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 eleven patents protecting this drug.

This drug has one hundred and eighty-five patent family members in twenty-eight 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 will be eligible for patent challenges on May 14, 2025. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

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:	185
US Patents:	11
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
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.

Pharmacology for SYFOVRE

Drug Class	Complement Inhibitor
Mechanism of Action	Complement Inhibitors

US Patents and Regulatory Information for SYFOVRE

SYFOVRE is protected by fourteen 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

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/005553 Aspaveli 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

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
European Patent Office	2662089	Compstatine et ses analogues pour troubles oculaires (Compstatin and analogs thereof for eye disorders)
Russian Federation	2015119165	КЛЕТОЧНО-РЕАКТИВНЫЕ АНАЛОГИ КОМПСТАТИНА, АНАЛОГИ КОМПСТАТИНА ДЛИТЕЛЬНОГО ДЕЙСТВИЯ ИЛИ АНАЛОГИ КОМПСТАТИНА НАЦЕЛЕННОГО ДЕЙСТВИЯ, И СВЯЗАННЫЕ С НИМИ КОМПОЗИЦИИ И СПОСОБЫ
Israel	229368
Israel	304291

Supplementary Protection Certificates for SYFOVRE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3660033	2022017	Norway		PRODUCT NAME: PEGCETACOPLAN; REG. NO/DATE: EU/1/21/1595 20211216
3660033	C03660033/01	Switzerland		PRODUCT NAME: PEGCETACOPLAN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68674 23.03.2023
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	22C1025	France		PRODUCT NAME: PEGCETACOPLAN; REGISTRATION NO/DATE: EU/1/21/1595 20211214

Market Dynamics and Financial Trajectory for SYFOVRE

Introduction

SYFOVRE, developed by Apellis Pharmaceuticals, is a groundbreaking drug approved for the treatment of geographic atrophy (GA), a form of vision loss associated with age-related macular degeneration. Since its launch, SYFOVRE has demonstrated robust market performance and significant financial growth.

Market Leadership in Geographic Atrophy

SYFOVRE has established itself as the market leader in the treatment of GA. In the second quarter of 2024, it delivered over 84,000 doses to physician practices, including more than 79,000 commercial vials and approximately 5,000 samples. This trend continued into the third quarter, with over 88,500 doses delivered, comprising around 84,500 commercial vials and 4,000 samples[1][2].

Revenue Growth

The financial performance of SYFOVRE has been impressive. In the second quarter of 2024, it generated $154.6 million in U.S. net product revenue, contributing significantly to Apellis Pharmaceuticals' total revenue of $199.7 million for the quarter. This represents a substantial increase from the second quarter of 2023, when SYFOVRE revenue was $67.3 million[1][3].

In the third quarter of 2024, SYFOVRE continued its growth trajectory, with U.S. net product revenue of $152.0 million, despite a slight decline in net selling price due to increased gross-to-net adjustments. This still marked a 7% quarter-over-quarter growth in commercial vial demand[2][5].

Total Sales and Administration

Since its launch, SYFOVRE has achieved over $0.5 billion in sales, with more than 330,000 injections estimated to have been administered through June 2024, and over 420,000 by September 2024, including clinical trials. This rapid adoption underscores the drug's strong market position and the significant need for effective GA treatments[1][3].

Formulary Inclusions and Payer Coverage

SYFOVRE has gained favorable formulary positions, which are crucial for its continued success. Effective July 1, 2024, two large national pharmacy benefit managers made SYFOVRE the preferred product on their commercial formularies. Additionally, starting January 1, 2025, a large Medicare Advantage plan will make SYFOVRE the only preferred product on its formulary[1][2].

Clinical and Safety Profile

Despite some initial concerns about side effects, particularly occlusive retinal vasculitis, Apellis has maintained that these cases are rare, affecting about 0.01% of injections. The company has continued to update doctors on new cases and has indicated that a faulty needle might be related to the issue. This transparency and the drug's overall efficacy profile have helped in maintaining physician confidence and patient demand[4].

