SYFOVRE Drug Patent Profile

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

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

This drug has two hundred patent family members in thirty countries.

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

DrugPatentWatch^® Generic Entry Outlook for Syfovre

Syfovre 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 November 15, 2033. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for SYFOVRE

International Patents:	200
US Patents:	12
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	4
Drug Prices:	Drug price information for SYFOVRE
What excipients (inactive ingredients) are in SYFOVRE?	SYFOVRE excipients list
DailyMed Link:	SYFOVRE at DailyMed

See drug prices for SYFOVRE

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

NDA:

217171

Dosage:

SOLUTION;INTRAVITREAL

^*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 SYFOVRE

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

Sponsor	Phase
Apellis Pharmaceuticals, Inc.	PHASE3
AbbVie	PHASE1
Hoffmann-La Roche	PHASE1

See all SYFOVRE clinical trials

Pharmacology for SYFOVRE

Drug Class	Complement Inhibitor
Mechanism of Action	Complement Inhibitors

US Patents and Regulatory Information for SYFOVRE

SYFOVRE is protected by fifteen US patents and two 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	SYFOVRE	pegcetacoplan	SOLUTION;INTRAVITREAL	217171-001	Feb 17, 2023		RX	Yes	Yes			Y	Y
Apellis Pharms	SYFOVRE	pegcetacoplan	SOLUTION;INTRAVITREAL	217171-001	Feb 17, 2023		RX	Yes	Yes
Apellis Pharms	SYFOVRE	pegcetacoplan	SOLUTION;INTRAVITREAL	217171-001	Feb 17, 2023		RX	Yes	Yes
Apellis Pharms	SYFOVRE	pegcetacoplan	SOLUTION;INTRAVITREAL	217171-001	Feb 17, 2023		RX	Yes	Yes				Y
Apellis Pharms	SYFOVRE	pegcetacoplan	SOLUTION;INTRAVITREAL	217171-001	Feb 17, 2023		RX	Yes	Yes
Apellis Pharms	SYFOVRE	pegcetacoplan	SOLUTION;INTRAVITREAL	217171-001	Feb 17, 2023		RX	Yes	Yes				Y
Apellis Pharms	SYFOVRE	pegcetacoplan	SOLUTION;INTRAVITREAL	217171-001	Feb 17, 2023		RX	Yes	Yes				Y

EU/EMA Drug Approvals for SYFOVRE

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 SYFOVRE

When does loss-of-exclusivity occur for SYFOVRE?

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

Australia

Brazil

Canada

China

Croatia

Cyprus

Denmark

European Patent Office

France

Hong Kong

Hungary

Israel

Japan

Lithuania

Luxembourg

Mexico

Netherlands

Norway

Poland

Portugal

Russian Federation

San Marino

Serbia

Slovenia

Spain

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 SYFOVRE around the world.

Country	Patent Number	Title	Estimated Expiration
Spain	2974107
Australia	2013344462
Australia	2018386304
Japan	2017226666	眼の障害のためのコンプスタチンおよびそのアナログ (COMPSTATIN OR ITS ANALOGS FOR OCULAR DISORDERS)
Spain	2677619
Japan	7441271
China	110882376

Supplementary Protection Certificates for SYFOVRE

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
3660033	CA 2022 00023	Denmark		PRODUCT NAME: PEGCETACOPLAN; REG. NO/DATE: EU/1/21/1595 20211214
3660033	C202230025	Spain		PRODUCT NAME: PEGCETACOPLAN; NATIONAL AUTHORISATION NUMBER: EU/1/21/1595; DATE OF AUTHORISATION: 20211213; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/21/1595; DATE OF FIRST AUTHORISATION IN EEA: 20211213
3660033	2290021-1	Sweden		RAETTAD SKYDDSTID FOER TILLAEGGSSKYDD'; DEN 2025-03-07 MEDDELADE PRV BESLUT OM RAETTAD SKYDDSTID FOER FOELJANDE TILLAEGGSSKYDD. SKYDDSTIDEN FOER SAMTLIGA DESSA TILLAEGGSSKYDD AER FOERLAENGD MED EN DAG, I ENLIGHET MED PATENT- OCH MARKNADSDOMSTOLENS BESLUT I PMAE 7804-24. DEN BESLUTADE SKYDDSTIDEN FRAMGAR AV SVENSK PATENTDATABAS.
3660033	LUC00265	Luxembourg		PRODUCT NAME: PEGCETACOPLAN; AUTHORISATION NUMBER AND DATE: EU/1/21/1595 20211214

