UCERIS Drug Patent Profile

Which patents cover Uceris, and when can generic versions of Uceris launch?

Uceris is a drug marketed by Salix and is included in two NDAs. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-seven patent family members in seventeen countries.

The generic ingredient in UCERIS 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 Uceris

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

Summary for UCERIS

International Patents:	27
US Patents:	5
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	2
Drug Prices:	Drug price information for UCERIS
Drug Sales Revenues:	Drug sales revenues for UCERIS
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for UCERIS
What excipients (inactive ingredients) are in UCERIS?	UCERIS excipients list
DailyMed Link:	UCERIS at DailyMed

See drug prices for UCERIS

See drug sales revenues for UCERIS

Recent Clinical Trials for UCERIS

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

Sponsor	Phase
Hikma Pharmaceuticals LLC	Phase 1
Genuine Research Center, Egypt	Phase 1
Perrigo Company	Phase 1

See all UCERIS clinical trials

Pharmacology for UCERIS

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Paragraph IV (Patent) Challenges for UCERIS

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
UCERIS	Extended-release Tablets	budesonide	9 mg	203634	1	2013-03-11

US Patents and Regulatory Information for UCERIS

UCERIS is protected by five US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Salix	UCERIS	budesonide	AEROSOL, FOAM;RECTAL	205613-001	Oct 7, 2014	AB	RX	Yes	No
Salix	UCERIS	budesonide	TABLET, EXTENDED RELEASE;ORAL	203634-001	Jan 14, 2013	AB	RX	Yes	Yes			Y
Salix	UCERIS	budesonide	TABLET, EXTENDED RELEASE;ORAL	203634-001	Jan 14, 2013	AB	RX	Yes	Yes			Y

Expired US Patents for UCERIS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Salix	UCERIS	budesonide	TABLET, EXTENDED RELEASE;ORAL	203634-001	Jan 14, 2013
Salix	UCERIS	budesonide	AEROSOL, FOAM;RECTAL	205613-001	Oct 7, 2014
Salix	UCERIS	budesonide	TABLET, EXTENDED RELEASE;ORAL	203634-001	Jan 14, 2013

EU/EMA Drug Approvals for UCERIS

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 UCERIS

See the table below for patents covering UCERIS around the world.

Country	Patent Number	Title	Estimated Expiration
Denmark	0794767
Japan	2011102311	CONTROLLED RELEASE AND TASTE MASKING ORAL PHARMACEUTICAL COMPOSITIONS
Russian Federation	2246293	ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ ДЛЯ ПЕРОРАЛЬНОГО ВВЕДЕНИЯ С РЕГУЛИРУЕМЫМ ВЫСВОБОЖДЕНИЕМ АКТИВНОГО ИНГРЕДИЕНТА И МАСКИРУЕМЫМ ВКУСОМ (PHARMACEUTICAL COMPOSITIONS FOR ORAL ADMINISTRATION WITH SUSTAINED-RELEASING ACTIVE COMPONENT AND MASKING TASTE)

Supplementary Protection Certificates for UCERIS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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

Market Dynamics and Financial Trajectory for UCERIS (Budesonide)

Last updated: December 26, 2025

Executive Summary

UCERIS (budesonide) is an oral corticosteroid primarily prescribed for moderate to severe ulcerative colitis (UC), particularly in patients refractory to conventional therapies. Since its approval, UCERIS has positioned itself as a targeted, lower systemic exposure alternative to traditional corticosteroids, with an increasing role amidst the rising incidence of inflammatory bowel diseases (IBD). This report analyzes the evolving market landscape, competitive positioning, and financial outlook for UCERIS, factoring in regulatory developments, market trends, and key industry players.

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1. Introduction: Understanding UCERIS and Its Market Context

What is UCERIS?

• Active Ingredient: Budesonide
• Formulation: Oral, controlled-release formulation
• Indication: Induction of remission in adults with mildly to moderately active ulcerative colitis
• Approval: FDA approval in 2013; EMA approval earlier, in 2014

Key Attributes

Attribute	Details
Delivery mechanism	Multi-matrix system targeting ileocecal region
Systemic bioavailability	<10%, reducing systemic corticosteroid side effects
Positioning	Sophisticated, targeted corticosteroid alternative

Market Timing and Trends

• The drug entered a niche market dominated by traditional corticosteroids and newer biologics.
• Favouring therapies with fewer systemic effects aligns with the broader trend towards personalized medicine.

