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.

This drug has one hundred and three patent family members in twenty-six countries.

The generic ingredient in EOHILIA is budesonide. There are twenty-two drug master file entries for this compound. Forty-three 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:	103
US Patents:	12
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Applications:	5,828
Drug Prices:	Drug price information 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

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

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/004655 Jorveza 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/005653 Kinpeygo 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
Cyprus	1120048
Denmark	3354276
Japan	2014055171
Japan	2011503074
World Intellectual Property Organization (WIPO)	2010021636

Supplementary Protection Certificates for EOHILIA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	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
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

Market Dynamics and Financial Trajectory for EOHILIA

Introduction to EOHILIA

EOHILIA, developed by Takeda Pharmaceutical Company Limited, is a groundbreaking oral medication approved by the U.S. FDA in February 2024 for the treatment of eosinophilic esophagitis (EoE) in patients aged 11 and older. This approval marks a significant milestone in the management of EoE, a chronic esophageal disease characterized by inflammation and dysfunction of the esophagus.

Market Need and Growth Drivers

The global eosinophilic esophagitis market is experiencing rapid growth, driven by several key factors:

• Increasing Disease Prevalence: EoE affects one in every 2,000 individuals in the U.S., making it more prevalent than Crohn's disease or ulcerative colitis[1].
• Unmet Medical Needs: Prior to EOHILIA's approval, there were limited FDA-approved treatment options for EoE, leading to a substantial unmet need for effective therapies[4].
• Advancements in Treatment: The approval of EOHILIA and other recent treatments, such as Dupixent, has significantly expanded the therapeutic options available for EoE patients[5].

Market Size and Growth Projections

The global eosinophilic esophagitis market is anticipated to grow substantially:

• The market size is estimated to be valued at USD 237.5 million in 2024 and is expected to surpass USD 1,767.2 million by 2031, growing at a CAGR of 33.2% during the forecast period[1].

Competitive Landscape

EOHILIA enters a market with existing competitors but also presents unique advantages:

• Direct Competition: EOHILIA competes directly with Sanofi and Regeneron’s Dupixent, which was approved in 2022 for patients aged 12 and older. However, EOHILIA's oral suspension formulation offers a different therapeutic approach[5].
• Market Penetration: Early adoption data indicates that EOHILIA has made significant strides, with trial rates comparable to Dupixent at a similar post-launch timeframe. Six-month projections suggest a user base comparable to Dupixent’s, with EoE patient share for EOHILIA expected to increase fourfold[3].

Financial Performance and Projections

Takeda's financial performance and projections for EOHILIA are promising:

• Initial Uptake: EOHILIA has seen strong initial uptake, with over half of the surveyed gastroenterologists and allergists already experienced in prescribing it just three months post-launch[3].
• Revenue Growth: Takeda's recent product launches, including EOHILIA, have resulted in strong revenue growth. The company reported a total global revenue of approximately $16.6 billion for the first half of FY2024, with significant growth in the gastroenterology segment[2].
• Future Potential: EOHILIA is expected to continue growing as Takeda expands geographically with recent approvals. The drug's efficacy and improved administration method are key factors driving its adoption and future growth potential[2][3].

Challenges and Considerations

While EOHILIA's market trajectory is positive, there are several challenges and considerations:

• Treatment Label: The 12-week treatment label for EOHILIA raises concerns about how consecutive treatment courses will be managed. Physicians have indicated a preference for continuing treatment immediately after the initial 12-week period, which may involve off-label use or switching to generic budesonide if insurance coverage is an issue[3].
• Regulatory History: EOHILIA's path to FDA approval was fraught with challenges, including a complete response letter and a period of abandonment. However, Takeda's persistence and addressing of FDA concerns ultimately led to the drug's approval[5].

Geographical Dominance

The market for EOHILIA is expected to be dominated by certain regions:

• North America: This region is expected to hold a dominant position due to favourable reimbursement policies and higher patient volumes in hospital pharmacies[1].

Key Market Takeaways

• Rapid Growth: The global eosinophilic esophagitis market is expected to grow at a CAGR of 33.2% from 2024 to 2031.
• Dominant Segments: Corticosteroids, including EOHILIA, are expected to hold a dominant position in the market due to their widespread use as first-line therapy options.
• Distribution Channels: Hospital pharmacies will remain the major revenue generators due to higher patient volumes.
• Geographical Focus: North America will continue to be a key market due to favourable reimbursement policies[1].

Expert Insights and User Feedback

Physicians have expressed positive feedback about EOHILIA:

"I have probably started six or seven patients on EOHILIA. I am excited to have this drug. I have been treating this disease for 15 to 20 years and using topical steroids for most of that time. This is an improvement over what we had, and I am going to use more of it going forward."[3]

Financial Projections and Forecasts

Takeda's overall financial performance and forecasts indicate strong growth:

• The company reported a 13.4% increase in revenue and a 194.0% increase in operating profit for the first half of FY2024 compared to the previous year[2].
• EOHILIA's strong early adoption and growth potential are expected to contribute significantly to Takeda's revenue and profitability in the coming years.

Key Takeaways

• Market Growth: The eosinophilic esophagitis market is expected to grow significantly, driven by increasing disease diagnosis and the development of novel targeted drugs.
• Competitive Advantage: EOHILIA's oral suspension formulation and strong early adoption position it for significant market penetration.
• Financial Performance: Takeda's financial reports indicate strong revenue and profit growth, with EOHILIA expected to be a key contributor.
• Geographical Focus: North America will remain a dominant market due to favourable reimbursement policies.

FAQs

Q: What is EOHILIA, and how is it used in treating eosinophilic esophagitis? A: EOHILIA is an oral suspension of budesonide approved for the treatment of eosinophilic esophagitis (EoE) in patients aged 11 and older. It is administered as a 12-week treatment.

Q: How does EOHILIA compare to other treatments like Dupixent? A: EOHILIA competes with Dupixent but offers a different therapeutic approach as an oral medication. Early adoption data shows EOHILIA's user base is expected to increase fourfold in six months, comparable to Dupixent’s user base[3].

Q: What are the key growth drivers for the eosinophilic esophagitis market? A: The market is driven by increasing disease prevalence, the development of novel targeted drugs, and the lack of effective treatment options prior to recent approvals[1].

Q: Which regions are expected to dominate the market for EOHILIA? A: North America is expected to hold a dominant position due to favourable reimbursement policies and higher patient volumes in hospital pharmacies[1].

Q: What challenges might EOHILIA face in terms of treatment management? A: The 12-week treatment label for EOHILIA raises concerns about how consecutive treatment courses will be managed, potentially involving off-label use or switching to generic budesonide[3].

Cited Sources

1. Coherent Market Insights: "Eosinophilic Esophagitis Market worth $1,767.2 Million by 2031"
2. Takeda Pharmaceuticals: "Business Report: 148th Interim Period"
3. GlobeNewswire: "Takeda's Eohilia Sees Strong Early Adoption and Growth Potential in Eosinophilic Esophagitis"
4. Polaris Market Research: "Eosinophilic Esophagitis Drug Market Size | Industry Report, 2021"
5. HealthEconomics: "FDA Approves Takeda's Eohilia: A Breakthrough Oral Treatment for Eosinophilic Esophagitis"