UCERIS Drug Patent Profile

When do Uceris patents expire, 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
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
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	TABLET, EXTENDED RELEASE;ORAL	203634-001	Jan 14, 2013
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
Salix	UCERIS	budesonide	TABLET, EXTENDED RELEASE;ORAL	203634-001	Jan 14, 2013
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
Norway	331642
Japan	5279850
China	1173695
Germany	60005819
Austria	E251449
Canada	2377301
Italy	MI991317	SISTEMI TERAPEUTICI A RILASCIO MODIFICATO PER FORMA FARMACEUTICHE ORALI

Supplementary Protection Certificates for UCERIS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	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	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	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	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 UCERIS (Budesonide) in the Pharmaceutical Sector

Last updated: July 27, 2025

Introduction

UCERIS (budesonide), an oral corticosteroid designed for ulcerative colitis, has carved a significant niche within the gastroenterology market since its FDA approval in 2014. Its unique delivery mechanism and targeted therapeutic profile position it as a leading treatment for mild to moderate ulcerative colitis, influencing market strategies and investment trajectories. This analysis delineates the current market dynamics, competitive landscape, regulatory factors, and forecasted financial trajectory for UCERIS, providing stakeholders with actionable insights.

Market Overview

The global inflammatory bowel disease (IBD) therapeutics market, incorporating ulcerative colitis, stood at approximately USD 7.5 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of around 6.2% through 2030 [1]. UCERIS, a proprietary formulation of budesonide by Dr. Reddy's Laboratories, targets a niche within this expansive market. Its key differentiators include its selective delivery system that minimizes systemic absorption, thereby reducing side effects commonly associated with corticosteroids.

Therapeutic Positioning of UCERIS

UCERIS is indicated for the induction of remission in mildly to moderately active ulcerative colitis. Its oral capsule formulation allows targeted delivery to the colon, optimizing therapeutic outcomes while diminishing adverse cardiovascular, metabolic, and infectious risks linked to systemic corticosteroid therapy [2]. This positions UCERIS favorably compared to systemic steroids, fueling its adoption among clinicians.

Market Dynamics

1. Clinical Efficacy and Safety Profile

Clinical trials demonstrate UCERIS's non-inferiority to systemic corticosteroids with a superior safety profile. The Phase III ULTRA 2 trial confirmed its efficacy in inducing remission, with fewer adverse events and reduced corticosteroid-related side effects [3]. This evidence underscores sustained prescriber confidence and promotes formulary inclusion, bolstering market penetration.

2. Competitive Landscape

UCERIS's primary competition originates from other corticosteroids like prednisolone and hydrocortisone, as well as biologics such as infliximab and adalimumab. While biologics offer higher remission rates for severe cases, UCERIS caters to mild-to-moderate cases, providing an effective, safer, and cost-effective alternative. The competitive advantage hinges on its targeted delivery and favorable safety profile.

3. Regulatory and Reimbursement Environment

Regulatory authorities have recognized the therapeutic niche UCERIS occupies. In the United States, it holds FDA approval, and similar approvals exist or are under review in various international markets. Reimbursement policies favor oral formulations with favorable safety profiles, influencing prescribing patterns. However, pricing pressures and evolving payer strategies necessitate ongoing market assessment.

4. Market Penetration and Adoption

Despite its benefits, UCERIS's market penetration remains modest, constrained by clinician familiarity with biologics and generics' price competitiveness. Efforts to expand dosing indications, such as maintenance therapy or combination treatments, could catalyze broader adoption.

5. Alternative and Emerging Therapies

Emerging therapies targeting the gut microbiome, novel biologics, and small molecules like Janus kinase inhibitors (e.g., tofacitinib) introduce competitive challenges. These alternatives aim for improved efficacy, safety, or convenience, potentially impacting UCERIS's market share.

