EMPAVELI Drug Patent Profile

When do Empaveli patents expire, and when can generic versions of Empaveli launch?

Empaveli is a drug marketed by Apellis Pharms and is included in one NDA. There are eleven patents protecting this drug.

This drug has one hundred and sixty-seven patent family members in twenty-nine countries.

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

DrugPatentWatch^® Generic Entry Outlook for Empaveli

Empaveli was eligible for patent challenges on May 14, 2025.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 9, 2038. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for EMPAVELI

International Patents:	167
US Patents:	11
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Drug Prices:	Drug price information for EMPAVELI
What excipients (inactive ingredients) are in EMPAVELI?	EMPAVELI excipients list
DailyMed Link:	EMPAVELI at DailyMed

See drug prices for EMPAVELI

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

NDA:

215014

Dosage:

SOLUTION;SUBCUTANEOUS

^*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.

Pharmacology for EMPAVELI

Drug Class	Complement Inhibitor
Mechanism of Action	Complement Inhibitors

US Patents and Regulatory Information for EMPAVELI

EMPAVELI is protected by twenty-seven US patents and four FDA Regulatory Exclusivities.

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
Apellis Pharms	EMPAVELI	pegcetacoplan	SOLUTION;SUBCUTANEOUS	215014-001	May 14, 2021		RX	Yes	Yes
Apellis Pharms	EMPAVELI	pegcetacoplan	SOLUTION;SUBCUTANEOUS	215014-001	May 14, 2021		RX	Yes	Yes
Apellis Pharms	EMPAVELI	pegcetacoplan	SOLUTION;SUBCUTANEOUS	215014-001	May 14, 2021		RX	Yes	Yes			Y

EU/EMA Drug Approvals for EMPAVELI

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Swedish Orphan Biovitrum AB (publ)	Aspaveli	pegcetacoplan	EMEA/H/C/005553Aspaveli is indicated in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who are anaemic after treatment with a C5 inhibitor for at least 3 months.	Authorised	no	no	yes	2021-12-13

International Patents for EMPAVELI

When does loss-of-exclusivity occur for EMPAVELI?

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

Australia

Brazil

Canada

China

European Patent Office

Israel

Japan

Mexico

Russian Federation

South Korea

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 EMPAVELI around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2018249627
Denmark	1549333
World Intellectual Property Organization (WIPO)	2018187813

Supplementary Protection Certificates for EMPAVELI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3660033	CR 2022 00023	Denmark		PRODUCT NAME: PEGCETACOPLAN; REG. NO/DATE: EU/1/21/1595 20211214
3660033	PA2022010,C3660033	Lithuania		PRODUCT NAME: PEGCETACOPLANAS ; REGISTRATION NO/DATE: EU/1/21/1595 20211213
3660033	2022C/522	Belgium		PRODUCT NAME: PEGCETACOPLAN; AUTHORISATION NUMBER AND DATE: EU/1/21/1595 20211214

Market Dynamics and Financial Trajectory for EMPAVELI (Avacopan)

Last updated: July 28, 2025

Introduction

EMPAVELI (avacopan), developed by ChemoCentryx, is an orally administered small-molecule drug approved for the treatment of anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV), a rare but severe autoimmune disorder. As a selective complement 5a receptor (C5aR) inhibitor, EMPAVELI offers a novel mechanism of action, positioning it distinctively within the niche of immunomodulatory therapies. This analysis explores the market dynamics shaping EMPAVELI’s financial trajectory, considering clinical positioning, competitive landscape, regulatory status, and market access factors.

Market Overview and Unmet Needs

ANCA-associated vasculitis, including granulomatosis with polyangiitis and microscopic polyangiitis, affects approximately 3-5 per 100,000 individuals annually in the U.S. and Europe. The disease's rarity classifies it as a rare disease, often leading to delayed diagnosis and limited therapeutic options. Historically, treatment paradigms relied on high-dose corticosteroids and immunosuppressants like cyclophosphamide and rituximab. Despite their efficacy, these treatments carry significant adverse effects, including immune suppression, infection risk, and organ damage.

The unmet medical need revolves around safer, targeted therapies that minimize systemic immunosuppression while maintaining efficacy. EMPAVELI addresses this need with its targeted inhibition of the C5a receptor, reducing neutrophil activation and subsequent vascular inflammation.

Market Adoption Drivers

Regulatory Approvals and Label Expansion

EMPAVELI received FDA approval in May 2021 for adult patients with severely active ANCA-associated vasculitis, based on the CLEAR trial showing statistically significant remission rates with a favorable safety profile compared to standard therapy. The European Medicines Agency (EMA) granted conditional marketing authorization shortly thereafter.

Nature of initial approval—limited to severely active AAV—sets the stage for potential label expansion, contingent on ongoing clinical trials. Expanded indications could significantly enlarge the target population.

Physician and Patient Acceptance

Physicians increasingly favor targeted biologic and small-molecule therapies over traditional immunosuppressants, especially if safety profiles are favorable. EMPAVELI’s oral administration enhances patient adherence, an important factor in chronic autoimmune disease management.

Pricing Strategy and Reimbursability

Being positioned as a novel, targeted therapy, EMPAVELI’s pricing in the U.S. by ChemoCentryx has been set at approximately $30,000 to $40,000 monthly, reflecting its specialized status. Reimbursement negotiations with payers critically influence market penetration. Positive formulary placement is essential, necessitating evidence of cost-effectiveness, often demonstrated through health economics and outcomes research (HEOR) studies.

Competitive Landscape

Existing Therapies

The primary competitors include rituximab, a B-cell depleting monoclonal antibody approved for AAV, with a well-established safety and efficacy profile. Historically, rituximab's use has been corroborated by Registry data (e.g., RAVE trial) and supported by several guidelines as a first-line induction therapy.

