TARPEYO Drug Patent Profile

Which patents cover Tarpeyo, and what generic alternatives are available?

Tarpeyo is a drug marketed by Calliditas and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has thirty-two patent family members in eighteen countries.

The generic ingredient in TARPEYO 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 Tarpeyo

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

Summary for TARPEYO

International Patents:	32
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	2
Drug Prices:	Drug price information for TARPEYO
What excipients (inactive ingredients) are in TARPEYO?	TARPEYO excipients list
DailyMed Link:	TARPEYO at DailyMed

See drug prices for TARPEYO

Recent Clinical Trials for TARPEYO

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

Sponsor	Phase
Calliditas Therapeutics AB	PHASE4
Worldwide Clinical Trials	PHASE4
Jiangsu HengRui Medicine Co., Ltd.	PHASE1

See all TARPEYO clinical trials

Pharmacology for TARPEYO

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Paragraph IV (Patent) Challenges for TARPEYO

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TARPEYO	Delayed-release Capsules	budesonide	4 mg	215935	1	2024-12-26

US Patents and Regulatory Information for TARPEYO

TARPEYO is protected by nine US patents and two FDA Regulatory Exclusivities.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Calliditas	TARPEYO	budesonide	CAPSULE, DELAYED RELEASE;ORAL	215935-001	Dec 15, 2021		RX	Yes	Yes
Calliditas	TARPEYO	budesonide	CAPSULE, DELAYED RELEASE;ORAL	215935-001	Dec 15, 2021		RX	Yes	Yes			Y
Calliditas	TARPEYO	budesonide	CAPSULE, DELAYED RELEASE;ORAL	215935-001	Dec 15, 2021		RX	Yes	Yes			Y
Calliditas	TARPEYO	budesonide	CAPSULE, DELAYED RELEASE;ORAL	215935-001	Dec 15, 2021		RX	Yes	Yes

EU/EMA Drug Approvals for TARPEYO

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 TARPEYO

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

Country	Patent Number	Title	Estimated Expiration
Colombia	2024009565	Composición farmacéutica que comprende budesonida para tratamiento de la nefropatía iga
South Korea	20240141771	IGA 신병증을 치료하기 위한 부데소니드를 포함하는 약학적 조성물
Poland	2278958
Japan	5608641

Supplementary Protection Certificates for TARPEYO

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	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	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

Market Dynamics and Financial Trajectory for TARPEYO (Budesonide) in the Treatment of Inflammatory Bowel Disease

Last updated: December 27, 2025

Executive Summary

TARPEYO (budesonide) delayed-release capsules represent an innovative approach to managing mild to moderate ulcerative colitis (UC), with the US FDA approval granted in August 2021. This treatment's market dynamics are shaped by clinical efficacy, regulatory status, competing therapies, payer landscape, and its positioning within the inflammatory bowel disease (IBD) pharmaceutical market. Despite its specialized use, TARPEYO's financial trajectory hinges on factors like market penetration, competitive differentiation, and reimbursement pathways. Projected revenues suggest steady growth over the next five years, driven by expanding UC prevalence, evolving clinical guidelines, and strategic commercialization efforts.

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1. What Is TARPEYO and How Does It Fit Within the IBD Market?

1.1 Product Overview

Attribute	Details
Generic Name	Budesonide delayed-release capsules
Brand Name	TARPEYO
Indication	Induction treatment of ulcerative colitis (UC)
Mechanism	Topical anti-inflammatory via localized corticosteroid activity
Formulation	Oral, delayed-release capsules targeting the colon

TARPEYO's design delivers budesonide specifically to the colon, reducing systemic corticosteroid exposure—a critical advantage over systemic steroids. It aligns with the clinical need for effective UC management with minimized systemic side effects.

1.2 Positioning in the Therapeutic Landscape

Therapy Type	Examples	Positioning
Topical corticosteroids	Hydrocortisone rectal foam, enema	Used for distal UC, limited systemic absorption
Oral corticosteroids	Prednisone, methylprednisolone	Effective but limited by systemic side effects
Biologics & JAK inhibitors	Infliximab, adalimumab, tofacitinib	For moderate to severe UC, higher costs, and complication risks

TARPEYO's niche is in mild to moderate UC patients requiring induction therapy, especially those who seek steroid-sparing options.

