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EMPAVELI

NDA

PEGCETACOPLAN | N215014 | APELLIS PHARMACEUTICALS INC

1 strength11 unique patents6 unique exclusivities

Patent Timeline

11 unique patents, 6 exclusivities by expiration date

Active (11)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

Today

Dec. 4, 2027

Dec. 4, 2027

Nov. 18, 2027

Nov. 15, 2033

Aug. 2, 2033

Nov. 15, 2033

Apr. 9, 2038

Nov. 15, 2033

Jan. 13, 2033

Dec. 9, 2038

Dec. 14, 2038

M-288

Feb. 8, 2026

NCE

May. 14, 2026

ODE-351

May. 14, 2028

I-972

Jul. 28, 2028

ODE-533

Jul. 28, 2032

ODE-539

Jul. 28, 2032

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

15 trials from ClinicalTrials.gov — 3 recruiting, 9 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Phase 2, Randomized, Placebo Controlled, Multicenter, Masked Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacodynamics of Multidose APL 3007 in Combination With Syfovre/Pegcetacoplan (APL-2) in Patients Diagnosed With Geographic Atrophy Secondary to Age Related Macular Degeneratio NCT07215390	Phase 2	Recruiting	Apellis Pharmaceuticals, Inc.	240	2025-06-23 → 2027-11
Real-World Effectiveness and Safety of Pegcetacoplan in Patients With C3G or IC-MPG: A Multi-Country Study NCT07746895	Phase 4	Recruiting	Swedish Orphan Biovitrum	150	2026-08-05 → 2032-01-31
A Study of Pegcetacoplan in Pediatric Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)NCT04901936	Phase 2	Recruiting	Apellis Pharmaceuticals, Inc.	12	2021-02-04 → 2028-12
A Phase I Study to Assess the Safety of Pegcetacoplan (APL-2) as an Add-On to Standard of Care in Subjects With PNH NCT02264639	Phase 1	Completed	Apellis Pharmaceuticals, Inc.	9	2015-02-23 → 2018-10-22
A Phase IIa Study to Assess the Safety, Efficacy, and Pharmacokinetics of Subcutaneously Administered Pegcetacoplan (APL-2) in Subjects With PNH NCT03593200	Phase 2	Completed	Apellis Pharmaceuticals, Inc.	4	2018-08-16 → 2019-10-22
Study to Evaluate the Efficacy and Safety of APL-2 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)NCT03500549	Phase 3	Completed	Apellis Pharmaceuticals, Inc.	80	2018-06-14 → 2020-08-13
Study of Pegcetacoplan (APL-2) Therapy in Patients With Geographic Atrophy NCT02503332	Phase 2	Completed	Apellis Pharmaceuticals, Inc.	246	2015-09-24 → 2018-01-17
A Study to Compare the Efficacy and Safety of Intravitreal APL-2 Therapy With Sham Injections in Patients With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration NCT03525613	Phase 3	Completed	Apellis Pharmaceuticals, Inc.	637	2018-08-31 → 2022-06-28
Pegcetacoplan Long Term Safety and Efficacy Extension Study NCT03531255	Phase 3	Completed	Apellis Pharmaceuticals, Inc.	137	2018-08-27 → 2026-05-19
Study to Evaluate the Safety of Intravitreal APL-2 in Patients Diagnosed With Geographic Atrophy NCT03777332	Phase 1	Completed	Apellis Pharmaceuticals, Inc.	19	2018-11-05 → 2021-04-01

Source: ClinicalTrials.gov. Trials matched by ingredient name.

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$3371.42

Highest Price

$4541.81

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
73606-0010-01EMPAVELI 1080MG/20ML INJ	$3371.42	Big4	APL Sales I LLC	12/14/2026
73606-0010-01EMPAVELI 1080MG/20ML INJ	$4541.81	FSS	APL Sales I LLC	12/14/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Empaveli (2024)

Total Spending

$28.6M

Total Claims

704

Beneficiaries

Avg Cost/Unit

$240.76

Spending Trend

$4.0M(2021)→$16.5M(2022)→$25.2M(2023)→$28.6M(2024)

YoY Change:+2.4%

5yr CAGR:+2.0%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Aug 21, 2026	SUPPL -12	View Letter (PDF)
Jul 29, 2025	SUPPL -11	View Letter (PDF)
Jun 12, 2025	SUPPL -10	View Letter (PDF)
Oct 8, 2024	SUPPL -8	View Letter (PDF)
Feb 9, 2024	SUPPL -6	View Letter (PDF)
Sep 29, 2023	SUPPL -3	View Letter (PDF)
May 17, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1080MG/20ML (54MG/ML)

RLD

27 patents6 exclusivities▴

SOLUTION;SUBCUTANEOUS | Approved: May 14, 2021

Patents (27)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7888323	Dec 4, 2027	—	Yes	—	—	—
7989589	Dec 4, 2027	—	Yes	—	—	—
9169307	Nov 18, 2027	—	Yes	—		—
9169307	Nov 18, 2027	—	Yes	—		—
10035822	Nov 15, 2033	—	Yes	—	—	—
10125171	Aug 2, 2033	—	Yes	—	—	—
10875893	Nov 15, 2033	—	Yes	—		—
10875893	Nov 15, 2033	—	Yes	—		—
11040107	Apr 9, 2038	—	—	Yes		—
11040107	Apr 9, 2038	—	—	Yes		—
11040107	Apr 9, 2038	—	—	Yes		—
11040107	Apr 9, 2038	—	—	Yes		—
11292815	Nov 15, 2033	—	Yes	Yes		—
11292815	Nov 15, 2033	—	Yes	Yes		—
11292815	Nov 15, 2033	—	Yes	Yes		—
11292815	Nov 15, 2033	—	Yes	Yes		—
11661441	Jan 13, 2033	—	Yes	—		—
11661441	Jan 13, 2033	—	Yes	—		—
11844841	Dec 9, 2038	—	—	Yes		—
11844841	Dec 9, 2038	—	—	Yes		—
11844841	Dec 9, 2038	—	—	Yes		—
11844841	Dec 9, 2038	—	—	Yes		—
12290566	Dec 14, 2038	—	—	Yes		—
12290566	Dec 14, 2038	—	—	Yes		—
12290566	Dec 14, 2038	—	—	Yes		—
12290566	Dec 14, 2038	—	—	Yes		—
12290566	Dec 14, 2038	—	—	Yes		—

Exclusivities (6)

Code	Date	Status
I-972	Jul 28, 2028	Active
M-288	Feb 8, 2026	Expired
NCE	May 14, 2026	Expired
ODE-351	May 14, 2028	Active
ODE-533	Jul 28, 2032	Active
ODE-539	Jul 28, 2032	Active