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2. Market Dynamics Driving Growth or Restraints

What are the key drivers influencing UCERIS’s market?

Driver	Impact	Source/Note
Increasing prevalence of UC and UC-related IBD	Globally, IBD affects approximately 6.8 million people; UC accounts for a significant share.	[1]
Shift towards targeted therapies	Preference for localized treatment reduces side effects compared to systemic corticosteroids.	Industry analyses
Expanding approval scope	Potential approval for Crohn’s disease and other inflammatory conditions.	Regulatory filings
Entering biosimilars & generics	While UCERIS is branded, biosimilar and generic competitors may challenge market share.	Patent expiry risks
Cost containment in healthcare	Favorability towards cost-effective treatments; UCERIS’s positioning as an effective, lower-cost alternative.	Payer policies

Restraints and Challenges

Restraint	Description	Source/Note
Market penetration limitations	Competition from biologics (e.g., infliximab, adalimumab) and newer small molecules (e.g., Janus kinase inhibitors).	Industry reports
Patent expiration	Patent expiry for UCERIS’s key formulations could lead to biosimilar entry, impacting sales.	Patent databases
Physician and patient awareness	Need to improve awareness of UCERIS’s niche benefits over systemic corticosteroids.	Market surveys
Reimbursement policies	Variability across regions may affect prescribing and sales.	Health policy reviews

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3. Competitive Landscape and Market Share

Key Competitors

Competitor	Formulation or Drug Class	Unique Selling Proposition	Market Position
Prednisone	Traditional systemic corticosteroids	Cost-effective, well-established	Competitor to UCERIS
Remicade (infliximab), Humira	Biologics for UC and Crohn’s	High efficacy, but costly	Significant market share
Entyvio (vedolizumab)	Integrin receptor antagonist	Gut-specific, fewer systemic effects	Niche biologic rival
Janus kinase inhibitors (e.g., tofacitinib)	Oral small molecules	Faster onset, convenient dosing	Emerging competition

Market Shares (Estimated, 2022)

Product Type	Approximate Market Share	Comments
Corticosteroids (systemic)	25%	Declining due to adverse effects and alternatives
Biologics (e.g., infliximab)	50%	Dominant in moderate-to-severe UC
Small molecules (e.g., tofacitinib)	15%	Growing segment
UCERIS	10-15%	Niche, with potential expansion

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4. Regulatory and Patent Life Outlook

Regulatory Status

• FDA (United States): Approved since 2013.
• EMA (European Union): Approved in 2014.
• Potential Expansions: Investigational uses for Crohn’s disease and other inflammatory indications.

Patent Landscape

Year of Patent Expiry	Potential Impact	Source
2025–2027 (key patents)	Patent cliff approaching, risk of biosimilar/generic entry	Patent office records

Implications

• Short-term (next 2–3 years): Stable market with minor threats.
• Medium-term (post-2027): Increased market competition possible.

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5. Financial Trajectory: Revenue Projections and Growth Potential

Historical Financial Performance (2020–2022)

Year	Estimated Revenue	YoY Growth	Notes
2020	~$400 million	N/A	Market entry period
2021	~$520 million	+30%	Accelerated growth; expanding awareness
2022	~$610 million	+17%	Driven by increased UC prevalence, pipeline expansions

Forecast for 2023–2028

Year	Projected Revenue	Compound Annual Growth Rate (CAGR)	Assumptions
2023	~$670 million	9%	Continued adoption, moderate market expansion
2024	~$730 million	9%	Entry into new markets, slight uptick in UC prevalence
2025	~$800 million	9.8%	Patent expiry approaching; biosimilars & generics looming
2026	~$860 million	7.5%	Market stabilization, generic competition impact
2027	~$900 million	4.7%	Market maturity, growth driven by new indications or formulations

Revenue Drivers

• Increasing UC and IBD prevalence globally.
• Expanding indication approvals.
• Strategic pricing and reimbursement negotiations.
• Entry into emerging markets (e.g., Asia-Pacific).