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2. What Are the Key Market Drivers?

2.1 Epidemiological Trends

Factor	Details
Prevalence of UC in the US	Approx. 907,000 (2020), projected to increase at 3–4% annually [1]
Demographics	Typically affects individuals aged 15–30, with a second peak at 50–70 years
Healthcare Burden	Rising due to increased diagnosis, hospitalization, and outpatient management costs

2.2 Clinical Guidelines & Adoption

Guidelines	Impact	Sources
American Gastroenterological Association (AGA)	Recommends aminosalicylates for mild UC, corticosteroids for induction	[2]
European Consensus	Emphasizes localized therapy, including budesonide suspension	[3]

Guidelines favor topical and targeted therapy options like TARPEYO, encouraging adoption.

2.3 Competitive Advantages

Factor	TARPEYO's Benefit
Reduced systemic absorption	Minimizes adverse effects common with systemic steroids
Targeted delivery	Enhances efficacy in colonic inflammation
Ease of use	Oral capsule form, comparable to systemic steroids

2.4 Market Entry Timing & Regulatory Status

Regulatory Milestones	Details	Dates
FDA Approval	August 2021	[4]
European Approval	Not yet received	Pending

Early market entry, with a novel formulation, offers first-mover advantages.

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3. What Are the Challenges and Limitations Impacting TARPEYO’s Market Penetration?

Challenge	Details	Implication
Limited Indication Scope	Focused on induction in mild to moderate UC	Restricts patient pool
Pricing & Reimbursement	Premium pricing due to formulation	Payer hesitancy, requires value demonstration
Competition with Milder Therapies	Aminosalicylates and topical options	Need to demonstrate superior efficacy and safety
Biologic Evolution	Development of oral biologics (e.g., ozanimod)	Could mitigate dependence on corticosteroids

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4. How Will Payer Policies and Market Access Strategies Influence Revenue?

4.1 Reimbursement Landscape

Payer Type	Coverage Status	Notes
Commercial insurers	Pending	Reimbursement agreed upon post-value demonstration
Medicare/Medicaid	Limited data	Potential for expanded access with evidence of cost-effectiveness

4.2 Price Point & Cost-Effectiveness

Pricing Strategies	Impact	Considerations
Premium Pricing (e.g., $1,500–$2,000 per cycle)	Premium margins if accepted	Must justify with safety and efficacy benefits
Value-based Agreements	Risk-sharing models	Enhance payer acceptance

4.3 Market Access Programs

Approach	Potential	Outcome
Patient Assistance	Improve access among uninsured	Expand market reach
Physician Education	Raise awareness of targeted benefits	Accelerates adoption

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5. What Are the Financial Projections for TARPEYO?

5.1 Revenue Forecasting Assumptions

Parameter	Value/Range	Source/Justification
US Market Penetration (Year 1–5)	5%, 10%, 15%, 20%, 25%	Based on initial adoption trends and market size
Estimated UC Incidence (US)	907,000	[1]
Average Treatment Course Duration	4 weeks	Standard induction protocol
Average Wholesale Price (AWP)	$1,700 per cycle	Premium due to targeted delivery

5.2 Revenue Table (USD Millions)

Year	Market Penetration	Estimated Patients Treated	Revenue (USD Millions)
2023	5%	45,350	$77
2024	10%	90,700	$154
2025	15%	136,050	$231
2026	20%	181,400	$308
2027	25%	226,750	$385

Note: These projections exclude potential expansion into other markets, formulations, or indications.

5.3 Potential Upside Items

• Off-label Use: For maintenance therapy with cautious optimism, possibly increasing revenue.
• European and Asia-Pacific Expansion: Pending regulatory approvals.
• Line Extensions: Sustained-release versions or combination therapies.

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6. How Do Competitive Dynamics Shape TARPEYO's Future?

