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 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			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	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

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
Austria	251449
Australia	5680100	Controlled release and taste masking oral pharmaceutical compositions
Canada	2377301	COMPOSITIONS PHARMACEUTIQUES ADMINISTRABLES PAR VOIE ORALE ALIBERATION CONTROLEE ET GOUT MASQUE (CONTROLLED RELEASE AND TASTE MASKING ORAL PHARMACEUTICAL COMPOSITIONS)
China	1173695

Supplementary Protection Certificates for UCERIS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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
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

Last updated: July 24, 2026

Uceris (budesonide) Market Dynamics and Financial Trajectory (2010–Present): Competition, Pricing Pressure, and Exclusivity/Patent Risk

Executive summary: Uceris (budesonide, oral extended-release) is a niche, label-driven chronic inflammatory bowel disease asset in the US. Its market trajectory has been shaped by (1) long-tail steroid safety-positioning, (2) payer and formulary churn typical of non-biologic IBD therapies, (3) generic and branded-competitive erosion dynamics in the budesonide oral segment, and (4) ongoing substitution pressure from topical and alternative steroid and immunomodulator classes. Commercial performance is sensitive to US exclusivity and Orange Book status of product-specific patents and to the timing of generic entries or “authorized” supply that reprice the class.

No complete, decision-grade financial and exclusivity dataset is provided in the prompt (e.g., IQVIA/Assumptions sales, FDA labeling dates, Orange Book patent-by-patent status, litigation outcomes, or generic approval/launch dates). Without those inputs, a complete and accurate market-financial trajectory with quantified revenue and date-stamped entry events cannot be produced.

What is Uceris (budesonide) and how does it fit the US IBD treatment landscape?

Featured snippet answer: Uceris is an oral budesonide formulation used for induction of remission in active mild-to-moderate ulcerative colitis (UC) and is positioned as a locally acting corticosteroid with lower systemic exposure than conventional oral steroids.

Indication scope and competitive substitutes

Key substitutes across the UC treatment funnel include:

• Other systemic corticosteroids (prednisone/prednisolone class) for induction
• Budesonide rectal/topical products (for distal disease, when applicable)
• 5-ASA agents for maintenance or mild disease
• Immunomodulators and biologics (adalimumab, infliximab, vedolizumab, ustekinumab) for steroid-sparing strategies
• Small-molecule agents (e.g., JAK inhibitors, depending on guideline evolution and payer preference)

Market implication: Uceris typically competes on “short-course steroid induction” and tolerability rather than durable disease modification.

How have payer dynamics and formulary management affected Uceris market share?

Featured snippet answer: Uceris faces formulary management pressure common to branded oral steroids and non-biologic IBD assets, especially as generic versions of budesonide products or therapeutic substitutes become available.

Common US payer forces

• Step-therapy and prior authorization around corticosteroid induction
• “Fail-first” requirements for non-branded options (5-ASA) depending on disease severity
• Brand-to-generic substitution once FDA approval and market entry reduce net price
• Preferred drug lists for UC induction where clinical guidelines shift treatment order

Market implication: Net price erosion can precede or exceed volume erosion after generic entry, rebates tightening, and restricted formulary placement.

When does Uceris lose exclusivity and how do generic entry risks change the outlook?

Featured snippet answer: Uceris’ exclusivity and generic entry risk depends on the Orange Book status of the drug product and method patents tied to the specific budesonide extended-release oral formulation.

What determines generic entry timing

Generic entry timing in the budesonide oral extended-release space is governed by:

• Patent expiration of the listed drug-product and use-related patents
• Any applicable statutory exclusivities (if triggered) linked to the NDA holder’s exclusivity grants
• Successful Paragraph IV challenges and settlement-triggered design-arounds (if any)

Market implication: Any Orange Book patent early-expiration, consent judgment, or settlement “skinny label” work can pull launch dates forward and accelerate price compression.

What is the Orange Book status of Uceris and which patents matter most for launch barriers?

Featured snippet answer: Launch barriers are driven by the Orange Book “listed” patents for the specific Uceris NDA and by the claims most likely asserted against generic filers.

Patent estate elements typically most sensitive to litigation

For oral extended-release budesonide products, the most commercially material patents often involve:

• Drug substance formulation or composition-of-matter claims
• Drug product formulation and manufacturing/process claims (release control, excipient systems)
• Method-of-use claims tied to UC induction/remission language
• Device or dosage form claims unique to the extended-release platform

Market implication: Patent claims that survive motions or show high infringement likelihood most strongly influence settlement likelihood and generic launch dates.

How does Uceris compare with competing budesonide and IBD steroid options on access and pricing?

Featured snippet answer: Uceris competes primarily against other steroid induction options and budesonide delivery routes; its access and pricing depend on net reimbursement versus generic budesonide and alternative induction agents.

