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-six 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 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:	36
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	2
Drug Prices:	Drug price information for TARPEYO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases 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	11,896,719
Calliditas	TARPEYO	budesonide	CAPSULE, DELAYED RELEASE;ORAL	215935-001	Dec 15, 2021		RX	Yes	Yes	8,491,932		Y
Calliditas	TARPEYO	budesonide	CAPSULE, DELAYED RELEASE;ORAL	215935-001	Dec 15, 2021		RX	Yes	Yes	12,311,057		Y
Calliditas	TARPEYO	budesonide	CAPSULE, DELAYED RELEASE;ORAL	215935-001	Dec 15, 2021		RX	Yes	Yes	12,171,882
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
Calliditas	TARPEYO	budesonide	CAPSULE, DELAYED RELEASE;ORAL	215935-001	Dec 15, 2021		RX	Yes	Yes	12,171,883		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
Australia	2023210461
Canada	3249575
Chile	2024002201
China	118591376
China	120053463
China	120754111
China	120754112

Supplementary Protection Certificates for TARPEYO

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
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	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
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

TARPEYO (budesonide) market dynamics and financial trajectory: pricing, volume drivers, payer coverage, and exclusivity-driven competitive risk

Last updated: July 22, 2026

Executive summary: TARPEYO (budesonide) is positioned as an oral, targeted anti-inflammatory therapy for IgA nephropathy in adults at risk of disease progression, launched in 2022 under a limited US indication and with a premium-branded pricing structure. Market dynamics are dominated by (1) payer access for a high-cost steroid product, (2) prescriber adoption constrained by guideline alignment and diagnostic workflows, and (3) exclusivity duration and patent estate strength affecting generic and biosimilar-like competitive threats. Financial trajectory has followed the pattern of a newly introduced specialty drug: early uptake concentrated in specialist-driven accounts with subsequent expansion tied to formulary negotiations, sequencing of therapy in IgAN treatment pathways, and label-specific reimbursement certainty. Key downside risk comes from any erosion to formulary status, channel inventory shifts, and future generic entry timing under Orange Book listed patents.

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What is TARPEYO’s market position in IgA nephropathy, and why does it drive premium pricing?

What payer and provider segments drive TARPEYO demand

TARPEYO is used in adults with IgA nephropathy at risk of disease progression. Commercial pull is driven primarily by:

• Nephrologist prescribing: IgAN management is specialist-led, so adoption tracks nephrology workflow capacity and familiarity with budesonide-based regimens.
• Diagnostic gating and risk stratification: patients must be identified as “at risk of disease progression,” limiting addressable volume relative to broader CKD populations.
• Treatment sequencing: TARPEYO competes for “where budesonide fits” among supportive care, RAAS blockade, immunosuppression in more advanced phenotypes, and later-line biologic or immunomodulatory approaches (where applicable).

Why the product is priced as a specialty renal therapy

TARPEYO’s pricing is set to support a specialty launch model where:

• Cost-per-course is materially higher than low-cost generic steroids because therapy is chronic/ongoing in many real-world patterns.
• Reimbursement uncertainty risk is mitigated through coverage evidence and payer contract terms rather than broad OTC-like adoption.
• Steroid safety profile management creates structured prescribing requirements that reinforce a specialty distribution model.

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How fast has TARPEYO ramped financially since launch, and what KPIs show that trajectory?

Financial trajectory indicators investors track

Financial trajectory for a new specialty nephrology asset typically tracks:

• Net sales vs. wholesaler inventory (channel fill and pull-through)
• Average selling price (ASP) and rebate rate (payer negotiation depth)
• Prescription trends by specialty and geography (whether uptake broadens beyond early adopter centers)
• Persistence and refill behavior (steroid course adherence and discontinuation)

What to expect from an IgA nephropathy specialty product ramp

Typical ramp mechanics:

• Initial concentration in large nephrology practices and academic referral centers.
• Gradual expansion after early payer coverage decisions and site-level formularies.
• Sustained growth dependency on outcomes-based confidence and continued payer authorization stability, not on rapid conversion from primary care.

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What exclusivity timelines matter for TARPEYO’s financial outlook?

When does TARPEYO lose exclusivity in the US?

TARPEYO’s US exclusivity is a function of:

• Regulatory exclusivity (new drug and indication-related exclusivities)
• Patent term for drug substance, formulations, and method-of-use
• Potential exclusivity extensions (if any) tied to pediatric, supplemental applications, or formulation changes

How exclusivity affects near-term revenue risk

• Until key patent/regulatory milestones pass, the generic threat window is mostly theoretical, so financial performance is less sensitive to discounting.
• As milestones approach, payers begin cost-positioning, prescribers test alternative regimens, and manufacturers increase contract terms to lock in coverage.

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What patents protect TARPEYO, and how strong is the overall patent estate?

How patent categories affect competitive entry risk

A full protection stack usually spans:

1. Drug substance and active ingredient claims
2. Formulation and release/processing claims
3. Method-of-use claims aligned to IgA nephropathy dosing and patient selection criteria
4. Manufacturing/process claims for intermediates or capsule/tablet architecture

Why method-of-use claims can extend market protection

Even if generic product manufacture is cleared for a drug substance, method-of-use claims can:

• delay Paragraph IV incentives when the challenger cannot “carve out” a non-infringing use,
• constrain settlement structure (design-around may be difficult if patient population and dosing are covered),
• support pay-for-delay leverage in settlement negotiations.

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Are there Paragraph IV ANDA challenges or biosimilar-like threats to TARPEYO?

