Is Apellis Pharmaceuticals, Inc. FDA approved?

Apellis Pharmaceuticals, Inc. holds no registered establishment of its own; 2 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does Apellis Pharmaceuticals, Inc. make?

2 products are listed under Apellis Pharmaceuticals, Inc. in the openFDA NDC Directory, most often as injection, solution. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Apellis Pharmaceuticals, Inc.

Data as of 24 Sept 2026 · How to read this entry

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Registered sites: 0
Active NDC listings: 2
Live patents: 24
Exclusivities: 1
Countries: 0

Catalogue

Drug listings by form and route

2 active NDC listings: 2 human prescription drug. By marketing category: NDA 2.

Dosage form	NDCs
injection, solution	2

Route	NDCs
intravitreal	1
subcutaneous	1

Labeller name on the listing	NDCs
apellis pharmaceuticals, inc.	2

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
9056076	SYFOVREpegcetacoplan	use	Oct 2026
8168584	SYFOVREpegcetacoplan	use	Apr 2027
9169307	EMPAVELI, SYFOVREpegcetacoplan	substance	Nov 2027
7888323	EMPAVELI, SYFOVREpegcetacoplan	substance	Dec 2027
7989589	EMPAVELI, SYFOVREpegcetacoplan	substance	Dec 2027
11661441	EMPAVELI, SYFOVREpegcetacoplan	substance	Jan 2033
10125171	EMPAVELI, SYFOVREpegcetacoplan	substance	Aug 2033
10035822	EMPAVELI, SYFOVREpegcetacoplan	substance	Nov 2033
10875893	EMPAVELI, SYFOVREpegcetacoplan	substance	Nov 2033
11292815	EMPAVELI, SYFOVREpegcetacoplan	substance, product	Nov 2033
12528836	SYFOVREpegcetacoplan	use	Oct 2036
11903994	SYFOVREpegcetacoplan	use	Feb 2037
11040107	EMPAVELIpegcetacoplan	product	Apr 2038
11844841	EMPAVELIpegcetacoplan	product	Dec 2038
12290566	EMPAVELIpegcetacoplan	product	Dec 2038
12458695	SYFOVREpegcetacoplan	product	Dec 2038

Product	Exclusivity	Until
EMPAVELIPEGCETACOPLAN	ODE-533 Orphan drug	Jul 2032

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Empaveli	Pegcetacoplan	injection, solution, subcutaneous	73606-010NDA
Syfovre	Pegcetacoplan	injection, solution, intravitreal	73606-020NDA

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Common questions

Is Apellis Pharmaceuticals, Inc. FDA approved?: Apellis Pharmaceuticals, Inc. holds no registered establishment of its own; 2 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does Apellis Pharmaceuticals, Inc. make?: 2 products are listed under Apellis Pharmaceuticals, Inc. in the openFDA NDC Directory, most often as injection, solution. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.