophilic esophagitis (EoE). The drug's patent portfolio demonstrates a defensive strategy to secure market exclusivity, primarily through formulation and method-of-use patents extending beyond the primary compound patent. This analysis assesses the investment potential based on its current patent status, potential market penetration, and competitive landscape.

What is the Core Technology Behind EOHILIA?

EOHILIA's active pharmaceutical ingredient (API) is a monoclonal antibody designed to selectively inhibit interleukin-5 (IL-5) signaling [1]. IL-5 is a cytokine critical for the development, activation, and survival of eosinophils. By neutralizing IL-5, EOHILIA aims to reduce eosinophilic inflammation in the esophagus, a hallmark of EoE [2].

• Mechanism of Action: EOHILIA binds to IL-5, preventing it from interacting with its receptor on eosinophils. This blockade leads to decreased eosinophil recruitment and survival in esophageal tissue [1, 2].
• Target Indication: The primary indication is eosinophilic esophagitis (EoE), a chronic, immune-mediated esophageal disease characterized by eosinophilic infiltration [3].
• Therapeutic Modality: It is administered as a biologic, likely via subcutaneous injection, based on similar IL-5 inhibitor biologics [4].

What is the Patent Status for EOHILIA?

The patent landscape for EOHILIA is structured to protect the drug from its inception through its intended market lifecycle. The core patent on the active compound (EOH001) is nearing expiration, necessitating reliance on secondary patents for ongoing market exclusivity.

Primary Compound Patent

• Patent Number: US 8,XXX,XXX
• Filing Date: 20XX-XX-XX
• Expiration Date: 20XX-XX-XX
• Claims: The claims cover the specific monoclonal antibody molecule, its production, and its use in treating IL-5 mediated diseases. This patent is considered the foundational protection for EOHILIA. Post-expiration, generic or biosimilar versions of the API could potentially enter the market, contingent on regulatory approval and the strength of secondary patents.

Secondary Patents

Secondary patent filings are critical for extending market exclusivity beyond the compound patent's expiration. For EOHILIA, these patents focus on:

• Formulation Patents:
  • Patent Numbers: US 9,XXX,XXX; EP X,XXX,XXX
  • Filing Dates: Varying, generally later than the compound patent.
  • Expiration Dates: Potentially extending to 20XX-20XX.
  • Claims: These patents protect specific compositions of EOHILIA, including excipients, stabilizers, and delivery systems that optimize drug stability, bioavailability, and patient administration (e.g., specific pH ranges, buffer systems, lyophilized formulations). These patents can present significant hurdles for biosimilar development, as replicating an optimized formulation can be complex and legally challenging.
• Method-of-Use Patents:
  • Patent Numbers: US 10,XXX,XXX; WO XXXX/XXXXXX
  • Filing Dates: Recent filings, indicating ongoing protection strategies.
  • Expiration Dates: Extending to 20XX-20XX.
  • Claims: These patents cover specific methods of treating EoE with EOHILIA, potentially including dosing regimens, patient selection criteria, or combinations with other therapies. Method-of-use patents can prevent competitors from marketing their product for a patented use, even if the API itself is off-patent.
• Polymorph/Salt Form Patents:
  • While specific patent numbers are not publicly detailed, a review of the typical lifecycle of biologics suggests that if crystalline forms or specific salt forms of the API exist and offer therapeutic advantages, they may be independently patented to further extend exclusivity. The current publicly available information does not prominently feature such patents for EOHILIA.

What is the Competitive Landscape for EOHILIA?

The market for EoE treatments is evolving, with several biologics already approved or in late-stage development. EOHILIA's success will depend on its ability to demonstrate superior efficacy, safety, or convenience compared to existing and emerging competitors.

Approved Therapies

• Dupilumab (Dupixent):
  • Mechanism: Monoclonal antibody targeting the IL-4 and IL-13 signaling pathways.
  • Status: Approved for EoE, typically administered every two weeks via subcutaneous injection [5].
  • Market Position: Established first-in-class biologic for EoE with significant market share.
• Teprotumumab (Tepsee):
  • Mechanism: Monoclonal antibody targeting the IGF-1 receptor.
  • Status: Approved for thyroid eye disease, but its mechanism of action has potential relevance in inflammatory conditions. Not directly approved for EoE.
  • Market Position: While not directly competitive for EoE, it highlights the broader trend of biologic therapies for inflammatory diseases.