What counts as a credible generic threat

For a steroid product like budesonide with specific IgA nephropathy positioning:

• The challenger needs to overcome Orange Book listed patents at filing time.
• Even if the ANDA product is approved, launch timing depends on whether litigation leads to carve-outs or agreed launch dates.
• Settlement agreements can shift the effective launch timeline far beyond theoretical patent expiry.

Settlement-driven launch scenarios

Common outcomes:

• “No-early” settlements that delay first generic launch.
• Design-around approvals that allow earlier entry but still face payer slowdowns and formulary management frictions.
• Staggered introductions where different strengths or dosage forms launch later.

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What is the Orange Book status of TARPEYO, and how does it map to generic launch timing?

How to interpret Orange Book listings for launch risk

Orange Book listings drive generic timing via:

• listed patent number coverage of the NDA
• listed patent expiry and any regulatory exclusivity overlay
• active litigation posture and enforceable claim scope

Launch timing model for payers

Payer contracting generally uses:

• expected generic date (based on patent expiry + litigation settlement patterns)
• probability-weighted risk of earlier-than-expected entry
• switching cost assumptions (clinical inertia and authorization processes)

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What formulations of TARPEYO are protected, and what does that mean for generic substitutes?

Dosage form and strength can materially change generic risk

Protection can be strength-specific or formulation-specific. Generic challengers may face:

• bioavailability and release-profile constraints if formulation claims are asserted,
• incompatibilities with protected manufacturing processes,
• patient selection constraints if method-of-use claims dominate infringement analyses.

What payers will negotiate if generics are imminent

As generic dates approach, formularies often move from:

• open coverage to preferred brand vs. therapeutic alternatives,
• tighter prior authorization requirements,
• step therapy constraints that manage steroid safety risk.

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How does TARPEYO compare with other IgA nephropathy therapies and steroids economically?

Competitive set: within-class steroid and across-mechanism regimens

TARPEYO competes on:

• route (oral targeted budesonide)
• treatment setting (specialist-managed chronic disease)
• payer acceptance for renal outcomes pathways

Economic comparison drivers

• Net price after rebates and payer-specific discounts
• Patient persistence (steroid course continuity)
• Hospitalization and complication avoidance (if outcomes translate into downstream cost offsets)

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What litigation and regulatory events can change TARPEYO revenue?

US FDA regulatory posture

Revenue risk tied to FDA events includes:

• label expansions or restrictions,
• safety communications affecting prescribing behavior,
• REMS-like governance (if applicable) or changes in postmarketing requirements.

Patent litigation that tends to move the needle

The highest revenue impact usually comes from:

• court decisions narrowing or strengthening method-of-use claim scope,
• settlements establishing hard launch dates,
• injunction outcomes that prevent generic shipment.

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How do payer coverage dynamics shape TARPEYO’s net sales versus list price?

What typically happens to ASP and rebate levels in specialty launches

As TARPEYO expands:

• initial coverage may lean more permissive for early uptake,
• net price erosion often follows as payers renegotiate discounts to manage budget impact,
• rebate rates rise as formularies shift from non-preferred to preferred or preferred-tier placement.

Authorization constraints can cap utilization

Prior authorization requirements can:

• reduce immediate scripts,
• delay starts until documentation is complete,
• increase discontinuations for non-responders if coverage is contingent on response metrics.

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What generic entry risks exist for TARPEYO, and what launch scenario fits the revenue outlook best?

Three entry scenarios payers model

1. Delayed entry: patents and litigation extend the practical absence of generics, allowing continued brand premium pricing.
2. At-risk entry: a generic launches upon final approvals but pricing erosion may be slower if clinical switching is cautious.
3. Settlement-based mid-window entry: lower priced generics appear before full patent expiry, pressuring net revenue earlier than model-based “patent date” assumptions.

Revenue sensitivity to each scenario

• Delayed entry favors sustained margin and fewer contract resets.
• At-risk and settlement-based entry increase budget pressure, pushing payers to increase utilization controls and shift to lowest net cost options.

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Which companies could compete with TARPEYO commercially if generics launch?

How competitor landscape forms in nephrology specialty launches

If generic TARPEYO enters, competitors usually include:

• established generic manufacturers with ANDA portfolios in steroids,
• specialty generics distributors for renal indications,
• alternative branded therapies if mechanistic competition accelerates.

Where competition is felt first

• high-volume nephrology centers,
• payer accounts already using step therapy and prior authorization levers,
• formularies with explicit “preferred steroid” status categories.

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Key Takeaways

• TARPEYO’s market dynamics are driven by nephrology-led adoption in IgA nephropathy, payer authorization behavior, and persistence patterns that determine pull-through from prescriptions to ongoing use.
• Financial trajectory follows a specialty launch curve where net sales depend more on net price (rebates/discounts) and coverage stability than on list price.
• The largest revenue lever remains exclusivity and the strength of Orange Book-listed patents spanning formulation and method-of-use, which govern when generics can launch without infringement exposure or litigation-driven delay.
• Generic entry risk is best modeled through litigation and settlement-driven scenarios rather than simple patent expiry dates, because payer switching and discounting react quickly once practical supply uncertainty ends.

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FAQs

1. How do prior authorization requirements affect TARPEYO patient starts and refill persistence?
2. What is the most important TARPEYO patent category for delaying generic entry: formulation, method-of-use, or drug substance?
3. How should payers model TARPEYO net price erosion under a settlement-based generic launch?
4. What label-specific factors for IgA nephropathy influence TARPEYO’s addressable market growth?
5. How do FDA safety communications for steroids typically impact specialty nephrology prescribing patterns?

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References

1. (No sources provided in the prompt.)

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