UCERIS Drug Patent Profile

When do Uceris patents expire, and what generic alternatives are available?

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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for UCERIS

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

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
China	1355693	Controlled release and taste masking oral pharmaceutical compositions
Germany	60005819

Supplementary Protection Certificates for UCERIS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	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	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	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
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

UCERIS (budesonide) investment scenario and patent/IP fundamentals analysis

Last updated: July 6, 2026

Uceris (budesonide) is an established, off-patent brand in the US for ulcerative colitis and Crohn’s disease indications using controlled-release oral budesonide. The US opportunity in a public-market investment frame is driven less by near-term exclusivity and more by (i) line-of-business durability via formulary status and (ii) competitive intensity from generic oral budesonide controlled-release products, with remaining value anchored in brand management, payer contracting, and manufacturing quality rather than new patent-driven price protection.

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What is Uceris and how does it fit in ulcerative colitis and Crohn’s treatment?

Uceris is a budesonide corticosteroid delivered as an oral controlled-release formulation. In the US, Uceris is positioned for inflammatory bowel disease (IBD) where topical steroid activity in the gut is sought with reduced systemic exposure relative to conventional steroids.

Which indications does Uceris cover

• Ulcerative colitis (UC) for induction of remission (commonly described as mild to moderate active UC, dosing by tapering schedules).
• Crohn’s disease (historically tied to controlled-release budesonide use in ileocecal region and mild to moderate active disease; US labeling details depend on current FDA-approved language).

How Uceris is used clinically

• Oral controlled-release budesonide is typically used for induction of remission and can be part of stepwise therapy before escalation to immunomodulators or biologics.
• Real-world prescribing often depends on steroid sparing strategies and rapid access to next-line therapies.

Commercial implication

Uceris competes in the UC steroid-induction bucket that includes:

• Systemic corticosteroids (less targeted exposure)
• Other oral and rectal anti-inflammatories (5-ASA and targeted agents)
• Escalation pathways to biologics, JAK inhibitors, and integrin antagonists As therapies shift toward steroid-sparing and disease-modifying agents, maintenance of budesonide share depends on payer economics and clinical positioning rather than therapeutic leadership.

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What is the Orange Book status of UCERIS (budesonide controlled-release) in the US?

Featured snippet answer: Uceris is marketed in the US as an oral controlled-release budesonide product with Orange Book listings that have historically supported brand exclusivity at launch, but the core composition and early-use protection has largely fallen behind generic entry timing for most practical investment horizons.

What Orange Book listings typically cover for Uceris

Orange Book listings for oral budesonide controlled-release products usually include:

• Drug substance and composition patents (if any still listed)
• Drug product formulation or controlled-release mechanism patents (if still within term)
• Method-of-use patents tied to dosing regimens and indications
• Patents expiring per statutory and filed claim sets

How to interpret Orange Book for investing

For an investor, the key is not the count of Orange Book patents but:

• Whether any listed patents remain in force
• Whether they are tied to the specific dosage forms marketed (for example, extended release tablets)
• Whether any formulation patents could still block “non-infringing” generic design-arounds

Practical barrier level

With an established brand and a mature steroid category, generic competition risk is front-loaded. The question for Uceris is less “is it patent protected” and more “is it still strategically protectable through remaining product-specific claims and market access?”

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When does Uceris lose exclusivity and when can generics launch?

Featured snippet answer: Uceris exclusivity is dominated by patent expiration and any remaining regulatory exclusivity that sits on top of Orange Book protection. In practice, the market is already in the generic-penetration phase for oral budesonide controlled-release, with remaining brand value driven by contracting and supply execution, not exclusivity.

Exclusivity components investors should model

1. Patent term expiration (including potential pediatric exclusivity where applicable)
2. Any regulatory exclusivity tied to new formulations or new indications
3. Paragraph IV litigation windows (if any patents were still in-force during relevant generic filing periods)

Generic launch trigger mechanics

• If a generic filer files an ANDA with Paragraph IV certifications against Orange Book patents, it creates a 30-month stay if applicable.
• Launch timing then depends on settlement outcomes, court rulings, and any residual patent term.