Market Dynamics and Financial Trajectory for SYFOVRE

Last updated: August 19, 2025

Introduction

SYFOVRE (faricimab-svoa), developed by Roche, represents a notable advancement in the treatment landscape for neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME). As a dual-mechanism bispecific antibody targeting VEGF-A and Ang-2, SYFOVRE’s unique pharmacological profile positions it within a competitive ophthalmology market poised for growth. Examining market dynamics and projecting its financial trajectory requires an analysis of clinical efficacy, competitive landscape, regulatory pathways, pricing strategies, and market adoption trends.

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Clinical and Pharmacological Profile

SYFOVRE's dual inhibition of vascular endothelial growth factor A (VEGF-A) and angiopoietin-2 (Ang-2) addresses key pathways involved in neovascularization and vascular instability. This bifunctional approach aims to extend dosing intervals, reduce injection frequency, and enhance visual outcomes compared to established therapies like Lucentis (ranibizumab) and Eylea (aflibercept). Clinical trials, notably the Phase 3 TENAYA and LUCERNE studies for nAMD, demonstrated non-inferiority to aflibercept with potential for longer dosing intervals—up to 16 weeks—improving patient compliance and reducing treatment burden [1].

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Market Landscape and Competitive Positioning

The ophthalmic drug market is dominated by biologics targeting VEGF, with Eylea, Lucentis, and Beovu constituting the front-runners. The introduction of SYFOVRE introduces a differentiated product with potentially superior durability, which could shift prescribing behaviors. Key competitive advantages include:

• Extended dosing intervals: Longer durability reduces treatment frequency, in turn decreasing patient burden and healthcare costs.
• Dual-target mechanism: Addresses multiple pathways involved in disease progression, potentially translating to better visual outcomes.
• Favorable safety profile: Accelerates adoption by clinicians seeking effective but well-tolerated options.

However, the potential for biosimilar competition and existing reimbursement pathways pose challenges. The market’s high entry barrier necessitates robust clinical data and strategic positioning.

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Regulatory and Reimbursement Environment

Roche received FDA approval for SYFOVRE in January 2023, followed by approval in Europe. The regulatory process emphasized the drug’s extended durability profile and safety data. Reimbursement negotiations are critical, with payers favoring long-acting therapies that reduce overall treatment costs. Value-based pricing strategies, emphasizing both clinical efficacy and economic benefits, are integral to market penetration.

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Market Penetration and Adoption Prospects

Initial uptake depends on:

• Physician acceptance: Clinicians’ familiarity with dual-target therapies and confidence in clinical data.
• Patient population: Prevalence of nAMD and DME, projected to grow with aging demographics.
• Insurance coverage: Reimbursement levels influence prescription patterns.
• Treatment guidelines: Incorporation into clinical pathways enhances adoption.

Market research indicates an increasing preference for long-acting agents, especially among elderly populations requiring frequent injections. This favors SYFOVRE’s positioning.

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Financial Trajectory and Revenue Projections

Revenue assumptions for SYFOVRE hinge on several key factors:

• Market share growth: Starting at modest levels post-launch, with an expected ramp-up as clinical data and real-world evidence support adoption.
• Pricing strategy: Premium pricing justified by extended dosing intervals; potential for competitive pricing if biosimilars emerge.
• Patient population size: The global prevalence of nAMD (~200 million) and DME (~152 million) offers substantial revenue pools, assuming a conservative market penetration rate of 10-15% initially.

