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-one 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:	3
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	10,660,858		Y
Salix	UCERIS	budesonide	TABLET, EXTENDED RELEASE;ORAL	203634-001	Jan 14, 2013	AB	RX	Yes	Yes	9,192,581		Y
Salix	UCERIS	budesonide	TABLET, EXTENDED RELEASE;ORAL	203634-001	Jan 14, 2013	AB	RX	Yes	Yes	8,895,064		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	8,293,273
Salix	UCERIS	budesonide	TABLET, EXTENDED RELEASE;ORAL	203634-001	Jan 14, 2013	10,105,374
Salix	UCERIS	budesonide	AEROSOL, FOAM;RECTAL	205613-001	Oct 7, 2014	5,914,122
Salix	UCERIS	budesonide	TABLET, EXTENDED RELEASE;ORAL	203634-001	Jan 14, 2013	9,532,954

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
Turkey	200200562
Japan	H10511364
Denmark	1183014
European Patent Office	1183014	COMPOSITIONS PHARMACEUTIQUES ADMINISTRABLES PAR VOIE ORALE A LIBERATION CONTROLEE ET GOUT MASQUE (CONTROLLED RELEASE AND TASTE MASKING ORAL PHARMACEUTICAL COMPOSITIONS)

Supplementary Protection Certificates for UCERIS

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

Market Dynamics and Financial Trajectory for UCERIS (Budesonide)

Last updated: February 19, 2026

What is UCERIS and How Does It Fit Into the Market?

UCERIS (budesonide) is an oral corticosteroid approved by the FDA for the treatment of active, mild to moderate ulcerative colitis (UC). Developed by Flexion Therapeutics, the drug is formulated with controlled-release technology. UCERIS competes primarily with other UC treatments, including mesalamine formulations, immunomodulators, and biologics.

Market Size and Growth

The ulcerative colitis market is driven by an increasing prevalence of inflammatory bowel diseases. Global UC treatment market is projected to grow at a compound annual growth rate (CAGR) of approximately 5.5% from 2022 to 2028, driven by rising UC incidence, especially in North America and Europe (Grand View Research, 2022).

In 2022, the global inflammatory bowel disease (IBD) market was valued at $7.3 billion, with UC accounting for approximately 65%. The UC segment is expected to reach $8.9 billion by 2028.

UCERIS Market Share and Position

In 2022, UCERIS held an estimated 3-5% market share in the UC therapeutic landscape, primarily competed by mesalamine products. Its positioning hinges on its targeted delivery system, offering an alternative for patients refractory to or intolerant of topical therapies.

Pharmacoeconomic and Clinical Positioning

UCERIS advantages include a favorable safety profile, reduced systemic absorption, and convenience of oral dosing. It is prescribed mainly for mild to moderate UC, often as a first-line or adjunct therapy. Its efficacy is comparable to topical corticosteroids, with fewer systemic side effects.

Competitive Landscape

• Top competitors include mesalamine formulations (e.g., Lialda, Rowasa).
• Biologics like infliximab, adalimumab, are reserved for more severe UC cases.
• Other corticosteroids such as prednisone are used systemically but with higher side effect profiles.

Revenue Trends and Financial Performance

In 2018, UCERIS generated approximately $69 million in sales (Flexion Therapeutics 10-K). Sales peaked around 2019 at approximately $80 million, then declined to roughly $50 million in 2021 as competition intensified.

The decline reflects the advent of biosimilars, increased utilization of biologics, and market saturation. Pricing strategies and formulary access influence revenue trajectories.

Pricing and Reimbursement Policies

UCERIS’s list price in 2022 was around $2,300 per four-week supply. Insurance coverage and payer restrictions influence actual patient access and prescription volumes.

Reimbursement remains stable due to FDA approval exclusivity, but payers increasingly favor biosimilars and generics over branded corticosteroids, exerting downward pressure on pricing.

Regulatory Trends and Approvals

• UCERIS received FDA approval in 2013 for UC.
• Patent protections extend until at least 2030; however, generic competition is limited due to formulation-specific patents.
• Regulatory focus on safety and efficacy continues to shape the competitive environment.

Future Outlook

Potential growth drivers:

• Expanded indications, such as Crohn's disease or pouchitis.
• Longer-term studies demonstrating safety and efficacy.
• Strategic partnerships to expand geographic reach.

Risks:

• Increased biosimilar and generic competition.
• Market saturation.
• Shifts towards biologic therapies for moderate-to-severe UC.

Financial Forecasts

• Sales are projected to decline gradually through 2025, reaching approximately $40 million annually, based on current competitive trends.
• Market share in UC treatments may stabilize at around 2-3%, as new formulations and alternative therapies enter the market.

Key Takeaways

• UCERIS’s market is constrained by competition from both traditional therapies and biologics.
• Revenue peaked in 2019, then declined with the advent of biosimilars and biologic therapies.
• Pricing policies and reimbursement pressures influence market penetration.
• Growth avenues include expanded indications and expanded geographic sales.
• Long-term success depends on maintaining patent protection and developing adjunctive therapeutics.

FAQs

1. How does UCERIS compare with other UC treatments in terms of efficacy?
UCERIS’s efficacy aligns with topical corticosteroids but is generally less potent than biologics for severe cases. It provides targeted relief for mild to moderate UC.

2. What are the main barriers to market growth for UCERIS?
Market saturation, biosimilar competition, a shift toward biologics for severe UC, and reimbursement constraints limit growth.

3. Are biosimilars impacting UCERIS's sales?
Not directly, as biosimilars target biologic therapies, not corticosteroids like UCERIS. However, overall UC treatment landscape shifts influence UCERIS’s market share.

4. What strategies could enhance UCERIS's market position?
Expanding indications, securing partnerships for global distribution, and demonstrating long-term safety can support growth.

5. How significant is patent protection for UCERIS’s future?
Patents extend into at least 2030, offering exclusivity. Patent expiry risks will increase pressure from generics unless novel formulations are developed.

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References

[1] Grand View Research. (2022). Inflammatory Bowel Disease Market Size, Share & Trends Analysis Report.
[2] Flexion Therapeutics. (2018). 10-K Annual Report.
[3] U.S. Food and Drug Administration. (2013). UCERIS approval documentation.