Avacopan - Generic Drug Details

What are the generic sources for avacopan and what is the scope of freedom to operate?

Avacopan is the generic ingredient in one branded drug marketed by Chemocentryx and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

One supplier is listed for this compound.

Summary for avacopan

International Patents:	128
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	27
Clinical Trials:	11
Patent Applications:	482
What excipients (inactive ingredients) are in avacopan?	avacopan excipients list
DailyMed Link:	avacopan at DailyMed

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

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 avacopan

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

Sponsor	Phase
Robert Spiera, MD	PHASE2
Amgen	PHASE2
Ottawa Hospital Research Institute	PHASE3

See all avacopan clinical trials

Pharmacology for avacopan

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

Anatomical Therapeutic Chemical (ATC) Classes for avacopan

L04AA	Selective immunosuppressants
L04A	IMMUNOSUPPRESSANTS
L04	IMMUNOSUPPRESSANTS
L	Antineoplastic and immunomodulating agents

L04AJ	Complement inhibitors
L04A	IMMUNOSUPPRESSANTS
L04	IMMUNOSUPPRESSANTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for avacopan

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			Y	Y
Chemocentryx	TAVNEOS	avacopan	CAPSULE;ORAL	214487-001	Oct 7, 2021		RX	Yes	Yes			Y	Y
Chemocentryx	TAVNEOS	avacopan	CAPSULE;ORAL	214487-001	Oct 7, 2021		RX	Yes	Yes

EU/EMA Drug Approvals for avacopan

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 avacopan

Country	Patent Number	Title	Estimated Expiration
Serbia	64250	FORMULACIJE KAPSULA (CAPSULE FORMULATIONS)
Poland	4233850
Jordan	3346

Supplementary Protection Certificates for avacopan

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2381778	2290502-0	Sweden		PRODUCT NAME: AVACOPAN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REG. NO/DATE: EU/1/21/1605 20220119
2381778	SPC/GB22/014	United Kingdom		PRODUCT NAME: AVACOPAN (AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF); REGISTERED: UK EU/1/21/1605(FOR NI) 20220119; UK FURTHER MA ON IPSUM 20220119
2381778	C02381778/01	Switzerland		FORMER OWNER: CHEMOCENTRYX, INC., US

Market Dynamics and Financial Trajectory for Avacopan

Last updated: July 27, 2025

Introduction

Avacopan, marketed under the brand name Tavneos by ChemDiv and later marketed by Advemme or other licensing partners, is a novel oral complement C5a receptor inhibitor developed by Vertex Pharmaceuticals. It gained regulatory approval for the treatment of anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV), a rare but severe autoimmune disorder. This article examines the evolving market landscape, key drivers, challenges, and the financial trajectory shaping avacopan’s commercial prospects.

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Therapeutic Profile and Market Need

Avacopan’s Mechanism of Action:
Avacopan selectively inhibits the C5a receptor (C5aR), dampening the inflammatory cascade initiated in autoimmune vasculitis. Traditional treatment options, like corticosteroids combined with immunosuppressants, pose risks of adverse effects, including increased infection risk and steroid-related complications. The unmet need for effective steroid-sparing therapies positions avacopan as an innovative alternative.

Market Need:
ANCA-associated vasculitis affects approximately 3 to 10 individuals per million globally (per recent epidemiological studies [1]), underscoring its classification as a ultra-rare disease. Historically, managed largely through immunosuppressive regimens, the desire for treatments with better safety profiles and improved patient outcomes drives commercial interest.

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Market Dynamics

Regulatory and Clinical Milestones

FDA Approval and EMA Authorization:
In 2019, the U.S. FDA approved avacopan for AAV based on positive clinical trial data, specifically the ADVOCATE study, which demonstrated non-inferiority to high-dose steroids and improved renal outcomes [2]. The European Medicines Agency (EMA) granted marketing authorization in 2021. These approvals underpin the drug’s market entry and expansion potential.

Clinical Adoption and Guidelines:
While early adoption is promising, real-world use remains limited to specialized centers. Updated treatment guidelines and physician education will be critical. The drug’s steroid-sparing benefits may influence long-term adoption, especially among patients at high risk of corticosteroid adverse effects.

Market Penetration Challenges

Rare Disease Market Limitations:
Due to the ultra-rare nature of AAV, the total addressable market (TAM) remains small—estimated at less than $1 billion globally. Market penetration depends on awareness, clinician familiarity, and access to healthcare resources.

Pricing & Reimbursement:
In the U.S., phased reimbursement and premium pricing pose both opportunities and challenges. Pricing, typically in the range of several tens of thousands per patient annually, hinges on demonstrating clear clinical benefit and cost offsets related to fewer hospitalizations and reduced steroid-associated complications [3].

Competitive Landscape:
Currently, no direct C5aR inhibitors are approved for AAV. However, other biologics targeting B cells (e.g., rituximab) and systemic immunosuppressants are established. Avacopan’s differentiation lies in its oral route and steroid-sparing profile, which could confer a competitive edge.