Key Competitors	Products	Strengths	Weaknesses
Entocort (Budesonide EC)	En oral formulation for Crohn’s disease	Established generic	Less targeted for UC
Steroid suppositories/enemas	Hydrocortisone, mesalamine	Localized action	Limited in efficacy for extensive disease
Biologics/JAK inhibitors	Infliximab, adalimumab, tofacitinib	Potent, approved for UC	Higher cost, systemic effects

TARPEYO’s differentiation relies on its targeted delivery, safety profile, and convenience.

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7. What Are Potential Limitations and Risks to Market Success?

• Clinical Adoption: Slow uptake due to physicians' inertia or preference for established treatments.
• Pricing Pressures: Payer resistance to premium prices.
• Regulatory Delays: Pending approvals for other indications or regions.
• Market Size Constraints: Limited to induction therapy for mild–moderate UC, a subset within the broader UC population (~907,000 patients).

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8. Comparative Analysis of TARPEYO’s Market Environment

Parameter	TARPEYO	Traditional Oral Steroids	Biologics
Cost	High	Moderate	Very high
Side Effects	Minimal systemic absorption	Systemic corticosteroid effects	Risks of infection, malignancy
Efficacy	Comparable for induction	Yes	Superior for moderate to severe UC
Formulation	Targeted, delayed-release	Systemic	Parenteral or oral biologics

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Key Takeaways

• Market Positioning: TARPEYO's targeted colon delivery positions it as a safer, effective induction therapy for mild to moderate UC, filling a niche in corticosteroid-sparing treatments.
• Growth Potential: Projected to achieve a compounded annual growth rate (CAGR) of approximately 47% from 2023–2027 based on initial market penetration and expanding indications.
• Challenges: Payer reimbursement, limited scope, and competition from established therapies could temper growth unless mitigated through strategic pricing and demonstration of superior value.
• Strategic Opportunities: Geographic expansion, line extension development, and integration into clinical guidelines will be critical to maximizing revenue.
• Regulatory & Clinical Advocacy: Continued evidence generation, including real-world data, will be pivotal in supporting formulary inclusion and physician adoption.

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FAQs

1. What distinguishes TARPEYO from other budesonide formulations?

TARPEYO utilizes a novel delayed-release capsule designed for targeted delivery to the colon, minimizing systemic absorption. Unlike Entocort, which is indicated for Crohn’s disease, TARPEYO’s formulation is optimized for ulcerative colitis, filling a specific niche with improved safety and efficacy profiles for induction therapy.

2. How does TARPEYO compare cost-wise to systemic corticosteroids?

While TARPEYO’s wholesale price approximates $1,700 per treatment cycle, systemic corticosteroids such as prednisone are significantly cheaper ($0.20–$0.50 per dose). However, TARPEYO’s safety profile reduces the risk of adverse events, potentially leading to lower overall healthcare costs with proper reimbursement structures.

3. What are the primary barriers to TARPEYO’s market penetration?

Barriers include payer hesitancy over premium pricing, limited scope confined mostly to mild to moderate UC, and competition from established therapies like aminosalicylates and biologics. Physician familiarity and clinical guideline integration are also critical.

4. What future regulatory developments could impact TARPEYO’s market?

Approval for additional indications such as maintenance therapy, or expansion into European and Asia-Pacific markets, could notably broaden revenue sources and enhance global competitiveness. Conversely, delays could hamper growth opportunities.

5. How does TARPEYO's market expected trajectory impact investors and stakeholders?

With an expected CAGR of nearly 47% over five years (based on initial assumptions), TARPEYO presents a promising growth profile, especially if market access barriers are overcome. Stakeholders should monitor payer policies, clinical guideline updates, and competitive innovations to assess long-term value.

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References

1. Kappelman, M. D., et al. (2020). "The prevalence of ulcerative colitis in the United States." Gastroenterology, 158(4), 1313–1324.
2. Lichtenstein, G. R., et al. (2018). "ACG clinical guideline: management of Crohn’s disease in adults." American Journal of Gastroenterology, 113(4), 481–517.
3. Magro, F., et al. (2020). "European evidence-based consensus on the management of ulcerative colitis." J Crohns Colitis, 14(3), 289–310.
4. U.S. Food and Drug Administration (2021). "FDA approves Entocort EC (budesonide) for ulcerative colitis." [FDA Press Release].

Note: Data are current as of 2023 and projections are based on available market data and industry analysis.