Investment modeling implication

In a staged cashflow model, Uceris tends to behave like a “late-life brand” where:

• Price erosion is already realized
• Incremental downside comes from continued share loss, discounting pressure, and fewer payer tolerances for high-cost brands
• Upside comes from contracting strength, stable inventory supply, and limited substitution in patient populations with prior authorization rules

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How many patents cover Uceris and what types of patents are in the estate?

Featured snippet answer: The Uceris estate is typically a mix of composition, formulation/control-release, and method-of-use claims, with the investment-relevant subset being the last-to-expire product-specific patents and any method-of-use claims still asserted by the brand.

Patent categories investors screen

• Composition of matter
• Controlled-release formulation (matrix, coating, dissolution profile)
• Manufacturing process or scale-up constraints
• Method-of-use (UC dosing regimen, induction endpoints)
• Combination patents (if any) with other IBD agents, though Uceris is primarily single-agent

What matters for generic “design-around”

Generic risk is reduced if:

• Release profile is defined by specific polymer/crosslinking system and dissolution criteria that are hard to replicate. Generic risk accelerates if:
• Release profile claims are broad or not tied to uniquely characterized parameters.

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What generic entry risks exist for UCERIS (budesonide controlled-release tablets)?

Featured snippet answer: Generic entry risk is structurally high for established oral corticosteroid products, with the remaining uncertainty largely tied to product-specific formulation claims and whether launch-driving Orange Book patents remain enforceable.

Risk drivers

• Number and timing of Orange Book patents still active
• Litigation history and settlements that may shape launch dates
• Bioequivalence and manufacturing capability constraints for controlled-release profiles
• Payer and pharmacy benefit manager (PBM) substitution policies that amplify generic uptake

Where investors should look

• ANDA approvals and tentative approvals for controlled-release budesonide products
• Any ongoing patent infringement cases that would re-time launch
• Net price trends and reimbursement rates in major markets

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What patent litigation affects Uceris and how do settlements change launch timing?

Featured snippet answer: Uceris has participated in the standard US patent litigation ecosystem for late-life brands: Paragraph IV challenges against Orange Book patents with potential 30-month stays and settlements. The investing takeaway is the speed at which generic products convert from “threat” to “net revenue pressure.”

Litigation mechanics that matter

• Filing date of ANDA (defines timing of Paragraph IV certifications)
• Patent list at issue (defines infringement scope)
• Claim construction and final judgment outcomes (define whether additional generics can launch)
• Settlement agreements that may include:
  • “Agreed-upon” launch dates
  • Non-infringement carve-outs
  • Licensing terms (less common in mature steroid categories unless still-active formulation patents exist)

How to incorporate into underwriting

Model two scenarios:

1. “Early conversion” where generic products launch without meaningful delay.
2. “Delayed conversion” where settlements or injunctions extend brand pricing protection.

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What FDA status applies to Uceris and what regulatory pathway governs generics?

Featured snippet answer: Uceris is an FDA-approved oral budesonide controlled-release product. Generic entrants use the ANDA pathway, relying on bioequivalence and linking to FDA-approved reference product labeling where allowable.

Regulatory pathway for generics

• ANDA: requires bioequivalence to reference product and appropriate certifications to Orange Book patents.
• Labeling: generic can use the RLD labeling unless carve-outs are required by patent carve-out agreements and court findings.

Clinical and regulatory friction points

• Controlled-release products can face extra scrutiny in ensuring dissolution and release profile similarity.
• If label carve-outs are required, that can reduce interchangeability and delay payer substitution.

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How does Uceris compare with other oral corticosteroids and IBD steroid options?

Featured snippet answer: Uceris competes with systemic steroids and other targeted-release steroid products. Its differentiation historically sits on reduced systemic exposure and a gut-localized delivery profile.

Competitive comparison frame

Key differentiators investors should map into commercial models:

• Net price versus generic alternatives
• Formulary placement (preferred vs non-preferred)
• PA requirements and step edits
• Switching behavior after first prescription
• Patient persistence once controlled-release is established

Substitution likelihood

As generic-controlled budesonide becomes available, switching likelihood rises where:

• PBMs enforce generic substitution
• Patients have mild to moderate disease where physician choice is flexible
• Payers reduce coverage for brand steroids after initial step therapies

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Which companies manufacture and market UCERIS, and who are the generic competitors?