European Market and Regulatory Updates

Apellis has been working to expand SYFOVRE's reach into the European market. However, the company faced a negative opinion from the Committee for Medicinal Products for Human Use (CHMP) in June and September 2024, which has delayed the marketing authorization application. Despite this, Apellis remains committed to re-examining the application and expects a final decision in the fourth quarter of 2024[1][2].

Financial Projections and Cash Flow

Apellis Pharmaceuticals is optimistic about its financial future, driven largely by SYFOVRE's performance. The company has a clear line of sight to positive cash flow and is strengthening its balance sheet. With cash and cash equivalents of $396.9 million as of September 30, 2024, Apellis is confident that its projected revenues and cash will be sufficient to fund operations until it reaches positive cash flow[3][5].

Expansion into New Indications

In addition to its success in GA, Apellis is exploring new indications for SYFOVRE. The company is on track to file a supplemental New Drug Application (sNDA) seeking approval for pegcetacoplan in C3G (Complement 3 glomerulopathy) and primary IC-MPGN (Immune Complex Membranoproliferative Glomerulonephritis) based on positive Phase 3 VALIANT study results. This expansion could further bolster SYFOVRE's market presence and revenue potential[5].

Competitive Position

Apellis's contracting strategies and the drug's safety profile are expected to support its competitive position. The company's focus on direct-to-consumer campaigns and the favorable view of SYFOVRE's clinical profile by physicians are also key factors in driving growth in new patient starts[3].

Challenges and Future Outlook

While SYFOVRE faces some challenges, such as the recent side effect concerns and regulatory hurdles in Europe, the drug's overall performance and market demand remain strong. Apellis's strategic focus on SYFOVRE and its expansion into new indications position the company for continued growth and market dominance.

Key Takeaways

• Market Leadership: SYFOVRE is the leading treatment for geographic atrophy, delivering over 84,000 doses in Q2 2024 and over 88,500 doses in Q3 2024.
• Revenue Growth: Generated $154.6 million in Q2 2024 and $152.0 million in Q3 2024 in U.S. net product revenue.
• Formulary Inclusions: Preferred product on several major formularies, including a large Medicare Advantage plan starting January 1, 2025.
• Clinical Profile: Despite rare side effects, the drug's efficacy and safety profile remain strong.
• European Market: Facing regulatory delays but expecting a final decision in Q4 2024.
• Financial Projections: Clear line of sight to positive cash flow with sufficient projected revenues and cash.

FAQs

What is SYFOVRE used for?

SYFOVRE is used for the treatment of geographic atrophy (GA), a form of vision loss associated with age-related macular degeneration.

How has SYFOVRE performed financially?

SYFOVRE generated $154.6 million in U.S. net product revenue in Q2 2024 and $152.0 million in Q3 2024, contributing significantly to Apellis Pharmaceuticals' total revenue.

What are the side effects associated with SYFOVRE?

SYFOVRE has been linked to rare cases of occlusive retinal vasculitis, affecting about 0.01% of injections. However, most cases have been reported as recoverable.

Is SYFOVRE covered by major formularies?

Yes, SYFOVRE has been included as a preferred product on several major formularies, including two large national pharmacy benefit managers and a large Medicare Advantage plan starting January 1, 2025.

What are Apellis's plans for expanding SYFOVRE's indications?

Apellis plans to file an sNDA seeking approval for pegcetacoplan in C3G and primary IC-MPGN based on positive Phase 3 VALIANT study results.

Sources

1. Apellis Pharmaceuticals Reports Second Quarter 2024 Financial Results - Apellis Pharmaceuticals.
2. Apellis Pharmaceuticals Reports Third Quarter 2024 Financial Results - Apellis Pharmaceuticals.
3. Earnings call: Apellis Pharmaceuticals reports growth and market confidence - Investing.com.
4. Apellis sales numbers show steady demand for new eye drug - Biopharma Dive.
5. Apellis Pharmaceuticals Reports Third Quarter 2024 Financial Results - GlobeNewswire.