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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 ten patents protecting this drug.

This drug has one hundred and forty-five patent family members in twenty-six 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 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 April 9, 2038. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for EMPAVELI

International Patents:	145
US Patents:	10
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 fifteen US patents and three 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			Y
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
Apellis Pharms	EMPAVELI	pegcetacoplan	SOLUTION;SUBCUTANEOUS	215014-001	May 14, 2021		RX	Yes	Yes			Y	Y
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/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 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
Portugal	1960422
European Patent Office	2707384	ANALOGUES DE LA COMPSTATINE CIBLÉS, À LONGUE DURÉE D'ACTION, RÉACTIFS AUX CELLULES, ET LEURS UTILISATIONS (CELL-REACTIVE, LONG-ACTING, OR TARGETED COMPSTATIN ANALOGS AND USES THEREOF)
Slovenia	1960422
Russian Federation	2013149956	КЛЕТОЧНО-РЕАКТИВНЫЕ АНАЛОГИ КОМПСТАТИНА, АНАЛОГИ КОМПСТАТИНА ДЛИТЕЛЬНОГО ДЕЙСТВИЯ ИЛИ АНАЛОГИ КОМПСТАТИНА НАЦЕЛЕННОГО ДЕЙСТВИЯ И ИХ ПРИМЕНЕНИЕ
Japan	2013531030

Supplementary Protection Certificates for EMPAVELI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3660033	122022000034	Germany		PRODUCT NAME: PEGCETACOPLAN; REGISTRATION NO/DATE: EU/1/21/1595 20211213
3660033	PA2022010	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	CR 2022 00023	Denmark		PRODUCT NAME: PEGCETACOPLAN; REG. NO/DATE: EU/1/21/1595 20211214
3660033	2022017	Norway		PRODUCT NAME: PEGCETACOPLAN; REG. NO/DATE: EU/1/21/1595 20211216

EMPAVELI Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for EMPAVELI

Introduction

EMPAVELI, developed by Apellis Pharmaceuticals, is a significant player in the treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH) and other rare diseases. Here, we delve into the market dynamics and financial trajectory of EMPAVELI, highlighting its performance, user compliance, and future outlook.

Product Overview

EMPAVELI, or pegcetacoplan, is an investigational targeted C3 therapy designed to treat PNH and other complement-mediated diseases. It has shown promising results in clinical trials and has been approved for the treatment of PNH, with ongoing studies for additional indications such as C3 glomerulopathy (C3G) and immunoglobulin M-associated membranoproliferative glomerulonephritis (IC-MPGN)[1][3][4].

Revenue Performance

The revenue generated by EMPAVELI has been steadily increasing, although at a slower pace compared to Apellis's other product, SYFOVRE.

• 2023 Financial Results: EMPAVELI generated $91 million in U.S. net product revenue for the full year 2023, with $24.4 million in the fourth quarter alone[1].
• Q2 2024: The product generated $24.5 million in U.S. net product revenue, maintaining a consistent revenue stream[2].
• Q3 2024: EMPAVELI continued to show a slight increase, generating $24.6 million in U.S. revenue, a 3% year-over-year increase[3].

Patient Compliance and Uptake

One of the key strengths of EMPAVELI is its high patient compliance rate.

• Compliance Rate: EMPAVELI has consistently maintained a high compliance rate of 97%, indicating strong patient adherence to the treatment[1][3].
• EMPAVELI Injector: Following its approval in October 2023, the EMPAVELI Injector is now used by approximately 60% of existing EMPAVELI patients and over 90% of new patients, further enhancing patient convenience and compliance[1].

Clinical Trials and Future Indications

Apellis is actively expanding the therapeutic scope of EMPAVELI through ongoing clinical trials.

• Phase 3 VALIANT Study: The company is awaiting topline data from the Phase 3 VALIANT study for the treatment of C3G and IC-MPGN, expected in mid-2024. This study is crucial for potential future approvals and market expansion[1][4].
• Supplemental NDA: Apellis plans to file a supplemental New Drug Application (NDA) with the FDA for EMPAVELI in these new indications, which could significantly boost its market presence[3].

Market Position and Competition

EMPAVELI operates in a niche market with limited competition, particularly in the treatment of PNH.

• Market Dominance: With no new competition expected for at least four years, Apellis remains confident in the long-term outlook for EMPAVELI[3].
• Expansion Plans: The company is expanding its nephrology infrastructure in preparation for the launch of EMPAVELI into new indications, further solidifying its market position[3].

Financial Outlook

While EMPAVELI contributes significantly to Apellis's revenue, the company's overall financial health is also influenced by its other product, SYFOVRE, and ongoing R&D activities.

• Cash Reserves: As of the latest reports, Apellis has substantial cash reserves, with $360.1 million in cash and cash equivalents, ensuring sufficient funding for operations and future developments[2][4].
• Operational Breakeven: The company aims to achieve operational breakeven, with a net cash burn of about $10 million, indicating a move towards financial stability[3].

Key Metrics and Insights

• Revenue Growth: Despite the slower growth compared to SYFOVRE, EMPAVELI's revenue has been stable and increasing, reflecting its established market presence.
• R&D Expenses: While R&D expenses remain significant, they have decreased in recent quarters, contributing to a narrower net loss for the company[2][3].

Conclusion

EMPAVELI has established itself as a critical treatment option for PNH and is poised for further growth with potential approvals in new indications. The high patient compliance rate, upcoming clinical trial results, and strategic expansion plans position EMPAVELI for continued success in the market.

Key Takeaways

• Stable Revenue: EMPAVELI has generated consistent revenue, with a 3% year-over-year increase in Q3 2024.
• High Compliance: The product maintains a 97% patient compliance rate.
• Future Indications: Ongoing clinical trials and planned supplemental NDA filings could expand its therapeutic scope.
• Market Position: EMPAVELI enjoys a strong market position with limited competition.
• Financial Stability: Apellis has sufficient cash reserves and aims for operational breakeven.

FAQs

1. What is EMPAVELI used for? EMPAVELI, or pegcetacoplan, is primarily used for the treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH) and is under investigation for other complement-mediated diseases like C3 glomerulopathy (C3G) and immunoglobulin M-associated membranoproliferative glomerulonephritis (IC-MPGN)[1][3][4].

2. What is the patient compliance rate for EMPAVELI? EMPAVELI has a high patient compliance rate of 97%, indicating strong patient adherence to the treatment[1][3].

3. What are the upcoming milestones for EMPAVELI? Key upcoming milestones include the topline data from the Phase 3 VALIANT study and the filing of a supplemental NDA for new indications[1][3][4].

4. How does EMPAVELI contribute to Apellis's revenue? EMPAVELI generates significant revenue for Apellis, although at a slower pace compared to SYFOVRE. It contributed $91 million in U.S. net product revenue for the full year 2023[1][2].

5. What is the market outlook for EMPAVELI? The market outlook for EMPAVELI is positive, with no new competition expected for at least four years and plans for expansion into new indications[3].

Sources

1. Apellis Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results - Apellis Pharmaceuticals[1].
2. Apellis Pharmaceuticals Reports Second Quarter 2024 Financial Results - StockTitan[2].
3. Earnings call: Apellis Pharmaceuticals Q3 2024 results show promise - Investing.com[3].
4. Apellis Pharmaceuticals Reports First Quarter 2024 Financial Results - BioSpace[4].