Budesonide route and payer preference

• Oral extended-release (Uceris) is positioned for UC induction when systemic steroid alternatives are required
• Rectal/topical budesonide options can be payer-preferred for distal disease segments, reducing oral utilization for subsets of patients

Non-budesonide substitutes

Payer behavior often shifts utilization to:

• 5-ASA (in mild cases or as a preferred baseline)
• Immunomodulators/biologics when patients need steroid-sparing long-term control, especially with guideline updates and patient-specific risk profiles

What patent litigation or Paragraph IV challenges affect Uceris generic entry?

Featured snippet answer: Paragraph IV challenges and related litigation can materially alter launch timing and net pricing through stay/settlement outcomes.

Litigation pathways that move market dynamics

• FDA approval timing after patent certifications
• 30-month stay triggers following first Paragraph IV notice
• Settlement terms that cap launch dates or allow “at-risk” launches earlier than expected
• Design-around outcomes that shift generic feasibility to a different claim scope

Market implication: Where litigation drives delayed entry, branded revenue can remain resilient; where entry is accelerated, price compression tends to be rapid in non-exclusivity-driven niche segments.

What is Uceris’ financial trajectory by revenue drivers: volume, net price, and channel mix?

Featured snippet answer: For niche specialty brands like Uceris, revenue is usually dominated by net price adjustments tied to formulary access and generic/biosimilar-adjacent competition risk; volume tends to track IBD incidence trends and guideline-driven steroid induction patterns.

Revenue framework

• Net price: Most sensitive to generic introduction or competing branded rebate intensity
• Volume: Sensitive to patient flows to alternatives (topical budesonide, steroid-sparing biologics, small molecules)
• Mix: Higher utilization in mild-to-moderate UC induction windows can soften as prescribers shift to earlier advanced therapies

Market implication: Without quantified sales time series, a decision-grade financial trajectory cannot be reconstructed here.

Which companies commercialize Uceris and how do biosimilar and generic supply dynamics influence net pricing?

Featured snippet answer: Generic and branded supply in IBD steroid segments can drive rapid net price declines once substitution is authorized and payer policies allow switching.

Channel mechanics

• Wholesaler buy patterns and contract pricing
• PBM rebates contingent on formulary placement
• Channel inventory impacts around patent cliffs

Market implication: Even modest volume changes can produce outsized revenue effects when net price compresses.

How strong is the patent estate for Uceris and what is its impact on investor and licensing value?

Featured snippet answer: The market value of Uceris hinges on whether drug-product and method-of-use patents remain enforceable past key generic “entry trigger” dates.

Investor-focused indicators

A strong estate typically shows:

• Multiple listed patents across drug product and method-of-use
• Litigation history consistent with enforcement
• Unexpired exclusivities plus staggered expirations that delay full generic substitution

Market implication: A dense, staggered patent estate supports longer branded retention; a narrow estate with earlier clean expiration increases generic entry risk and reduces forecast visibility.

What generic launch scenarios exist for Uceris and how would each affect brand revenue?

Featured snippet answer: Launch scenarios range from delayed generic entry due to enforceable patents to earlier entry via settled or adjudicated patent scope changes, with corresponding net price impact.

Scenario mapping

• Delayed launch: Brand net price remains higher; volume may slowly erode to substitutes
• At-cliff entry: Rapid rebate and switch behavior; steep net price drop
• Design-around/skinny label: Partial substitution may slow the steepness of price erosion if patient access remains constrained

Market implication: Post-entry revenue often depends more on formulary conversion speed than on wholesale demand.

What manufacturing and regulatory factors can block or accelerate Uceris generic competition?

Featured snippet answer: Manufacturing reproducibility for extended-release profiles and regulatory characterization of dissolution/release behavior can influence approval feasibility and product interchangeability.

Typical constraints

• Release profile comparability for extended-release oral products
• Stability and bioequivalence for key excipient systems
• Scale-up and process validation for generic applicants

Market implication: Manufacturing and formulation barriers can delay or limit generic competitive pressure even after formal approval timelines.

Key Takeaways

• Uceris is a locally acting oral corticosteroid positioned for UC induction; its market is sensitive to payer policy, guideline-driven steroid use, and competition from alternative budesonide routes and steroid-sparing therapies.
• Generic and patent-status developments are the main accelerants of net price compression.
• A quantified financial trajectory with date-stamped generic entry and exclusivity milestones cannot be produced from the information provided in the prompt.

FAQs

1. How do PBM prior authorization policies typically affect branded oral budesonide utilization like Uceris?
2. What are the most common differentiation points in extended-release budesonide formulations that impact generic bioequivalence?
3. How do corticosteroid guideline shifts for ulcerative colitis change the patient funnel for Uceris?
4. What Orange Book patent categories most often drive Paragraph IV litigation for branded oral extended-release steroids?
5. How does generic entry timing usually translate to net price erosion speed in niche IBD brands?

References

1. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (Uceris, budesonide) [Database]. U.S. Food and Drug Administration.
2. FDA labels and prescribing information for Uceris (budesonide) extended-release tablets. U.S. Food and Drug Administration.
3. Clinical guideline publications for ulcerative colitis induction and steroid use.

DrugChatter Q&A for UCERIS

Why is uceris so expensive?