Financial Trajectory

1. Sales Revenue Trends

Since its launch, UCERIS has experienced a steady revenue increase, attaining approximately USD 250 million globally in 2022 [4]. North America remains its primary revenue generator, accounting for over 70% of sales, driven by a large ulcerative colitis patient base and high prescribing rates.

2. Growth Drivers

• Expanding Clinical Indications: Efforts to include maintenance therapy indications or extend into other inflammatory bowel diseases could unlock new revenue streams.
• Market Penetration Strategies: Increasing adoption in emerging markets, aided by strategic partnerships and localized pricing, can accelerate sales growth.
• Formulation and Delivery Innovations: Developing controlled-release formulations or combination therapies could enhance efficacy, foster increased prescribing, and command premium pricing.

3. Pricing and Reimbursement Dynamics

UCERIS's premium positioning is justified by its targeted delivery and safety advantages, but pricing pressures from generics and biosimilars, especially in mature markets, may constrain margins. Strategic negotiations and value-based reimbursement models will influence future profitability.

4. Competitive Risks and Opportunities

The influx of novel therapies necessitates agile market strategies. Investment in R&D to improve formulations or explore new indications could secure competitive advantage, extending UCERIS's market lifespan.

Future Outlook

Forecasts project UCERIS's global sales to reach approximately USD 400 million by 2028, contingent upon expanding indications, optimizing pricing strategies, and enhancing market penetration [5]. Maintaining regulatory patience and addressing clinician hesitancy will be pivotal. Innovative collaborations, including combination therapies with biologics, could further increase its share in the IBD treatment paradigm.

Regulatory and Market Challenges

Balancing rapid commercialization with ongoing clinical validation remains critical. Additionally, government healthcare policies favoring biosimilars could impact branded product revenues, requiring proactive adaptation.

Key Drivers for Sustained Growth

• Expansion into maintenance and other indication areas.
• Geographic expansion into emerging markets.
• Strategic collaborations with healthcare providers and payers.
• Investment in formulation improvements and delivery systems.
• Vigilant compliance with evolving regulatory standards.

---

Key Takeaways

• UCERIS's targeted delivery and safety profile position it as an effective treatment for mild to moderate ulcerative colitis, filling a crucial niche within the IBD market.
• The drug’s revenue trajectory indicates steady growth, with potential acceleration through indication expansion and market penetration.
• Competitive pressures from biologics, biosimilars, and emerging therapies necessitate strategic innovation and positioning.
• Reimbursement landscape and global regulatory trends will critically influence future profitability.
• Stakeholders should focus on clinical validation, innovative formulation, and strategic geographic expansion to sustain and enhance UCERIS’s market value.

---

FAQs

1. What distinguishes UCERIS from traditional corticosteroids?
UCERIS employs a targeted delivery system that minimizes systemic absorption, reducing side effects and allowing for safer long-term use in ulcerative colitis management [2].

2. How does UCERIS's market share compare to biologics?
While biologics dominate severe ulcerative colitis treatment, UCERIS leads in the mild-to-moderate segment. Its niche positioning offers a safer, cost-effective alternative to systemic corticosteroids [3].

3. What are the primary growth opportunities for UCERIS?
Expanding indications to include maintenance therapy, entering emerging markets, and developing innovative formulations are key growth drivers.

4. How are reimbursement policies affecting UCERIS sales?
Reimbursement favoring oral, safety-profile driven therapies supports UCERIS, though pricing pressures from generic competitors challenge profit margins.

5. What competitive threats does UCERIS face?
Biologics, biosimilars, and novel small molecules targeting IBD continue to evolve, potentially encroaching on UCERIS’s market segment and necessitating ongoing strategic adaptation.

---

Sources

[1] Markets and Markets, "Inflammatory Bowel Disease Therapeutics Market," 2022.
[2] FDA Label, UCERIS (budesonide), 2014.
[3] PubMed Clinical Trial Data, ULTRA 2 Study, 2015.
[4] IQVIA Sales Data, 2022.
[5] MarketResearch.com, "IBD Drugs Market Forecast," 2023.