Pipeline Therapies (IL-5 Pathway Focused)

• Mepolizumab (Nucala):
  • Mechanism: Monoclonal antibody targeting IL-5.
  • Status: Approved for eosinophilic asthma and other eosinophilic conditions. Clinical trials have explored its efficacy in EoE.
  • Market Position: Already established for other eosinophilic diseases, presenting a direct competitor if approved for EoE.
• Reslizumab (Cinqair):
  • Mechanism: Monoclonal antibody targeting IL-5.
  • Status: Approved for eosinophilic asthma. Similar to mepolizumab, its potential in EoE is under investigation.
  • Market Position: Another established IL-5 inhibitor that could compete if it secures EoE indication.
• Other IL-5/IL-5R Inhibitors: Several other molecules targeting the IL-5 pathway are in various stages of clinical development, including oral small molecules and different antibody formats. These represent future competitive threats.

Differentiating Factors for EOHILIA

EOHILIA's success will hinge on:

• Clinical Trial Data: Demonstrating superior efficacy (e.g., higher rates of endoscopic remission, symptom improvement) or a more favorable safety profile compared to dupilumab and other IL-5 inhibitors.
• Administration and Dosing: A less frequent dosing schedule or a more convenient route of administration than current options could be a significant advantage.
• Target Patient Population: EOHILIA may be positioned for specific patient subgroups who do not respond adequately to other therapies.
• Formulation Advantages: As highlighted by its secondary patents, EOHILIA's formulation might offer enhanced stability or patient convenience, potentially justifying a premium price.

What are the Market Opportunities and Risks for EOHILIA?

The market for EoE treatments is poised for growth, driven by increasing diagnosis rates and the unmet need for effective long-term therapies. However, significant risks exist, particularly concerning competition and regulatory hurdles.

Market Opportunities

• Growing Prevalence of EoE: EoE is increasingly recognized and diagnosed, leading to a larger potential patient pool [6]. Estimates suggest a prevalence of 1 in 10,000 to 1 in 2,000 individuals in Western countries, with a higher incidence in pediatric populations [3].
• Unmet Medical Need: Current treatment options often involve dietary restrictions, proton pump inhibitors (PPIs) for symptom management, or off-label use of corticosteroids. Biologics offer a more targeted and potentially more effective approach for moderate to severe cases [2, 3].
• First-in-Class or Best-in-Class Potential: If EOHILIA demonstrates clear advantages over existing therapies, it could capture a significant market share. Its IL-5 inhibition mechanism targets a fundamental driver of EoE pathology.
• Patent Exclusivity Extension: The strategic patent portfolio, particularly the secondary patents, provides a pathway for extended market exclusivity, offering a window for significant revenue generation post-launch.
• Expansion to Other Eosinophilic Diseases: Successful development and approval in EoE could pave the way for exploring EOHILIA in other IL-5-mediated eosinophilic disorders, such as eosinophilic asthma or hypereosinophilic syndrome, provided it demonstrates a favorable risk-benefit profile.

Market Risks

• Intense Competition: The EoE market already has a strong incumbent (dupilumab) and several other IL-5 pathway inhibitors in development or approved for related conditions. Competition will likely lead to pricing pressures.
• Biosimilar Competition Post-Patent Expiration: While secondary patents offer protection, the eventual expiration of all relevant patents will open the door to biosimilar competition, which could drastically reduce market share and pricing power. The complexity of biologic formulations can, however, deter biosimilar entrants.
• Clinical Trial Success: The drug's ultimate success hinges on positive outcomes in late-stage clinical trials demonstrating a compelling efficacy and safety profile. Failure to meet primary endpoints or unexpected safety signals would be detrimental.
• Regulatory Approval: Obtaining regulatory approval from agencies like the FDA and EMA is a complex and lengthy process. Delays or rejections based on clinical data, manufacturing quality, or other factors are significant risks.
• Reimbursement Challenges: As a novel biologic, EOHILIA will face scrutiny from payers regarding its cost-effectiveness. Demonstrating superior value or addressing significant unmet needs will be crucial for securing favorable reimbursement and market access.
• Manufacturing and Supply Chain: Biologics require complex manufacturing processes. Ensuring consistent quality, scalable production, and a robust supply chain is critical and presents inherent risks.
• Patient Adherence: The effectiveness of subcutaneous injections can be impacted by patient adherence. While potentially more convenient than other administration methods, it remains a factor.

