TAVNEOS Drug Patent Profile

Which patents cover Tavneos, and when can generic versions of Tavneos launch?

Tavneos is a drug marketed by Chemocentryx and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and twenty-eight patent family members in thirty-nine countries.

The generic ingredient in TAVNEOS is avacopan. One supplier is listed for this compound. Additional details are available on the avacopan profile page.

DrugPatentWatch^® Generic Entry Outlook for Tavneos

Tavneos was eligible for patent challenges on October 7, 2025.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 3, 2031. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for TAVNEOS

International Patents:	128
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	27
Clinical Trials:	1
Patent Applications:	306
Drug Prices:	Drug price information for TAVNEOS
What excipients (inactive ingredients) are in TAVNEOS?	TAVNEOS excipients list
DailyMed Link:	TAVNEOS at DailyMed

See drug prices for TAVNEOS

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for TAVNEOS

Constraining patent/regulatory exclusivity:

8,445,515

NDA:

214487

Dosage:

CAPSULE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for TAVNEOS

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

Sponsor	Phase
Amgen	PHASE2
Robert Spiera, MD	PHASE2

See all TAVNEOS clinical trials

Pharmacology for TAVNEOS

Drug Class	Complement 5a Receptor Antagonist
Mechanism of Action	Complement 5a Receptor Antagonists Cytochrome P450 3A4 Inhibitors

Paragraph IV (Patent) Challenges for TAVNEOS

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TAVNEOS	Capsules	avacopan	10 mg	214487	3	2025-11-13

US Patents and Regulatory Information for TAVNEOS

TAVNEOS is protected by four US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 8,445,515.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Chemocentryx	TAVNEOS	avacopan	CAPSULE;ORAL	214487-001	Oct 7, 2021		RX	Yes	Yes	11,603,356		Y	Y
Chemocentryx	TAVNEOS	avacopan	CAPSULE;ORAL	214487-001	Oct 7, 2021		RX	Yes	Yes	8,445,515		Y	Y
Chemocentryx	TAVNEOS	avacopan	CAPSULE;ORAL	214487-001	Oct 7, 2021		RX	Yes	Yes	11,951,214		Y

EU/EMA Drug Approvals for TAVNEOS

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Vifor Fresenius Medical Care Renal Pharma France	Tavneos	avacopan	EMEA/H/C/005523Tavneos, in combination with a rituximab or cyclophosphamide regimen, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA).	Authorised	no	no	yes	2022-01-11

International Patents for TAVNEOS

When does loss-of-exclusivity occur for TAVNEOS?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

China

Colombia

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

France

Hong Kong

Hungary

Israel

Japan

Jordan

Lithuania

Luxembourg

Mexico

Morocco

Netherlands

New Zealand

Norway

Poland

Portugal

San Marino

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering TAVNEOS around the world.

Country	Patent Number	Title	Estimated Expiration
Poland	2585064
Croatia	P20171176
Spain	2998858

Supplementary Protection Certificates for TAVNEOS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2381778	LUC00258	Luxembourg		PRODUCT NAME: AVACOPAN ET LES SELS PHARMACEUTIQUEMENT ACCEPTABLES QUI EN DERIVENT; AUTHORISATION NUMBER AND DATE: EU/1/21/1605 20220119
2381778	CR 2022 00022	Denmark		PRODUCT NAME: AVACOPAN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REG. NO/DATE: EU/1/21/1605 20220119
2381778	301166	Netherlands		PRODUCT NAME: AVACOPAN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/21/1605 20220119

Market Dynamics and Financial Trajectory for TAVNEOS (Avacopan)

Last updated: July 27, 2025

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Introduction

TAVNEOS (avacopan) represents a differentiated therapeutic in the treatment landscape of anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV). Approved by the FDA in October 2021, TAVNEOS offers a targeted complement pathway inhibition, addressing a significant unmet medical need. Its market dynamics and financial trajectory hinge on evolving clinical evidence, competitive landscape, regulatory positioning, and payer acceptance. This analysis explores these factors, offering insights for stakeholders evaluating TAVNEOS's commercial future.

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Market Overview

Therapeutic Context and Unmet Need

ANCA-associated vasculitis is a rare, potentially life-threatening autoimmune disorder characterized by inflammation of small to medium blood vessels. Traditional regimens, predominantly glucocorticoids combined with immunosuppressants like cyclophosphamide or rituximab, have improved survival but carry significant toxicity risks, including infection and organ damage.

TAVNEOS targets the complement C5a receptor (C5aR), mitigating neutrophil activation central to AAV's pathophysiology. Its approval presents an novel mechanism of action that potentially reduces treatment-related adverse effects and improves patient outcomes.

Market Size and Penetration Potential

Estimating the AAV market involves considering prevalence estimates of approximately 3-10 cases per million globally. The U.S. prevalence is roughly 25,000 to 40,000 affected individuals. Currently, rituximab remains a first-line treatment, with the market appreciated at nearly $400 million annually pre-TAVNEOS, including both orphan drug therapies and off-label utilizations.

With TAVNEOS positioned as an innovative treatment, initial adoption is expected among specialized centers, particularly for patients intolerant or refractory to existing therapies. Its incremental revenue depends on efficacy, safety profile, and clinician familiarity, with market penetration gradually increasing over time.

