Application 217171

Type: NDA
Sponsor: APELLIS PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SYFOVRE	PEGCETACOPLAN	SOLUTION;INTRAVITREAL	15MG/0.1ML (15MG/0.1ML)	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N217171-001	SYFOVRE	PEGCETACOPLAN	15MG/0.1ML (15MG/0.1ML)	SOLUTION / INTRAVITREAL		RLD, RS	2023-02-17

Orange Book patents#

Current patent rows page 1 of 1 · 16 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N217171-001	9056076	2026-10-25	U-3540		2023-03-09
N217171-001	8168584	2027-04-07	U-3540		2023-03-09
N217171-001	8168584	2027-04-07	U-3542		2023-03-09
N217171-001	9169307	2027-11-18	U-3541	Drug substance	2023-03-09
N217171-001	7888323	2027-12-04		Drug substance	2023-03-09
N217171-001	7989589	2027-12-04		Drug substance	2023-03-09
N217171-001	11661441	2033-01-13	U-3540	Drug substance	2023-06-26
N217171-001	10125171	2033-08-02		Drug substance	2023-03-09
N217171-001	10035822	2033-11-15		Drug substance	2023-03-09
N217171-001	10875893	2033-11-15	U-3540	Drug substance	2023-03-09
N217171-001	11292815	2033-11-15	U-3540	Drug substance, Drug product	2023-03-09
N217171-001	12528836	2036-10-07	U-4394		2026-01-23
N217171-001	11903994	2037-02-22	U-3826		2024-03-18
N217171-001	11903994	2037-02-22	U-3827		2024-03-18
N217171-001	11903994	2037-02-22	U-3828		2024-03-18
N217171-001	12458695	2038-12-14		Drug product	2025-11-07

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N217171-001	NP	2026-02-22
N217171-001	NCE	2026-05-14

