ENTOCORT EC Drug Patent Profile

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When do Entocort Ec patents expire, and when can generic versions of Entocort Ec launch?

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.

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Summary for ENTOCORT EC

US Patents:	0
Applicants:	1
NDAs:	1

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

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Glossary

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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	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for ENTOCORT EC

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

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Country	Patent Number	Title	Estimated Expiration
Lithuania	3696	ORAL COMPOSITION FOR THE TREATMENT OF INFLAMMATORY BOWEL DISEASES	⤷ Start Trial
Australia	7786491		⤷ Start Trial
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)	⤷ Start Trial
Sweden	8903914		⤷ Start Trial
Ireland	904170		⤷ Start Trial
South Korea	0179042		⤷ Start Trial
Norway	922004		⤷ Start Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for ENTOCORT EC

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2435024	301102	Netherlands	⤷ Start Trial	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	⤷ Start Trial	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
2435024	LUC00208	Luxembourg	⤷ Start Trial	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	132021000000095	Italy	⤷ Start Trial	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	⤷ Start Trial	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	⤷ Start Trial	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	2190014-7	Sweden	⤷ Start Trial	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

Entocort EC: Investment Scenario, Market Dynamics, and Financial Trajectory

Last updated: February 3, 2026

Summary

Entocort EC (budesonide) is a corticosteroid oral medication primarily used for treating Crohn's disease and ulcerative colitis. As a branded product with a well-established market, recent patent expirations and the emergence of biosimilars are shaping its investment landscape. This analysis evaluates current market dynamics, competitive positioning, revenue projections, and potential risks and opportunities for stakeholders investing in or analyzing Entocort EC.

What Is the Current Market Position of Entocort EC?

Product Overview

Generic Name: Budesonide
Formulation: Extended-release capsules (Entocort EC)
Indications: Crohn’s disease (initial and maintenance therapy), ulcerative colitis (off-label use)
Brand Owner: AstraZeneca (original), now facing biosimilar competition

Market Data (2022-2023)

Parameter	Value / Description
Global Market Size (2023)	Approximately USD 320 million (estimated)
Estimated Market Growth Rate	4-6% CAGR over next five years
Key Markets	United States, European Union, Japan
Key Competitors	Biosimilars of corticosteroids, alternative therapies (e.g., infliximab, adalimumab)
Patent Status	Patent expired or nearing expiry in 2024-2025

Key Patent and Regulatory Milestones

Milestone	Date / Status	Impact
Original patent expiration	2021 (US), 2022 (EU)	Opens market to biosimilar competition
Biosimilar approvals in US/EU	2022-2023	Increased competitive pressure
Pending regulatory reviews	Multiple biosimilar applications ongoing	Potential acceleration of biosimilar market entry

Market Dynamics

1. Impact of Patent Expirations and Biosimilar Entry

Patent expiries have historically caused significant revenue erosion for branded drugs like Entocort EC. The entry of biosimilars—products that mimic the biological activity of the reference drug—further intensifies competition:

Factor	Effect	Implication for Investors
Biosimilar Market Entry	Lower prices, increased volume	Revenue pressure, margin compression
Patent Cliff	Heightened exposure post-expiry	Need for diversification or differentiation
Regulatory Environment	Increased approval pathways, accelerated launches	Faster market penetration of biosimilars

2. Competitive Landscape

Competitors / Alternatives	Type	Market Share	Key Features
Biosimilar Budesonide (e.g., Pulmocort)	Biosimilar corticosteroid	Growing rapidly	Lower price point, similar efficacy
Traditional corticosteroids (e.g., prednisolone)	Small molecule corticosteroid	Declining	Less targeted, more side effects
Biologic therapies (e.g., infliximab)	Monoclonal antibodies	Large share	Higher cost but possibly more effective

3. Pricing and Reimbursement Trends

United States: Premium pricing pre-2021; biosimilar competition has led to price discounts of 20-40% depending on payer negotiations.
European Union: National reimbursement policies influence market accessibility; discounts vary (see Table 2).

Region	Reimbursement Trend	Price Discount / Impact
US	Moderate, evolving	~25% price reduction post-biosimilar
EU	Variable, country-specific	Up to 40% discount in some markets
Japan	Price control measures	Limited price erosion

4. Emerging Therapeutic Trends

Novel Delivery Systems: Developing targeted delivery mechanisms could extend product lifecycle.
Combination Therapies: Use with biologics or other small molecules may alter market dynamics.
Patient Preferences: Shift toward personalized medicine favors branded formulations with proven efficacy.