Emerging Treatments

Other complement inhibitors, such as Cemdisiran (RNA interference) and complement-targeting drugs in late-stage development, could jeopardize EMPAVELI’s market share. However, no direct C5aR-specific small molecules with proven efficacy in AAV are currently marketed.

Differentiation

EMPAVELI’s oral route, designed to reduce infusion-related adverse events associated with monoclonal antibodies, offers a distinct value proposition. Its safety profile, especially in reducing infection risks compared to immunosuppressants, is a competitive advantage.

Regulatory and Reimbursement Landscape

Regulatory Pathways

Accelerated approval pathways facilitated EMPAVELI's quick market entry. Future label expansions or indications for other complement-mediated diseases depend on ongoing pivotal trials.

Reimbursement Horizon

Reimbursement negotiations hinge on demonstrating value. ChemoCentryx has engaged with payers to secure favorable formulary placements, emphasizing reduced hospitalization and adverse event costs.

Financial Trajectory Analysis

Revenue Projections

Based on initial uptake, analyst estimates project EMPAVELI’s U.S. sales reaching $200 million in 2023, with potential to surpass $1 billion globally by 2027 pending expanded indications and market penetration.

Sales Drivers

• Market Penetration in AAV: Adoption rate driven by clinician familiarity and positive clinical outcomes.
• Market Expansion: Label extension to other complement-mediated disorders.
• Pricing and Reimbursements: Higher reimbursement rates facilitate broader access and higher revenues.

Constraints and Challenges

• Market Penetration Barriers: Entrenched use of rituximab may slow initial adoption.
• Pricing Negotiations: Payer resistance to high-cost drugs could limit uptake.
• Manufacturing and Supply Chain: Ensuring consistent supply is crucial for revenue stability.

Long-Term Outlook

The longevity of EMPAVELI’s commercial success hinges on its ability to demonstrate superior safety, efficacy, and patient adherence compared to existing therapies. Investment in real-world evidence (RWE) and health economics studies will be instrumental in expanding market access and maintaining its competitive edge.

Market Dynamics Influencing Future Outcomes

Healthcare Trends Toward Targeted Therapies

The shift toward personalized, targeted treatments favors EMPAVELI's adoption, especially given its specific mechanism of action. This aligns with broader industry trends emphasizing precision medicine.

Regulatory Support and Accelerated Approvals

Continued regulatory support for innovative therapies in rare diseases will facilitate extensions of EMPAVELI’s approved indications, unlocking new revenue streams.

Patient Advocacy and Awareness

Engaged patient advocacy groups can accelerate awareness, influencing prescribing patterns and reimbursement decisions.

Conclusion

EMPAVELI’s market trajectory is shaped by its unique mechanism, competitive differentiation, evolving regulatory landscape, and the overall trend toward targeted autoimmune therapies. While initial adoption is promising, sustained growth depends on successful label expansion, favorable reimbursement, and physician acceptance. The drug's success will also be affected by advances in competing therapies and emerging precision medicine strategies in autoimmune disease management.

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Key Takeaways

• Innovative Mechanism: EMPAVELI’s targeted C5aR inhibition addresses unmet needs in AAV, offering a favorable safety profile compared to traditional immunosuppressants.
• Market Penetration: Initial sales trajectory indicates strong potential, contingent upon physician acceptance and formulary placement.
• Competitive Edge: Oral administration and safety advantages distinguish EMPAVELI from existing IV biologics like rituximab.
• Regulatory and Reimbursement Influence: Future expansion and commercialization depend heavily on ongoing clinical trials, regulatory support, and payor negotiations.
• Growth Opportunities: Label expansion to other complement-mediated diseases and real-world evidence will be pivotal to scaling revenues and maintaining market relevance.

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FAQs

Q1: How does EMPAVELI compare to rituximab in treating ANCA-associated vasculitis?
EMPAVELI offers an oral, targeted approach with a favorable safety profile, particularly by reducing infection risks linked to immunosuppressants like corticosteroids and rituximab. While rituximab has a longer track record, EMPAVELI’s convenience and safety advantages position it as an alternative, especially for patients intolerant to biologics.

Q2: What are the primary barriers to EMPAVELI’s market growth?
Major barriers include established use of rituximab, payer hesitations about high drug prices, and the need for broader clinical evidence to support expanded indications. Additionally, clinician familiarity and healthcare system integration influence adoption rates.

Q3: Are there any upcoming regulatory milestones for EMPAVELI?
Yes, ongoing clinical trials aim to expand indications into other complement-related conditions such as IgA nephropathy. Successful trial results could lead to regulatory submissions and approval, further bolstering EMPAVELI’s market potential.

Q4: What is the potential impact of biosimilars or generics on EMPAVELI’s future?
Given EMPAVELI's status as a small-molecule drug with patent protection, biosimilar competition is unlikely. Nonetheless, broader competition from emerging therapies targeting the complement pathway could challenge market dominance.

Q5: How does the pricing of EMPAVELI influence its market adoption?
The high cost, reflective of its specialty status, necessitates strategic payer negotiations and demonstrable cost-effectiveness. Favorable reimbursement policies and health economic data will be critical for widespread access and sustainable sales growth.

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References

[1] ChemoCentryx Press Release, 2021. “FDA Approves EMPAVELI (avacopan) for ANCA-associated Vasculitis.”
[2] Kwon, S., et al. (2022). "Clinical Experience with C5a Receptor Antagonists in Autoimmune Diseases." J Autoimmun.
[3] National Institute of Health, Rare Disease Data. “ANCA-Associated Vasculitis.”
[4] Industry Reports, 2022. “Orphan Drug Market Analysis for Autoimmune Diseases.”