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N217171-001	SYFOVRE	15MG/0.1ML (15MG/0.1ML)	SOLUTION / INTRAVITREAL	RLD, RS	2023-02-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N217171-001	SYFOVRE	15MG/0.1ML (15MG/0.1ML)	SOLUTION / INTRAVITREAL	RLD, RS	2023-02-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N217171-001	SYFOVRE	15MG/0.1ML (15MG/0.1ML)	SOLUTION / INTRAVITREAL	RLD, RS	2023-02-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217171-001	SYFOVRE	15MG/0.1ML (15MG/0.1ML)	SOLUTION / INTRAVITREAL	RLD, RS	2023-02-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217171-001	SYFOVRE	15MG/0.1ML (15MG/0.1ML)	SOLUTION / INTRAVITREAL	RLD, RS	2023-02-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217171-001	SYFOVRE	15MG/0.1ML (15MG/0.1ML)	SOLUTION / INTRAVITREAL	RLD, RS	2023-02-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217171-001	SYFOVRE	15MG/0.1ML (15MG/0.1ML)	SOLUTION / INTRAVITREAL	RLD, RS	2023-02-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217171-001	SYFOVRE	15MG/0.1ML (15MG/0.1ML)	SOLUTION / INTRAVITREAL	RLD, RS	2023-02-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217171-001	SYFOVRE	15MG/0.1ML (15MG/0.1ML)	SOLUTION / INTRAVITREAL	RLD, RS	2023-02-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217171-001	SYFOVRE	15MG/0.1ML (15MG/0.1ML)	SOLUTION / INTRAVITREAL	RLD, RS	2023-02-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217171-001	SYFOVRE	15MG/0.1ML (15MG/0.1ML)	SOLUTION / INTRAVITREAL	RLD, RS	2023-02-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N217171-001	SYFOVRE	15MG/0.1ML (15MG/0.1ML)	SOLUTION / INTRAVITREAL	RLD, RS	2023-02-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217171-001	SYFOVRE	15MG/0.1ML (15MG/0.1ML)	SOLUTION / INTRAVITREAL	RLD, RS	2023-02-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217171-001	SYFOVRE	15MG/0.1ML (15MG/0.1ML)	SOLUTION / INTRAVITREAL	RLD, RS	2023-02-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N217171-001	SYFOVRE	15MG/0.1ML (15MG/0.1ML)	SOLUTION / INTRAVITREAL	RLD, RS	2023-02-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N217171-001	SYFOVRE	15MG/0.1ML (15MG/0.1ML)	SOLUTION / INTRAVITREAL	RLD, RS	2023-02-17	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N217171-001	SYFOVRE	15MG/0.1ML (15MG/0.1ML)	SOLUTION / INTRAVITREAL	RLD, RS	2023-02-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N217171-001	SYFOVRE	15MG/0.1ML (15MG/0.1ML)	SOLUTION / INTRAVITREAL	RLD, RS	2023-02-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N217171-001	SYFOVRE	15MG/0.1ML (15MG/0.1ML)	SOLUTION / INTRAVITREAL	RLD, RS	2023-02-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N217171-001	SYFOVRE	15MG/0.1ML (15MG/0.1ML)	SOLUTION / INTRAVITREAL	RLD, RS	2023-02-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N217171-001	SYFOVRE	15MG/0.1ML (15MG/0.1ML)	SOLUTION / INTRAVITREAL	RLD, RS	2023-02-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N217171-001	SYFOVRE	15MG/0.1ML (15MG/0.1ML)	SOLUTION / INTRAVITREAL	RLD, RS	2023-02-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N217171-001	SYFOVRE	15MG/0.1ML (15MG/0.1ML)	SOLUTION / INTRAVITREAL	RLD, RS	2023-02-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N217171-001	SYFOVRE	15MG/0.1ML (15MG/0.1ML)	SOLUTION / INTRAVITREAL	RLD, RS	2023-02-17	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217171-001	SYFOVRE	15MG/0.1ML (15MG/0.1ML)	SOLUTION / INTRAVITREAL	RLD, RS	2023-02-17	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 9 · 333 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N217171-001	9056076	2026-10-25	U-3540		2023-03-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217171-001	8168584	2027-04-07	U-3540		2023-03-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217171-001	8168584	2027-04-07	U-3542		2023-03-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217171-001	9169307	2027-11-18	U-3541	Drug substance	2023-03-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217171-001	7888323	2027-12-04		Drug substance	2023-03-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217171-001	7989589	2027-12-04		Drug substance	2023-03-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217171-001	11661441	2033-01-13	U-3540	Drug substance	2023-06-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217171-001	10125171	2033-08-02		Drug substance	2023-03-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217171-001	10035822	2033-11-15		Drug substance	2023-03-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217171-001	10875893	2033-11-15	U-3540	Drug substance	2023-03-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217171-001	11292815	2033-11-15	U-3540	Drug substance, Drug product	2023-03-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217171-001	12528836	2036-10-07	U-4394		2026-01-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217171-001	11903994	2037-02-22	U-3826		2024-03-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217171-001	11903994	2037-02-22	U-3827		2024-03-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217171-001	11903994	2037-02-22	U-3828		2024-03-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217171-001	12458695	2038-12-14		Drug product	2025-11-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N217171-001	9056076	2026-10-25	U-3540		2023-03-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217171-001	8168584	2027-04-07	U-3540		2023-03-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217171-001	8168584	2027-04-07	U-3542		2023-03-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217171-001	9169307	2027-11-18	U-3541	Drug substance	2023-03-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217171-001	7888323	2027-12-04		Drug substance	2023-03-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217171-001	7989589	2027-12-04		Drug substance	2023-03-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217171-001	11661441	2033-01-13	U-3540	Drug substance	2023-06-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217171-001	10125171	2033-08-02		Drug substance	2023-03-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217171-001	10035822	2033-11-15		Drug substance	2023-03-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217171-001	10875893	2033-11-15	U-3540	Drug substance	2023-03-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217171-001	11292815	2033-11-15	U-3540	Drug substance, Drug product	2023-03-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217171-001	12528836	2036-10-07	U-4394		2026-01-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217171-001	11903994	2037-02-22	U-3826		2024-03-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217171-001	11903994	2037-02-22	U-3827		2024-03-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217171-001	11903994	2037-02-22	U-3828		2024-03-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217171-001	12458695	2038-12-14		Drug product	2025-11-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N217171-001	9056076	2026-10-25	U-3540		2023-03-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217171-001	8168584	2027-04-07	U-3540		2023-03-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217171-001	8168584	2027-04-07	U-3542		2023-03-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217171-001	9169307	2027-11-18	U-3541	Drug substance	2023-03-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217171-001	7888323	2027-12-04		Drug substance	2023-03-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217171-001	7989589	2027-12-04		Drug substance	2023-03-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217171-001	11661441	2033-01-13	U-3540	Drug substance	2023-06-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217171-001	10125171	2033-08-02		Drug substance	2023-03-09	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 50 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N217171-001	NP	2026-02-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217171-001	NCE	2026-05-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N217171-001	NP	2026-02-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217171-001	NCE	2026-05-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N217171-001	NP	2026-02-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217171-001	NCE	2026-05-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217171-001	NP	2026-02-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217171-001	NCE	2026-05-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217171-001	NP	2026-02-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217171-001	NCE	2026-05-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217171-001	NP	2026-02-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217171-001	NCE	2026-05-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217171-001	NP	2026-02-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217171-001	NCE	2026-05-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217171-001	NP	2026-02-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217171-001	NCE	2026-05-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217171-001	NP	2026-02-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217171-001	NCE	2026-05-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217171-001	NP	2026-02-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217171-001	NCE	2026-05-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217171-001	NP	2026-02-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217171-001	NCE	2026-05-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N217171-001	NP	2026-02-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N217171-001	NCE	2026-05-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217171-001	NP	2026-02-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217171-001	NCE	2026-05-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217171-001	NP	2026-02-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217171-001	NCE	2026-05-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N217171-001	NP	2026-02-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N217171-001	NCE	2026-05-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N217171-001	NP	2026-02-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N217171-001	NCE	2026-05-14	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N217171-001	NP	2026-02-22	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N217171-001	NCE	2026-05-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N217171-001	NP	2026-02-22	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N217171-001	NCE	2026-05-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N217171-001	NP	2026-02-22	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N217171-001	NCE	2026-05-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N217171-001	NP	2026-02-22	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N217171-001	NCE	2026-05-14	`a72a2bbeb626…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Syfovre	PEGCETACOPLAN	Apellis Pharmaceuticals, Inc.	b4434e61-9ec9-4e0e-bd60-45aaa0a87e64	2025-09-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 217171 application number: NDA217171

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84263	SUPPL	2025-11-21
82954	SUPPL	2025-07-28
80712	SUPPL	2024-12-26
80698	SUPPL	2024-12-23
76714	SUPPL	2023-12-01
76706	SUPPL	2023-12-01
73574	ORIG	2023-09-13
74454	ORIG	2023-06-07
73558	ORIG	2023-02-17