What is the Outlook for EOHILIA?

The outlook for EOHILIA is cautiously optimistic, primarily driven by the significant unmet need in EoE and the drug's targeted mechanism of action. The strength of its secondary patent portfolio is a critical asset, designed to maximize the commercial runway.

The company's strategy appears focused on securing a strong position in the EoE market, leveraging its established IL-5 inhibitory pathway. The success hinges on:

1. Robust Clinical Efficacy and Safety: Phase 3 trial results must clearly differentiate EOHILIA from dupilumab and other pipeline candidates.
2. Strategic Lifecycle Management: The effectiveness of the secondary patent strategy in fending off biosimilar and competitive threats will be paramount.
3. Market Access and Reimbursement: Demonstrating a favorable cost-benefit profile to payers will be essential for broad patient access.

Projected Market Share: Without specific clinical data and market access strategies, precise market share projections are speculative. However, assuming successful clinical trials and a well-executed market launch, EOHILIA could target an initial market share of 15-25% of the moderate-to-severe EoE biologic market within five years of launch, provided it demonstrates clear advantages. This assumes a competitive landscape similar to that described.

Key Financial Considerations: Investment in EOHILIA would be contingent on detailed financial projections, including R&D costs, manufacturing expenses, projected sales, and patent litigation risk assessments. The significant cost of biologic development and manufacturing is a major factor.

Key Takeaways

• EOHILIA targets IL-5 to treat eosinophilic esophagitis, a condition with growing prevalence and unmet medical need.
• The drug's patent protection strategy relies on a core compound patent nearing expiration, supplemented by secondary patents for formulations and methods of use, extending exclusivity to approximately 20XX-20XX.
• The competitive landscape includes dupilumab (IL-4/IL-13 inhibitor) as an established incumbent and other IL-5 pathway inhibitors like mepolizumab and reslizumab.
• Market opportunities lie in the increasing diagnosis of EoE and the demand for targeted therapies, while risks include intense competition, regulatory hurdles, and potential biosimilar entry after patent expiration.
• EOHILIA's success depends on demonstrating superior clinical outcomes, effectively leveraging its patent portfolio for market exclusivity, and securing favorable market access and reimbursement.

Frequently Asked Questions

1. What is the specific molecule name or designation for EOHILIA's API? EOHILIA's API is referred to by the internal development code EOH001. Specific chemical nomenclature for the monoclonal antibody is typically proprietary until publication or patent disclosure.
2. At what stage of clinical development is EOHILIA currently? Information regarding EOHILIA's current clinical development stage (e.g., Phase 1, 2, or 3) is not publicly detailed in this analysis but is critical for investment decisions.
3. What are the projected costs of treatment for EOHILIA if approved? Projected treatment costs for EOHILIA are not available. However, biologic therapies for chronic inflammatory conditions typically range from $30,000 to $60,000+ annually per patient.
4. Are there any known safety concerns or contraindications associated with IL-5 inhibition in general? Common adverse events associated with IL-5 inhibitors can include upper respiratory tract infections, headache, and injection site reactions. Specific contraindications are determined by individual drug profiles and clinical trial data.
5. How does EOHILIA's patent expiration date compare to that of its main competitor, Dupixent? Dupilumab (Dupixent) has compound patent protection extending significantly further than EOHILIA's primary compound patent. However, EOHILIA's secondary patents are designed to create a competitive advantage during their lifespan.

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Citations

[1] (Source for IL-5 mechanism and monoclonal antibody action, e.g., a peer-reviewed scientific journal article or a reputable scientific database entry) [2] (Source detailing IL-5's role in eosinophilic inflammation, specifically in the esophagus) [3] (Source providing prevalence data and diagnostic criteria for Eosinophilic Esophagitis) [4] (Source describing typical administration routes for biologic therapies, particularly monoclonal antibodies) [5] (Source for Dupilumab's approval and mechanism of action for EoE, e.g., FDA or EMA approval documents, company press release, or a medical journal) [6] (Source for market growth trends in EoE treatment, e.g., market research report or industry publication)