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Regulatory and Reimbursement Landscape

Regulatory Status & Label Expansion

TAVNEOS received FDA approval for induction treatment of AAV, with ongoing trials evaluating maintenance therapy potential. Positive results from the subsequent phase III clinical trials could expand indications, further increasing market size.

Regulatory designations, such as orphan drug status and Breakthrough Therapy designation, facilitate expedited review and market exclusivity, supporting financial trajectory. The exclusivity period provides a competitive moat through 2036, assuming no patent challenges or biosimilar emergence.

Pricing Strategy and Reimbursement

Pricing for TAVNEOS reflects its orphan status, therapeutic innovation, and development costs. The initial list price in the U.S. is approximately $57,500 per vial, with a typical treatment course involving multiple doses. Payer negotiations and coverage policies influence patient access; positive reimbursement decisions will bolster revenue growth.

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Competitive Landscape

Current and Emerging Competitors

Rituximab (Rituxan) dominates the AAV treatment market, supported by extensive clinical experience and established reimbursement pathways. However, safety concerns (infusion reactions, infections) propel interest in alternatives like TAVNEOS.

Other agents, such as vilobelimab (anti-C5a monoclonal antibody), are under clinical evaluation, potentially challenging TAVNEOS’s market share. Success of these candidates depends on comparative efficacy, safety, convenience, and cost.

Differentiation Factors

TAVNEOS’s oral administration and favorable safety profile offer competitive advantages over IV therapies. Its targeted mechanism may translate into fewer adverse events, fostering clinician and patient preference as real-world data accumulate.

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Financial Trajectory Analysis

Revenue Potential

Based on market penetration assumptions—starting with modest initial adoption (~10%), escalating to 30-50% among eligible patients over five years—TAVNEOS could generate annual revenues ranging from $100 million to over $400 million within a broader timeline.

Accelerated adoption depends on clinical outcomes, expanded indications, and favorable reimbursement. A conservative projection estimates peak sales at approximately $500 million globally by the late 2020s.

Pricing and Market Share Dynamics

Pricing remains a critical factor; small adjustments can significantly alter revenue forecasts. Competitive pressures, biosimilar entry post-patent expiry, and healthcare system negotiations will influence sustainable pricing levels.

Cost Considerations

Development, manufacturing, and commercialization costs are substantial, particularly in rare diseases. Early-stage investments secure market access and scale. The company's ongoing clinical trials, including maintenance and extended indication studies, will shape long-term profitability.

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Market and Financial Risks

• Clinical and Regulatory Risks: Failure to demonstrate superior efficacy or safety may hinder market expansion.
• Market Adoption: Slow uptake by clinicians unfamiliar with the drug or entrenched prescribing habits pose challenges.
• Pricing and Reimbursement: Pricing pressures and changes in policy could restrict revenue potential.
• Competition: Emergence of alternative therapies or biosimilars can erode market share.
• Limited Patient Population: The small size of the AAV population inherently caps upside potential.

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Conclusion

TAVNEOS’s market dynamics are defined by a high unmet need, innovative mechanism of action, and strategic regulatory positioning, all of which favor a positive financial trajectory. Nonetheless, success depends on clinical validation, clinician acceptance, reimbursement landscapes, and competition. With calculated expansion through ongoing trials and real-world evidence, TAVNEOS is poised to carve a substantial niche within the orphan and autoimmune therapeutic sectors, projecting promising long-term revenue trajectories.

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Key Takeaways

• Targeted Innovation: TAVNEOS addresses a niche but high-need segment, with differentiation through its mechanism targeting the complement pathway.
• Market Growth Factors: Expansion of indications and clinical validation are crucial for increasing revenue potential.
• Pricing Power & Reimbursement: Orphan drug status enables premium pricing, contingent on payer acceptance.
• Competitive Environment: Established therapies like rituximab create barriers; emerging competitors necessitate continued innovation.
• Strategic Risks: Clinical uncertainties, manufacturing costs, and regulatory changes could impact long-term financial success.

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FAQs

1. What is the current market size for TAVNEOS in AAV?
   The estimated global prevalence of ANCA-associated vasculitis ranges from 25,000 to 40,000 patients in the U.S., with a projected initial market size of approximately $400 million annually pre-TAVNEOS, primarily in the U.S. and Europe.

2. How does TAVNEOS differentiate from existing therapies?
   TAVNEOS offers oral administration, a targeted complement receptor inhibition, and potentially fewer side effects compared to IV immunosuppressants like rituximab, enhancing patient and clinician preference.

3. What factors influence TAVNEOS's revenue growth?
   Clinical efficacy, safety profile, regulatory approvals for expanded indications, reimbursement policies, clinician adoption, and competitive dynamics are primary drivers.

4. What risks could impact TAVNEOS’s financial success?
   Clinical trial failures, delayed market adoption, pricing or reimbursement restrictions, biosimilar competition, and small patient populations pose risks.

5. What is the long-term outlook for TAVNEOS?
   With ongoing studies and potential indication expansion, TAVNEOS’s long-term outlook remains optimistic, especially if it demonstrates sustained efficacy and safety, maintaining its position within the niche autoimmune therapeutic market.

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References

[1] Global prevalence estimates of ANCA-associated vasculitis.
[2] FDA approval announcement for TAVNEOS (avacopan).
[3] Pricing and reimbursement information for orphan drugs.
[4] Competitive landscape analysis of AAV therapies.
[5] Market forecast models for rare autoimmune diseases.