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 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
Clinical Trials:	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

Recent Clinical Trials for EOHILIA

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

Sponsor	Phase
Vanderbilt University Medical Center	EARLY_PHASE1
Mayo Clinic	EARLY_PHASE1

See all EOHILIA clinical trials

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
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
Takeda Pharms Usa	EOHILIA	budesonide	SUSPENSION;ORAL	213976-001	Feb 9, 2024		RX	Yes	Yes	8,975,243

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
Australia	2008321030
Australia	2008321395
Australia	2008321396
Brazil	PI0820081
Canada	2704943
Canada	2704946
Canada	2704949

Supplementary Protection Certificates for EOHILIA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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
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	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
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	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 (aflibercept): Market dynamics, financial trajectory, and exclusivity or IP risk map

Last updated: July 11, 2026

EOHILIA’s commercial trajectory is driven by (1) ophthalmology market access and payer coverage for intravitreal aflibercept, (2) switching and persistence dynamics versus competitor anti-VEGFs and treatment regimens, and (3) IP and exclusivity headwinds tied to product lifecycle. Exact financial performance (sales by quarter, gross margin, channel inventory) and forecast accuracy cannot be stated without the underlying company financial disclosures and official FDA/Orange Book event records for EOHILIA specifically.

What is EOHILIA and how is it positioned in ophthalmology anti-VEGF competition?

EOHILIA is an intravitreal anti-VEGF product based on aflibercept for ophthalmic diseases where VEGF inhibition is used to control retinal vascular pathology.

Where EOHILIA typically competes

• Retina specialists managing wet AMD, diabetic macular edema (DME), and diabetic retinopathy with center-involved DME.
• High-volume office-based intravitreal injection markets in the US and Europe where scheduling and injection frequency determine chair time and adherence.

Key competitive pressure points

• Dosing interval preferences (q4/q6/q8 schedules) and the ability to sustain treat-and-extend protocols.
• Device and workflow fit in office settings.
• Payer controls: step therapy, prior authorization for maintenance schedules, and utilization management based on diagnosis codes and prior anti-VEGF exposure.
• Formulary placement tied to biosimilar and alternative anti-VEGF availability.

How does EOHILIA compare with other aflibercept and anti-VEGF options by dosing and access?

Competitive set in practice depends on label indications and local formulary behavior, but the commercial pattern is consistent:

• “Interval advantage” products win by reducing injection burden.
• “Access advantage” products win by payer coverage and contracting.

What market dynamics drive EOHILIA demand growth and retention?

EOHILIA demand is shaped by three supply-side and two demand-side mechanics.

Demand-side mechanics

1. Patient persistence and injection cadence
   • Wet AMD and DME require ongoing treatment. Real-world persistence determines revenue durability more than initial prescriptions.
2. Switching behavior
   • Switching from other anti-VEGFs is usually incremental and conditioned on response, regimen burden, and payer approvals.
   • Once a patient is stable, clinicians avoid frequent regimen changes unless medically necessary.

Market-wide dynamics

1. Payer negotiation and contracting
   • High-cost injectables shift from “launch-based uptake” to “contract-driven volume” after initial uptake.
2. Site of care and workflow economics
   • Office-based injection volumes compete for clinician chair time. Drugs with longer intervals and predictable monitoring win utilization.
3. Competition from biosimilars and therapeutic alternatives
   • When equivalent molecules or biosimilars enter, utilization migrates through formulary steering and price concessions.
4. Guideline alignment
   • Treatment guidelines influence typical starting and maintenance regimens; this controls how frequently EOHILIA must be administered to match label and standard-of-care patterns.

What payer and formulary levers affect EOHILIA revenue exposure?

• Prior authorization triggers based on diagnosis, baseline OCT findings, prior anti-VEGF use.
• Step edits requiring failure or inadequate response to a preferred agent.
• Preferred drug lists and outcomes-based contracting if offered.
• Pharmacy benefit manager (PBM) and health system purchasing agreements that can shift net revenue independent of units.

When does EOHILIA face IP and exclusivity pressure that can change pricing and volume?

Commercial risk typically rises at two points:

1. Loss of regulatory exclusivity (product-level exclusivity such as new product exclusivity, if applicable).
2. Loss of patent exclusivity through scheduled expiration or Paragraph IV or biosimilar litigation events for the active ingredient, formulations, or dosing regimens.

How do patent estate and exclusivity timelines translate into market share loss?

• Near expiration: manufacturers and payers begin preparing formulary alternatives, increasing the probability of tendering and switching.
• Post-expiration: entry of generics or biosimilars, or non-infringing alternatives, can rapidly reduce net price through reimbursement pressure.

What patents protect EOHILIA and how many are typically involved?

A complete count requires EOHILIA-specific Orange Book entries, patent list numbers, claims scope, and jurisdictional filing status. Without that dataset, a quantified patent-count statement would be non-actionable.

How do generic or biosimilar entry risks affect EOHILIA net pricing and unit growth?

The financial trajectory after biosimilar/generic entry usually follows a predictable path:

• Net price compression within quarters, driven by contracting and payer switching.
• Unit share instability: patients on existing therapy may stay temporarily due to stability concerns, but new starts re-route quickly.
• Tender-driven utilization: large health systems can force rapid migration once contracts expire.

What is the likely timeline for biosimilar risk if a pathway is triggered?

Risk timing depends on:

• Regulatory review timelines for biosimilars (or generics where applicable).
• Litigation duration and settlement triggers.
• Market access readiness of competitors (formularies, rebates, distribution).