Featured snippet answer: Uceris is historically a brand product with generic controlled-release budesonide competitors entering through ANDAs once Orange Book protection and exclusivity windows close. Company-level assessment should be based on the most current FDA labeling and ANDA approval lists tied to the controlled-release oral budesonide product.

How to structure competitive intelligence

• Track ANDA approvals by dosage strength and label language
• Monitor launch timing by market (nationwide vs region)
• Map PBM contract versions, rebate structures, and formulary tier changes

Commercial consequence

Generic competitors compress gross-to-net margins for the reference brand even if total steroid volumes remain stable, because utilization shifts from higher-cost brand to lower-cost generics.

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What formulation and delivery patents could still matter for Uceris (controlled-release tech)?

Featured snippet answer: Formulation and controlled-release delivery patents typically have the highest residual relevance for generic competition if their claims are specific to polymer systems, coatings, or dissolution criteria that are difficult to replicate.

Key formulation levers

• Matrix or coating composition controlling pH-dependent release
• Dissolution profile windows and specification limits
• Manufacturing process steps affecting release characteristics

Investor relevance

Even if composition-of-matter patents expire, formulation patents can still block “near-equivalent” generics that copy the same release mechanics without sufficiently altering polymer/coating or dissolution metrics. This is where remaining Orange Book listings often matter.

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Is biosimilar risk relevant for Uceris?

Featured snippet answer: No. Uceris is a small-molecule corticosteroid (budesonide), not a biologic. Biosimilar frameworks do not apply.

Implication

Competition risk is driven by ANDAs and controlled-release generic product performance, not biosimilar interchangeability or immunogenicity.

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What is the investment scenario for Uceris: upside, downside, and value drivers?

Featured snippet answer: The investment case for Uceris is primarily a “brand residual value” story in a genericized oral steroid segment, with underwriting sensitivity focused on gross-to-net compression, formulary durability, and any remaining product-specific IP that can slow generic share capture.

Downside factors

• Ongoing generic substitution and pricing pressure
• Further tightening of payer coverage for brand steroids
• Loss of channel inventory momentum leading to lower volume
• Any court rulings or FDA events that accelerate generic competition

Upside factors

• Strong contracting and persistence in patient cohorts who remain on the brand
• Limited interchangeability due to label or formulation differences
• Any remaining enforceable formulation patents that keep some generics from launching at full strength or with full labeling

Value drivers by financial line

• Revenue: dependent on volume and net price declines
• Gross margin: compressed by generics unless brand is protected by formulary positioning
• Operating leverage: maintained through cost discipline and supply stabilization
• Litigation and settlement: can create temporary price support if launch re-timed

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Key Takeaways

• Uceris is a mature budesonide controlled-release brand with high structural generic pressure typical of late-life oral corticosteroids.
• Investment underwriting should center on Orange Book status and any remaining formulation- or method-of-use-driven enforceability, because exclusivity-led upside is limited in late life.
• The practical risk is accelerated gross-to-net compression driven by ANDA entrants and formulary substitution.
• Biosimilar risk is not relevant; competition is ANDA-based.
• Value is best modeled as residual brand durability and contracting strength rather than new patent-led growth.

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FAQs

1. What ORANGE BOOK patents for controlled-release budesonide most influence generic launch timing?
2. How do Paragraph IV ANDA certifications typically affect Uceris pricing and launch calendars?
3. What differences in controlled-release dissolution profiles can block or enable generic budesonide?
4. How do payer step edits and prior authorization rules change brand versus generic substitution for oral steroids?
5. What label carve-outs after patent settlements mean for interchangeability and pharmacy switching?

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References (APA)

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. US Food and Drug Administration. (Current database accessed via FDA Orange Book).
2. FDA. Drug Approval and Databases: ANDA. US Food and Drug Administration. (Regulatory pathway overview).