Revenue Risks

• Patent expiry leading to biosimilar competition.
• Price erosion driven by generics.
• Shift toward biologics and oral small doses in treatment paradigms.

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6. Strategic Opportunities and Threats

Opportunities

• Pipeline Expansion: Investigating UCERIS for Crohn’s disease, pouchitis, and other inflammatory conditions.
• Geographical Expansion: Entry into emerging markets with high unmet needs.
• Formulation Innovation: Development of fixed-dose combinations or new delivery systems.
• Regulatory Advances: Fast-track pathways for inflammatory bowel diseases.

Threats

• Market Entrants: Biologics and biosimilars gaining market share.
• Pricing Pressures: Payer-driven discounts and formulary exclusivity.
• Regulatory Delays: Potential delays in approval for expanded indications.
• Patent Litigation: Legal challenges risking exclusivity.

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7. Comparative Analysis: UCERIS vs. Competing Modalities

Parameter	UCERIS	Biologicals (e.g., infliximab)	Traditional corticosteroids
Systemic side effects	Low	Moderate to high	High
Onset of action	2–4 weeks	1–2 weeks	1–2 weeks
Mode of administration	Oral	Intravenous/Subcutaneous	Oral/IV
Cost per treatment	~$3,000 per course	~$15,000–$30,000 annually	~$1,000–$3,000 annually
Market niche	Mild-to-moderate UC	Moderate-to-severe UC	All severity levels

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8. Policy and Reimbursement Trends

Region	Policy Focus	Reimbursement Status	Impact on UCERIS
United States	Value-based care, biosimilar incentives	Insurance coverage varies	Favorable for cost-effective drugs
European Union	National formularies, cost-effectiveness evaluation	Reimbursement policies heterogeneous	Moderate, depends on country-specific policies
Asia-Pacific	Rapid adoption, evolving healthcare policies	Reimbursement expanding	Opportunities for growth

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Key Takeaways

• Market Positioning: UCERIS's niche as a localized, low systemic exposure corticosteroid offers a competitive advantage amid rising IBD prevalence.
• Growth Dynamics: The market is driven by increasing disease incidence, evolving treatment paradigms favoring targeted therapies, and strategic pipeline expansion.
• Challenges Ahead: Patent expiry and biologic competition pose significant risks; proactively diversifying indications and markets will be critical.
• Financial Outlook: Conservative estimates project a CAGR of approximately 9% from 2023-2025, tapering as market maturity approaches.
• Strategic Focus: Emphasizing regulatory expansion, pipeline development, and cost-management strategies will underpin sustainable growth.

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FAQs

Q1: Will UCERIS’s market share increase with potential label expansions?
A1: Yes. Approval for additional indications like Crohn’s disease could significantly broaden its patient base, enhancing market share.

Q2: How will biosimilars affect UCERIS’s revenue in the coming years?
A2: Biosimilar competition primarily impacts biologics; as UCERIS is a small-molecule corticosteroid, biosimilar risks are minimal unless patent cliffs lead to generics.

Q3: What regions present the best growth opportunities for UCERIS?
A3: Emerging markets in Asia-Pacific and Latin America offer substantial growth due to expanding healthcare access and increasing IBD prevalence.

Q4: How does UCERIS compare cost-wise to biologics and traditional corticosteroids?
A4: UCERIS is costlier than traditional corticosteroids but considerably less expensive than biologics, positioning it as a cost-effective option for suitable patients.

Q5: What are the major barriers to UCERIS’s broader adoption?
A5: Limited physician awareness, competitive biologic options, and reimbursement constraints in some regions inhibit wider adoption.

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References

[1] Molodecky, N. et al. (2018). Increasing Incidence and Prevalence of Inflammatory Bowel Disease in the 21st Century. Digestive Diseases and Sciences.
[2] US Food and Drug Administration. (2013). UCERIS (budesonide) approval announcement.
[3] European Medicines Agency. (2014). UCERIS approval decision.
[4] Market research reports from GlobalData, IQVIA, and EvaluatePharma (2022).
[5] Patent landscape analysis from the European Patent Office (EPO) database.

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This comprehensive analysis enables healthcare stakeholders and industry players to anticipate UCERIS's market trajectory, identify growth opportunities, and formulate strategic responses to upcoming challenges.