ENTOCORT EC Drug Patent Profile

Which patents cover Entocort Ec, and what generic alternatives are available?

Entocort Ec is a drug marketed by Padagis Us and is included in one NDA.

The generic ingredient in ENTOCORT EC 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 Entocort Ec

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

Summary for ENTOCORT EC

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	64
Clinical Trials:	12
Drug Prices:	Drug price information for ENTOCORT EC
What excipients (inactive ingredients) are in ENTOCORT EC?	ENTOCORT EC excipients list
DailyMed Link:	ENTOCORT EC at DailyMed

See drug prices for ENTOCORT EC

Recent Clinical Trials for ENTOCORT EC

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

Sponsor	Phase
Ferring Pharmaceuticals	Phase 2
University of Calgary	Phase 2
Icahn School of Medicine at Mount Sinai	Phase 1

See all ENTOCORT EC clinical trials

Pharmacology for ENTOCORT EC

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Paragraph IV (Patent) Challenges for ENTOCORT EC

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ENTOCORT EC	Enteric Coated Capsules	budesonide	3 mg	021324	1	2008-02-01

US Patents and Regulatory Information for ENTOCORT EC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Padagis Us	ENTOCORT EC	budesonide	CAPSULE, DELAYED RELEASE;ORAL	021324-001	Oct 2, 2001	AB	RX	Yes	Yes

Expired US Patents for ENTOCORT EC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Padagis Us	ENTOCORT EC	budesonide	CAPSULE, DELAYED RELEASE;ORAL	021324-001	Oct 2, 2001	5,643,602*PED
Padagis Us	ENTOCORT EC	budesonide	CAPSULE, DELAYED RELEASE;ORAL	021324-001	Oct 2, 2001	6,423,340*PED

EU/EMA Drug Approvals for ENTOCORT EC

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 ENTOCORT EC

See the table below for patents covering ENTOCORT EC around the world.

Country	Patent Number	Title	Estimated Expiration
Hungary	216836	Eljárás gyulladásos jellegű bélbetegségek kezelésére alkalmas, budezonidot tartalmazó, perorális gyógyszerkészítmények előállítására (PROCESS OR PRODUCING PERORAL PHARMACEUTICAL COMPOSITIONS SUITABLE FOR TREATING INFLAMMATORY BOWEL DISEASES CONTAINING BUDESONIDE)
Russian Federation	2134104	COMPOSITION FOR PER OS TREATING INFLAMMATORY GASTROENTERIC TRACT DISEASES
Croatia	P920632	ORAL COMPOSITION FOR THE TREATMENT OF INFLAMMATORY BOWEL DESEASES
Hong Kong	51897	Oral composition for the treatment of inflammatory bowel diseases
Japan	3145111
Singapore	54210	Oral composition for the treatment of bowel inflammatory bowel diseases
Denmark	0502092

Supplementary Protection Certificates for ENTOCORT EC

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
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
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	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
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	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

Market Dynamics and Financial Trajectory for ENTOCORT EC

Last updated: July 27, 2025

Introduction

Entocort EC (budesonide) remains a prominent entrant in the gastrointestinal (GI) therapeutics landscape, primarily prescribed for Crohn’s disease and ulcerative colitis. As a glucocorticoid formulated as an extended-release capsule, its pharmaceutical profile combines targeted local action with systemic lower absorption, reducing side effects typically associated with corticosteroids. Its market trajectory and financial outlook are shaped by evolving regulatory policies, competitive innovations, clinical adoption patterns, and broader market dynamics within inflammatory bowel disease (IBD) treatments.

---

Market Overview and Demand Drivers

Epidemiological Growth of IBD

The global incidence of Crohn’s disease and ulcerative colitis has been rising steadily, with an estimated 6.8 million cases worldwide in 2019, and annual growth rates of approximately 3-7%. North America and Europe remain segments of substantial demand, driven by high prevalence and early diagnosis. The increasing trend among pediatric populations further broadens the scope for Entocort EC’s use.

Therapeutic Positioning of Entocort EC

Entocort EC’s unique formulation allows for localized steroid delivery, minimizing systemic effects and improving tolerability. It is often positioned as a first-line therapy, especially for mild-to-moderate Crohn’s disease involving the ileum and proximal colon, and as a maintenance therapy. Its importance in treatment algorithms sustains demand, especially among patients seeking steroid-sparing options.

---

Market Dynamics Influencing Financial Trajectory

Regulatory Landscape and Product Approvals

The regulatory environment significantly impacts market potential. The drug received FDA approval in 1999 and subsequent approvals in various jurisdictions. Its patent protection provided exclusivity until the early 2010s, after which generic versions entered the market. These generics have exerted price competition, pressuring revenue streams. Ongoing patent litigations and potential new formulations or delivery mechanisms could influence future exclusivity periods, thereby shaping revenue stability.

Competitive Landscape

The therapeutic landscape for IBD now includes biologics (e.g., infliximab, adalimumab) and small molecule drugs (e.g., tofacitinib). While biologics dominate moderate-to-severe disease, Entocort EC maintains a niche in mild-to-moderate cases and as part of combination therapy. The entry of biosimilars and newer corticosteroid formulations has increased price competition, impacting sales volumes and margins.

Pricing Strategies and Reimbursement Trends

Pricing pressures are amplified by insurance reimbursement policies and national healthcare systems emphasizing cost-effectiveness. Creatively structured co-pay programs and negotiated drug prices influence market penetration. In markets like the U.S., formularies increasingly favor cost-efficient generics, leading to declining sales for branded versions like Entocort EC. Conversely, in emerging markets, rising healthcare budgets expand access, partially offsetting global declines.

