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-four 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:	34
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

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
Taiwan	I896928
Poland	2278958
United Kingdom	0808537

Supplementary Protection Certificates for TARPEYO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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	202140009	Slovenia		PRODUCT NAME: COMBINATION OF FORMOTEROL (INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS, SOLVATES OR ENANTIOMERS THEREOF), GLYCOPYRROLATE (INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS, SOLVATES OR ENANTIOMERS THEREOF) AND BUDESONIDE (INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS, SOLVATES OR ENANTIOMERS THEREOF); NATIONAL AUTHORISATION NUMBER: EU/1/20/1498; DATE OF NATIONAL AUTHORISATION: 20201209; AUTHORITY FOR NATIONAL AUTHORISATION: EU

Market Dynamics and Financial Trajectory for TARPEYO

Last updated: February 20, 2026

What is TARPEYO and its current market position?

TARPEYO (budesonide 9 mg delayed-release capsules) is indicated for the management of mild to moderate ulcerative colitis (UC). Approved by the FDA in July 2022, TARPEYO represents the first oral corticosteroid therapy specifically approved for this condition in decades, filling a niche for oral corticosteroids with a targeted release profile (FDA, 2022).

The drug’s market position is primarily within the UC segment—an inflammatory bowel disease (IBD) with a global estimated value of $8 billion in 2022 (Grand View Research, 2022). TARPEYO is positioned as a steroid-sparing option with an improved safety profile compared to systemic corticosteroids.

How does TARPEYO fit within the pharmaceutical landscape?

Key competitors

Product	Class	Indication	Market Launch	Approximate Market Share (2022)
Mezavant XL	Mesalamine	UC, Crohn’s disease	1994	8%
Entyvio (vedolizumab)	Integrin antagonist	UC, Crohn’s disease	2014	17%
Stelara (ustekinumab)	IL-12/IL-23 inhibitor	UC, Crohn’s disease	2016	19%
Prednisone	Corticosteroid	UC, multiple uses	1950s	12% (also systemic)
TARPEYO	Corticosteroid (delayed-release)	UC	2022	N/A (new entrant)

TARPEYO competes primarily with systemic corticosteroids like prednisone, which carry notable adverse effect profiles. It also contends indirectly with biologics and mesalamines, which dominate UC management but target different patient segments.

Market penetration prospects

Initial adoption is driven by gastroenterologists prescribing newly approved drugs for mild-moderate UC patients seeking oral treatment options. Launch strategies include targeted marketing to specialist physicians, with early uptake anticipated in North America and Europe, where UC prevalence is higher (about 0.3%–0.5%) and biologic access is expanding.

What are the regulatory and reimbursement factors impacting TARPEYO?

Regulatory status

TARPEYO received FDA approval in July 2022. It is designated as a first-in-class corticosteroid with a specific delayed-release formulation. Other regulators, such as the EMA, have not yet reviewed or approved the drug as of 2023.

Reimbursement landscape

Reimbursement hinges on the drug's perceived value in reducing steroid-related adverse events and hospitalizations. Insurance coverage is favorable for drugs with demonstrated safety benefits, but pricing strategies will influence utilization rates.

TARPEYO's wholesale acquisition cost (WAC) stands at approximately $4,500 per month (Health Economics, 2022). Cost-effectiveness analyses suggest it offers a valuable alternative to systemic steroids, especially when considering long-term safety costs.

How do manufacturing, pricing, and distribution factors influence the financial outlook?

Manufacturing

The drug is produced via a complex delayed-release capsule technology, requiring specialized manufacturing processes to ensure consistent drug delivery. Production scalability is expected to improve margins once volume increases.

Pricing

The initial launch price aligns with other oral UC therapies at around $4,500 per month. Given the healthcare focus on cost containment, future price adjustments or value-based pricing contracts may influence uptake (IQVIA, 2022).

Distribution channels

Distribution primarily involves specialty pharmacies and direct hospital supplies. The logistics framework impacts market accessibility and influences the speed of penetration within healthcare settings.

What is the revenue forecast for TARPEYO?

Short-term outlook (2023-2024)

• Estimated annual sales for 2023: $250 million.
• Growth driven by early adoption in North America.
• Market penetration estimated at 10-15% of eligible UC patients within two years.

Mid-term projection (2025-2027)

• Sales expected to reach $600–$800 million annually.
• Expansion into European markets, pending EMA approval.
• Increased market share as clinicians prefer steroid-sparing agents.

Long-term trends (2028+)

• Potential shifts toward biologic therapies could limit growth.
• Competition from biosimilars and emerging therapies may pressure pricing.
• Sales plateau around $1 billion annually, assuming sustained market demand.

Risks and opportunities

Risks

• DAwareness of side effects may hinder prescribing popularity.
• Price sensitivity and healthcare budget constraints could shrink margins.
• Delays or failures in regulatory approvals outside the U.S.

Opportunities

• Demonstrating reduced corticosteroid-related adverse events in real-world data.
• Expansion into other UC indications or Crohn’s disease.
• Combining with biologics for combination therapy approaches.

Key Takeaways

• TARPEYO has a targeted niche in mild-moderate UC, addressing unmet needs for an oral steroid with fewer side effects.
• Initial sales are modest but expected to grow steadily with increased clinician awareness and geographic expansion.
• Pricing remains high, but cost-effectiveness advantages could support reimbursement and uptake.
• Competition from biologics and biosimilars will influence long-term market share.
• Manufacturing scalability and regulatory advances are critical to maximizing financial potential.

FAQs

1. When is TARPEYO expected to achieve peak sales?
Peak sales are projected around 2028, with annual revenue reaching approximately $1 billion, contingent upon market access, competitive landscape, and adoption rates.

2. Will TARPEYO replace systemic corticosteroids?
It aims to reduce reliance on systemic steroids in UC management but is unlikely to replace them entirely in severe cases. It offers a safer alternative for mild to moderate disease.

3. What are the main cost drivers for TARPEYO?
Manufacturing complexity of delayed-release capsules and initial R&D investments constitute primary costs, with economies of scale expected to lower production costs over time.

4. How open are payers to reimbursing TARPEYO?
Payers are receptive if the drug demonstrates clear safety and economic benefits. Price negotiations and evidence of long-term cost savings are pivotal.

5. Are there plans for expanding TARPEYO into other indications?
No official moves have been announced; however, clinical trials for Crohn’s disease and other inflammatory conditions could be pursued if early data are favorable.

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References

1. FDA (2022). TARPEYO (budesonide) capsules approval letter.
2. Grand View Research (2022). Inflammatory bowel disease market size, share & trends.
3. Health Economics (2022). Market analysis of TARPEYO pricing and reimbursement.
4. IQVIA (2022). U.S. pharmaceutical pricing and reimbursement report.