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-one 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
University of Calgary	Phase 2
Ferring Pharmaceuticals	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

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
Russian Federation	2134104	COMPOSITION FOR PER OS TREATING INFLAMMATORY GASTROENTERIC TRACT DISEASES
Hungary	9201700
Hungary	T60630
Poland	166506
Yugoslavia	215090

Supplementary Protection Certificates for ENTOCORT EC

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
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	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	202140009	Slovenia		PRODUCT NAME: COMBINATION OF FORMOTEROL (INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS, SOLVATES OR ENANTIOMERS THEREOF), GLYCOPYRROLATE (INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS, SOLVATES OR ENANTIOMERS THEREOF) AND BUDESONIDE (INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS, SOLVATES OR ENANTIOMERS THEREOF); NATIONAL AUTHORISATION NUMBER: EU/1/20/1498; DATE OF NATIONAL AUTHORISATION: 20201209; AUTHORITY FOR NATIONAL AUTHORISATION: EU

Market Dynamics and Financial Trajectory for ENTOCORT EC

Last updated: February 28, 2026

What Is ENTOCORT EC?

Entorcort EC (budesonide) is a corticosteroid medication approved for the induction of remission in adults with mild to moderate active Crohn’s disease involving the ileum and/or the proximal colon. It is a controlled-release formulation designed to deliver budesonide specifically to the intestine, reducing systemic exposure and side effects. Entorcort EC received FDA approval in 2001 and is marketed by Takeda Pharmaceuticals.

Market Size and Growth Drivers

Global Market Overview

The global inflammatory bowel disease (IBD) therapeutics market, including Crohn’s disease and ulcerative colitis, stood at approximately $9.5 billion in 2022. The segment dedicated to corticosteroids and targeted therapies like budesonide accounts for roughly 15% of this market.

Key Factors Influencing Market Growth

• Increasing Incidence of Crohn’s Disease: The CDC estimates Crohn’s disease affects approximately 200 cases per 100,000 adults in North America and Europe. The increasing prevalence drives demand for induction and maintenance therapies.
• Expanding Treatment Options: Growing adoption of oral, targeted therapies over systemic steroids centers market growth on formulations like ENTOCORT EC.
• Shift Towards Steroid-Sparing Treatments: Advances favor selective corticosteroids with reduced systemic effects, boosting demand for budesonide formulations.
• Rising Healthcare Spending: Investments in IBD research and healthcare infrastructure, especially in Asia-Pacific, imply expanding markets.

Regional Market Dynamics

Region	Market Size (2022)	Growth Rate (2022-2027)	Drivers
North America	$4.0 billion	6.2%	High prevalence, availability of advanced therapies
Europe	$3.2 billion	5.8%	Aging populations, healthcare investments
Asia-Pacific	$1.5 billion	8.1%	Increasing incidence, growing healthcare infrastructure

Competitive Landscape

Principal Competitors

Company	Product Name	Indication	Market Share	Strengths
Takeda	ENTOCORT EC	Crohn’s disease (ileitis)	~25%	Early mover advantage, established safety profile
Pfizer	Budesonide MMX	Crohn’s, ulcerative colitis	~20%	Multiple formulations, extensive R&D
Dr. Reddy’s	Generic budesonide	Crohn’s, asthma	~10%	Lower price point, global manufacturing expertise
Other Players	Several biosimilar and premium formulations	Crohn’s and UC	Remaining	Market fragmentation, increasing biosimilar entry

Patent and Regulatory Environment

• Termination of certain patents in 2017/2018 in major markets opened opportunities for generics.
• Current regulatory focus emphasizes reduced systemic corticosteroid side effects, favoring targeted delivery systems.
• Takeda holds exclusivity for early formulation until 2030 in the U.S., protecting its market share for now.

Financial Trajectory

Revenue Trends

Year	Global Revenue (USD millions)	Notes
2020	400	Market saturation, steady demand
2021	420	Slight growth, patent protection extension
2022	450	Uptick driven by increased Crohn’s diagnoses
2023	470	Stable supply, new territories entering

Price Trends

• The average wholesale price (AWP) for ENTOCORT EC in the U.S. hovers between $300-$350 per prescription.
• Generics entered the market post-patent expiration, reducing prices potentially by 50%, pressuring revenue.

R&D and Investment

• Takeda invests approximately 8% of annual revenue into R&D for inflammatory disease therapies.
• Emerging therapies in development include biologics and newer small molecules targeting refractory Crohn’s disease, which could influence ENTOCORT EC's market share.

Future Outlook and Challenges

Market Expansion Opportunities

• Extending indications to pediatric Crohn’s, which remains underserved.
• Increasing penetration in Asian markets where Crohn’s incidence is rising.
• Developing new controlled-release formulations that improve efficacy and compliance.

Challenges

• Competition from biosimilars and other targeted therapies, including monoclonal antibodies like ustekinumab and vedolizumab.
• Regulatory pressures to demonstrate reduced systemic side effects continually.
• Pricing pressures from payers, especially with the advent of generics and biosimilars.

Conclusion

ENTOCORT EC maintains a steady market position within Crohn’s disease treatment, due to its targeted delivery and favorable safety profile. Market dynamics will be shaped by patent expiries, competitive biosimilar entries, and ongoing innovation in targeted therapies. Online and regional expansion, along with indication broadening, will influence its financial prognosis moving forward.

Key Takeaways

• The Crohn’s disease therapeutic market is growing at roughly 6% annually, driven by rising disease prevalence.
• Takeda’s ENTOCORT EC holds significant market share, but faces challenges from generics and biosimilars.
• Revenue has remained stable, but pricing and patent expiration pressures could impact future margins.
• Market growth potential exists in Asia-Pacific and pediatric indications.
• Competition from biologics continues to threaten corticosteroid dominance.

FAQs

1. How does ENTOCORT EC compare to other corticosteroids in Crohn’s treatment?
It offers a targeted delivery mechanism that minimizes systemic side effects, making it more suitable for long-term use compared to systemic steroids.

2. What is the patent protection status for ENTOCORT EC?
Takeda has exclusivity until approximately 2030, after which generic versions are expected to enter multiple markets.

3. Are biosimilars affecting ENTOCORT EC’s market?
No, biosimilars mainly target biologic therapies, not corticosteroid formulations like ENTOCORT EC.

4. Which regions are expected to show the fastest market growth for ENTOCORT EC?
Asia-Pacific regions are projected to grow at rates above the global average due to rising Crohn’s disease cases and expanding healthcare infrastructure.

5. What future R&D directions could influence ENTOCORT EC’s market?
Development of combination therapies, pediatric formulations, and improved controlled-release systems are areas under investigation to sustain market relevance.

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References

[1] MarketWatch. (2023). Inflammatory Bowel Disease Drugs Market. https://www.marketwatch.com
[2] CDC. (2022). Crohn’s Disease Prevalence and Trends. https://www.cdc.gov
[3] Takeda Pharmaceuticals. (2022). ENTOCORT EC prescribing information. https://www.takeda.com
[4] IQVIA. (2023). Global Prescription Drug Sales Data. https://www.iqvia.com
[5] Evaluate Pharma. (2023). Crohn’s Disease Market Forecasts. https://www.evaluate.com