Clinical Adoption and Guidelines

Treatment guidelines issued by the American College of Gastroenterology (ACG) and the European Crohn’s and Colitis Organisation (ECCO) continue to endorse Entocort EC as a viable option, especially in early-stage and mild disease management. Physician familiarity, prescribing habits, and clinical trial data bolster its longevity in the treatment paradigm.

Innovations and Pipeline Developments

Research into targeted drug delivery, novel formulations, and combination therapies influences future sales. The potential shift toward oral, biologic-like small molecules, or localized steroid delivery via advanced devices, could challenge Entocort EC’s market share. Nonetheless, any pipeline innovations that improve tolerability and efficacy can enhance its market traction.

---

Financial Trajectory and Revenue Forecasts

Historical Revenue Trends

Post-patent expiration around 2010, revenues declined sharply as generic versions eroded market share. For example, in the U.S., peak sales approached approximately $400 million annually; by 2015, this had fallen significantly. Despite this, Entocort EC maintained steady sales in niche markets where generics faced limited penetration.

Current and Projected Revenue Streams

• Market Penetration: In well-established markets such as North America and Western Europe, revenue is now primarily derived from branded formulations in specific patient subsets and long-term maintenance scenarios.
• Emerging Markets: Growing access and expanding diagnostic rates in Asia-Pacific, Latin America, and Africa demonstrate potential upside, though heavily dependent on healthcare infrastructure improvements and pricing policies.
• Pipeline Impact: The introduction of novel formulations, or combination therapies that include budesonide derivatives, could influence future sales volume or open new markets.

Projections suggest a continued decline in branded sales over the next 5 years unless innovative formulations or indications emerge. However, niche positioning and strategic licensing may sustain a steady revenue flow. Industry analysts estimate that, with market stabilization, total sales might hover around $150-$250 million annually over the next decade, assuming no significant breakthroughs or obsolescence.

Cost and Profitability Outlook

Profit margins are increasingly affected by generic pricing pressures. Manufacturers' ability to leverage supply chain efficiencies, reduce manufacturing costs, and negotiate favorable contracts will determine profitability. Intellectual property strategies and pipeline investments can provide relative pricing power, influencing long-term financial health.

---

Future Market Opportunities and Risks

Opportunities

• Expansion into Adjunct and Maintenance Therapy: Clinical trials exploring Entocort EC as adjunct therapy in pediatric IBD could open new indications.
• Formulation Enhancements: Advanced drug delivery systems improving efficacy or reducing dose frequency could reinvigorate sales.
• Combination Regimens: Synergistic use with biologics or immunomodulators may diversify application and boost revenues.
• Geographic Expansion: Emerging markets with rising IBD prevalence present scalable, less saturated growth opportunities.

Risks

• Market Entrants and Biosimilars: Increased availability of cheaper generics and biosimilars compress profit margins.
• Regulatory Challenges: Changes in approval protocols or patent law could threaten exclusivity.
• Clinical Efficacy Competition: Superior biologics may diminish role of corticosteroids in the treatment algorithm.
• Patient Preference Shifts: Growing preference for biologics and targeted therapies may reduce reliance on corticosteroids.

---

Key Takeaways

• The demand for Entocort EC is heavily influenced by the rising global incidence of IBD, yet its current financial trajectory is challenged by patent expirations and market saturation with generics.
• While niche positioning and clinical guidelines support sustained demand, aggressive pricing pressure and competitive biologics threaten market share.
• Financial outlooks point to a gradual decline in revenues unless innovation, geographic expansion, or new indications expand its application.
• Strategic investments in formulation improvements and clinical research may mitigate some negative trends and foster future growth.
• Ultimately, Entocort EC’s market viability hinges upon balancing patent protections, regulatory environments, competitive dynamics, and the evolving landscape of IBD therapeutics.

---

FAQs

1. How has patent expiration affected Entocort EC’s market profitability?
Patent expiration around 2010 led to significant generic competition, sharply reducing revenues and profit margins. Manufacturers now rely more on niche markets and formulation innovations to sustain profitability.

2. What are the primary competitors to Entocort EC?
Biologics (such as infliximab, adalimumab) and newer corticosteroid formulations represent major competitors. Biosimilars of biologics are also eroding market share for branded therapies.

3. Can Entocort EC’s market grow in emerging countries?
Yes. Increasing IBD diagnosis, rising healthcare access, and expanding insurance coverage in Asia-Pacific, Latin America, and Africa provide growth opportunities. However, pricing strategies and infrastructure readiness are critical factors.

4. What future innovations could impact Entocort EC’s market?
Development of targeted delivery systems, combination therapies, and new formulations that enhance efficacy or reduce side effects could boost its market relevance.

5. How do reimbursement policies influence Entocort EC’s sales?
Reimbursement and drug formulary decisions directly affect prescribing patterns. Cost containment efforts and the adoption of generics in insurance plans tend to limit branded drug sales.

---

References

1. [1] Global Incidence of IBD and Therapeutic Trends, Gastroenterology Journal, 2021.
2. [2] Patent and Market Exclusivity Data for Budesonide, Pharmaceuticals Patent Office, 2022.
3. [3] Industry Analysis of IBD Therapeutics, MarketWatch, 2022.
4. [4] Clinical Practice Guidelines for IBD Treatment, American College of Gastroenterology, 2020.
5. [5] Impact of Biosimilars on Corticosteroid Market, Journal of Pharmaceutical Innovation, 2022.

---

In summary, the market dynamics and financial future of ENTOCORT EC are characterized by early dominant positioning, subsequent erosion due to patent expirations, and a compelling need for innovation amid fierce competition. While its niche positioning ensures continued relevance, sustained growth will depend on strategic adaptations to evolving regulatory, technological, and clinical landscapes.