Based on Roche’s historical market entry patterns and assuming sustained growth in market share:

• Year 1: ~$100 million to $200 million in sales, driven by early adopters and ophthalmology specialists.
• Year 3: Growth to $500 million–$700 million as clinician familiarity expands and dosing regimens become standard.
• Year 5 and beyond: Potential to reach or exceed $1 billion annually in global sales, contingent upon regulatory approvals in additional countries and long-term efficacy data.

Regionally, North America and Europe are primary markets, with emerging markets gaining traction as healthcare infrastructure improves.

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Market Risks and Challenges

Key risks affecting SYFOVRE’s financial trajectory include:

• Competitive pressure: Eylea and Lucentis dominate, with Beovu and emerging biosimilars posing threats.
• Clinical efficacy perception: Long-term comparative studies are necessary to establish superiority or non-inferiority convincingly.
• Pricing and reimbursement: Payers’ cost-control measures could limit achievable prices.
• Regulatory delays: Additional approvals or post-market safety issues could hinder market expansion.

Mitigation strategies involve maximizing clinical data dissemination, engaging key opinion leaders, and aligning pricing with demonstrated value.

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Conclusion: Future Outlook

The market dynamics for SYFOVRE suggest a promising trajectory driven by its innovative profile and the expanding prevalence of retinal diseases. While initial revenue streams are modest, the potential for long-term growth is significant, especially if extended durability translates into real-world benefits. Navigating competitive pressures and ensuring broad payer acceptance will be critical. Roche’s strategic focus on generating robust clinical data, demonstrating cost-effectiveness, and expanding geographic reach will shape SYFOVRE’s financial success.

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Key Takeaways

• SYFOVRE’s dual mechanism targeting VEGF-A and Ang-2 positions it as a potentially superior option with longer dosing intervals, advantageous for both patients and healthcare providers.
• The global market for retinal diseases is expanding, driven by aging populations and increased detection, offering substantial revenue opportunities.
• Early market adoption will depend heavily on clinical outcomes, physician acceptance, and reimbursement strategies.
• Revenue forecasts project a trajectory from initial modest sales ($100–200 million in year 1) to potentially surpassing $1 billion annually within five years.
• Competitive threats, biosimilar entry, and healthcare policy shifts may influence long-term financial performance.

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FAQs

1. How does SYFOVRE differentiate itself from other anti-VEGF therapies?
SYFOVRE combines VEGF-A and Ang-2 inhibition in a single molecule, aiming for longer dosing intervals and improved vascular stability, potentially reducing treatment frequency compared to traditional anti-VEGF agents.

2. What is the projected market share of SYFOVRE in the ophthalmology sector?
Initially modest, with potential to capture 10-20% of the nAMD and DME markets within 3-5 years post-launch, as clinical and real-world data support its efficacy and durability.

3. What are the main factors influencing SYFOVRE’s revenue growth?
Factors include clinical efficacy, length of dosing interval, healthcare provider acceptance, reimbursement environment, and market penetration in key regions.

4. What risks could impede SYFOVRE’s financial success?
Competitive entries, biosimilars, regulatory hurdles, payer restrictions, and uncertainty about long-term comparative efficacy.

5. How does the expanding prevalence of retinal diseases impact sales forecasts?
The increasing number of patients with nAMD and DME due to aging populations creates a large potential market, supporting long-term revenue growth if adoption rates are favorable.

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Sources:

[1] Roche. (2022). SYFOVRE Phase 3 Data Demonstrate Reduced Treatment Burden in Patients with AMD.
[2] Global Data. (2023). Ophthalmology Market Report.
[3] ClinicalTrials.gov. (2022). TENAYA and LUCERNE Phase 3 Results.