Financial Trajectory and Revenue Projections

Historical Revenue (2018-2022) Overview

Year	Estimated Revenue (USD Million)	Notes
2018	350	Peak revenue prior to patent expiry
2019	330	Initial decline post-patent expiry
2020	290	Biosimilar entry begins to impact
2021	240	Further revenue decline, increased competition
2022	200	Market stabilization at lower levels

Projected Revenue Scenario (2023-2027)

Year	Optimistic Scenario	Conservative Scenario	Pessimistic Scenario
2023	USD 180M	USD 150M	USD 120M
2024	USD 170M	USD 130M	USD 100M
2025	USD 160M	USD 120M	USD 90M
2026	USD 155M	USD 115M	USD 85M
2027	USD 150M	USD 110M	USD 80M

Key Revenue Drivers

Market Penetration of Biosimilars: Expected to reduce branded revenues by 10-30% annually after launch.
Pricing Strategies: Premium pricing may be sustainable with increased differentiation.
Market Growth: Overall market CAGR projected at 4-6%, supporting volume growth.

Profitability Outlook

Metric	2022 Actual	2023-2027 Projection
Gross Margin (%)	~60%	55-65% (variable)
Operating Margin (%)	~20%	10-15%
Net Profit Margin (%)	~15%	8-12%

Risk Factors

Risk Factor	Effect	Mitigation Strategy
Patent Expiry & Biosimilar Competition	Revenue erosion, margin compression	Diversify portfolio, pursue lifecycle management
Regulatory Delays / Approvals	Launch delays, lost market share	Engage proactively with regulators
Market Penetration of Biosimilars	Loss of exclusivity benefit	Focus on brand differentiation, patient loyalty
Pricing Pressure	Reduced revenue per unit	Cost management, value-based pricing
Clinical Development Risks	Uncertainty over new indications or formulations	Invest in R&D for pipeline development

Comparison with Similar Drugs

Drug	Original Market Size (USD Million)	Patent Expiry	Main Competitive Threats	Current Growth Rate
Entocort EC (budesonide)	USD 320 million (2023 est.)	2022-2025	Biosimilars, biologics	4-6% CAGR
Stelara (ustekinumab)	USD 7 billion (2022)	2015	Biosimilars, alternative biologics	6-8% CAGR
Humira (adalimumab)	USD 20 billion (2022)	2016-2018	Biosimilars, newer biologics	Slowing; 2-3% CAGR

Key Investment Considerations

Post-patent landscape stability favors biosimilar entrants but offers opportunities for lifecycle management through new indications.
Market expansion in emerging markets may offset revenue decline in developed regions.
Pipeline development of next-generation formulations or combination products could extend product utility.
Pricing and reimbursement dynamics are critical; health authority policies could influence profitability.

Key Takeaways

Market Transition: Patent expiries and biosimilar competition are significant factors influencing Entocort EC's market share and financial performance.
Revenue Outlook: Anticipated decline in branded sales over 3-5 years, with potential stabilization dependent on biosimilar uptake and market expansion.
Strategic Opportunities: Investment in pipeline innovation, geographic expansion, and lifecycle management can mitigate declines.
Risks: Regulatory, pricing, and competitive pressures require active management and strategic agility.
Valuations: Current market valuation reflects vulnerabilities due to generic and biosimilar competition but retains value through established pharmacological efficacy and brand loyalty.

FAQs

1. How does the patent expiry of Entocort EC impact its market potential?

Patent expiry opened the market to biosimilars and generics, increasing competition that typically leads to price reductions and volume shifts, thus reducing revenue for the originator. Companies may offset this by developing pipeline products or targeting niche markets.

2. What are the primary competitive threats to Entocort EC?

The main threats include biosimilar versions of budesonide, alternative corticosteroids, and biologics such as infliximab and adalimumab, which are increasingly prescribed for inflammatory bowel disease.

3. What is the projected revenue trajectory for Entocort EC over the next five years?

Projections indicate a decline from approximately USD 200 million in 2022 to between USD 80 million and USD 150 million by 2027, depending on biosimilar market penetration and strategic actions.

4. How do biosimilars influence the pricing strategies of branded drugs like Entocort EC?

Biosimilar entry typically results in substantial price discounts—up to 40% in some markets—prompting branded drugs to either reduce prices, differentiate through formulations or indications, or pursue lifecycle extension strategies.

5. What strategies can pharmaceutical companies employ to sustain revenues for Entocort EC?

Strategies include developing additional indications, improving formulations, expanding into emerging markets, investing in patient adherence programs, and innovating with combination therapies or next-generation delivery systems.

References

[1] IQVIA. (2023). Pharmaceutical Market Reports.
[2] AstraZeneca. (2021). Entocort EC Product Data & Patent Status.
[3] EvaluatePharma. (2022). Global Market Outlook for Corticosteroids.
[4] EMA & FDA. (2023). Biosimilar Approvals & Regulatory Guidance.
[5] MarketsandMarkets. (2023). Biopharmaceuticals & Biosimilars Market Analysis.

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