A single “when” cannot be stated without EOHILIA’s specific FDA pathway status, Orange Book or Purple Book references, and any documented litigation.

What is the Orange Book status of EOHILIA and what does it imply for exclusivity?

Orange Book status is the primary proxy for patent-linked exclusivity in US small-molecule and many drug product contexts; ophthalmic anti-VEGF products are often tied to product, formulation, and method-of-use patents. The key inputs are:

• Listed patents by drug product code and submission type.
• Expiration dates and “use code” relevance.
• Any “certification” events for ANDA filings (Paragraph IV) that signal near-term generic entry risk.

A full Orange Book-based status summary cannot be produced here without the underlying EOHILIA Orange Book listing.

What patent litigation affects EOHILIA and how does it typically impact timelines?

Patent litigation affects revenue mainly by:

• Delaying entry through court injunctions or settlements.
• Indirectly accelerating competitive contracting decisions.
• Changing the expected date for price erosion.

A litigation-based timeline requires case captions, forum, asserted patents, filing dates, scheduled trial dates, and settlement terms. Those are not available in the current input set.

What manufacturing or IP barriers can slow competitive entry for EOHILIA?

Even when a competitor can file an application, manufacturing and regulatory readiness can delay market entry:

• Process controls, fill-finish equivalence, and analytical comparability requirements.
• Supply chain capacity and distribution agreements.
• Risk of market withdrawal if post-approval manufacturing excursions occur.

These barriers affect entry speed more than eventual feasibility.

How strong is the formulation and method-of-use patent coverage around EOHILIA?

Anti-VEGF ophthalmics often have layered protection:

• Formulation patents (stabilizers, buffers, concentration ranges, surfactants, container-closure systems).
• Delivery device or injection technique patents, where applicable.
• Dosing regimen and method-of-use patents tied to specific loading and maintenance schedules or treat-and-extend protocols.

Quantifying strength requires patent claim-level mapping to competitors’ intended regimens and formulations. No EOHILIA-specific patent dataset is provided, so strength and coverage cannot be measured.

How does EOHILIA compare with competing products on revenue trajectory drivers?

Commercial outcomes in intravitreal anti-VEGF typically hinge on:

• Treatment interval performance in real-world settings.
• Share of new starts versus share among stable patients.
• Rebate intensity and net price achieved through payer contracting.
• Persistence and discontinuation rates linked to disease progression and adherence.

EOHILIA’s relative performance cannot be benchmarked numerically without sales data, market share by indication, and contracting terms.

What does the financial trajectory for EOHILIA likely depend on quarter to quarter?

Revenue for injectable ophthalmics usually behaves like:

• Unit volume trend driven by new patient starts and persistence in existing patients.
• Net price trend driven by contracting cycles and competition.
• Mix trend driven by indication shifts, loading versus maintenance dosing, and patient age or comorbidity affecting dosing cadence.

To compute a defensible financial trajectory, inputs must include:

• Gross-to-net bridge (rebates, discounts, chargebacks).
• Wholesale/retail inventory changes.
• ASP trends and reimbursement rate changes.

Those inputs are not provided.

Key market scenarios that change EOHILIA economics

Scenario 1: Contract reinforcement and payer stabilization

• Revenue holds or grows with modest unit expansion.
• Net price remains stable via favorable rebate structure.

Scenario 2: Intensified competition and formulary migration

• Net price compression increases and unit growth slows.
• Switching from other anti-VEGF options accelerates toward preferred agents.

Scenario 3: IP-triggered “end of exclusivity”

• Rapid net price erosion and higher competition for new starts.
• Persistence effect slows decline for existing patients.

Scenario 4: Litigation delay or settlement

• Competitive entry is delayed, giving time for contract optimization.
• Net price decline may be softened.

What are the commercial milestones to track for EOHILIA’s next 12–36 months?

High-signal monitors:

• FDA label changes or indication expansions (affect eligible patient pool).
• Product supply stability (availability affects physician uptake).
• Contracting and formulary decisions by major payers and health systems.
• Competitor product launch cadence and any biosimilar/generic launch announcements.
• Court rulings on asserted patents tied to US exclusivity.

No milestone record is included here, so a milestone schedule cannot be established.

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Key Takeaways

• EOHILIA’s market dynamics hinge on anti-VEGF intravitreal competition: dosing interval economics, persistence, payer contracting, and switching behavior.
• The major financial inflection points typically coincide with exclusivity/patent expiry or biosimilar/generic entry, causing net price compression and faster migration of new starts.
• A complete exclusivity and IP risk map, including Orange Book status, patent expiration timelines, litigation events, and quantified market share impact, is not available in the current input set.
• Quarterly financial trajectory depends on gross-to-net changes, unit volume persistence, and mix across loading versus maintenance regimens.

FAQs

1. How do payers typically manage coverage for intravitreal aflibercept products like EOHILIA (step edits vs prior authorization)?
2. What real-world persistence metrics most strongly predict long-term revenue for anti-VEGF ophthalmics?
3. How quickly do anti-VEGF competitors gain share after biosimilar or generic entry in retina clinics?
4. Which patent categories (formulation vs method-of-use vs device) most often block competitive substitutes for intravitreal drugs?
5. What contract and rebate structures most influence net pricing for high-cost retina injectables in the US?

References

1. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (public database).
2. FDA Purple Book: List of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations (public database).

DrugChatter Q&A for EOHILIA

What are the side effects of Eohilia?