Market Drivers

• Clinical Efficacy and Safety: Demonstrated ability to reduce corticosteroid dependence and improve renal outcomes.
• Regulatory Support: Accelerated approvals or priority review could expedite market entry.
• Patient Quality of Life: Improved safety profile encourages adherence and willingness among clinicians to prescribe.
• Healthcare Cost Savings: Reduction in steroid-related adverse events and hospitalizations can make a compelling case for payers.

Market Barriers

• Limited Patient Pool: Market growth constrained by disease rarity.
• Physician Awareness: Lack of familiarity may delay adoption.
• Long-term Data: Need for extended safety and durability data to foster physician confidence and insurer reimbursement.

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Financial Trajectory

Revenue Potential and Growth Projections

Initial Sales Estimates:
Initial sales are projected modestly, fueled by early adopters in specialized centers. According to industry analysts, early revenues might total in the range of $50-100 million within the first few years post-launch, assuming successful market access and uptake [4].

Long-term Growth:
Market expansion depends on:

• Broader clinician awareness.
• Expansion into other indications like bullous pemphigoid, where complement pathways are implicated.
• Geographic expansion into Europe, Asia, and other regions.

Based on modeling, the long-term worldwide sales for avacopan could reach approximately $300-500 million annually if it captures a significant share of the niche AAV treatment market.

Pricing Strategies and Reimbursement

• Premium Pricing: Given the rarity and clinical benefits, premium pricing models are plausible.
• Reimbursement Trends: Payers will evaluate cost-effectiveness based on clinical data demonstrating reduced hospitalization rates, steroid-related adverse events, and improved renal outcomes.

Investment and Commercial Strategy

Pharmaceutical companies must allocate significant investment toward:

• Raising awareness among physicians.
• Building manufacturing capacity to meet potential demand.
• Conducting post-marketing studies to establish long-term safety and efficacy.

Pipeline and Future Opportunities

Exploration into additional indications, such as other autoimmune inflammatory conditions involving complement dysregulation, could diversify revenue streams. The potential approval pathways for broader indications could significantly influence financial trajectory.

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Market Outlook and Future Trends

• Growing Unmet Need: As awareness of steroid-sparing therapies gains momentum, avacopan’s market share could expand.
• Emergence of Competitors: Advancements in complement pathway inhibitors and biologics may alter competitive dynamics.
• Regulatory Evolution: Positive post-marketing evidence may lead to label expansions and better reimbursement coverage.
• Patient-Centric Approaches: Preference for oral medications over infusions enhances market appeal.

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Key Takeaways

• Avacopan is positioned to revolutionize AAV treatment by offering a steroid-sparing, targeted complement inhibitor.
• The ultra-rare nature of AAV limits market size but also reduces competition, presenting a niche opportunity.
• Real-world adoption depends heavily on physician education, reimbursement frameworks, and further long-term clinical data.
• The financial outlook is cautiously optimistic, with potential revenues reaching hundreds of millions annually if broader indications and geographic markets are successfully penetrated.
• Strategic investments in evidence generation, market access, and pipeline expansion are vital for sustained growth.

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FAQs

1. What are the primary advantages of avacopan in treating ANCA-associated vasculitis?
Avacopan offers selective complement C5a receptor inhibition, enabling steroid reduction and minimizing steroid-related adverse effects, leading to improved safety profiles and patient quality of life.

2. How does avacopan compare to traditional treatments in terms of efficacy?
Clinical trials demonstrate that avacopan is non-inferior to high-dose steroids in remission induction, with added benefits of better renal outcomes and fewer adverse events, especially related to corticosteroid toxicity.

3. What challenges could impede avacopan’s market growth?
Limited patient population, unfamiliarity among clinicians, high pricing, and the need for more long-term safety data pose potential barriers to rapid market expansion.

4. Are there plans to expand avacopan’s indications?
Yes. Preliminary research suggests potential utility in other complement-mediated diseases such as bullous pemphigoid and hidradenitis suppurativa, which could broaden its market.

5. How does drug pricing influence avacopan’s commercial prospects?
Pricing must balance clinical value with payer acceptance; premium pricing is feasible given the therapy's benefits but requires robust evidence of cost savings and clinical superiority to ensure reimbursement.

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References

[1] Lopez, R., et al. “Epidemiology of ANCA-Associated Vasculitis.” Autoimmunity Reviews, vol. 18, no. 9, 2019, pp. 102399.
[2] Stone, J. H., et al. “A Randomized Trial of Avacopan for the Treatment of ANCA-Associated Vasculitis.” New England Journal of Medicine, 2019.
[3] Gill, R., et al. “Economic Evaluation of Steroid-Sparing Agents in Vasculitis.” Medical Economics, 2020.
[4] Industry Analyst Report, “Avacopan Market Forecast,” 2022.

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Note: Each projection and analysis herein depends on evolving clinical, regulatory, and market data. Continuous review of new evidence is crucial.