Application 215244

Type: NDA
Sponsor: STEALTH BIOTHERAPS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FORZINITY	ELAMIPRETIDE HYDROCHLORIDE	SOLUTION;SUBCUTANEOUS	EQ 280MG BASE/3.5ML (EQ 80MG BASE/ML)	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
N215244-001	FORZINITY	ELAMIPRETIDE HYDROCHLORIDE	EQ 280MG BASE/3.5ML (EQ 80MG BASE/ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2025-09-19

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N215244-001	7576061	2027-01-20		Drug substance, Drug product	2025-10-14
N215244-001	11083771	2034-02-28	U-4277		2025-10-14
N215244-001	11083772	2034-02-28	U-4277		2025-10-14
N215244-001	11771734	2034-02-28	U-4277		2025-10-14
N215244-001	12268724	2034-02-28	U-4277		2025-10-14
N215244-001	9687519	2034-02-28	U-4277		2025-10-14

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N215244-001	NCE	2030-09-19
N215244-001	ODE-551	2032-09-19

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	N215244-001	FORZINITY	EQ 280MG BASE/3.5ML (EQ 80MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2025-09-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N215244-001	FORZINITY	EQ 280MG BASE/3.5ML (EQ 80MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2025-09-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N215244-001	FORZINITY	EQ 280MG BASE/3.5ML (EQ 80MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2025-09-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215244-001	FORZINITY	EQ 280MG BASE/3.5ML (EQ 80MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2025-09-19	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215244-001	FORZINITY	EQ 280MG BASE/3.5ML (EQ 80MG BASE/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2025-09-19	`a50c72e98297…`

Observed Orange Book patent history#

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	N215244-001	7576061	2027-01-20		Drug substance, Drug product	2025-10-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215244-001	11083771	2034-02-28	U-4277		2025-10-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215244-001	11083772	2034-02-28	U-4277		2025-10-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215244-001	11771734	2034-02-28	U-4277		2025-10-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215244-001	12268724	2034-02-28	U-4277		2025-10-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215244-001	9687519	2034-02-28	U-4277		2025-10-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N215244-001	7576061	2027-01-20		Drug substance, Drug product	2025-10-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215244-001	11083771	2034-02-28	U-4277		2025-10-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215244-001	11083772	2034-02-28	U-4277		2025-10-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215244-001	11771734	2034-02-28	U-4277		2025-10-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215244-001	12268724	2034-02-28	U-4277		2025-10-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215244-001	9687519	2034-02-28	U-4277		2025-10-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N215244-001	7576061	2027-01-20		Drug substance, Drug product	2025-10-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215244-001	11083771	2034-02-28	U-4277		2025-10-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215244-001	11083772	2034-02-28	U-4277		2025-10-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215244-001	11771734	2034-02-28	U-4277		2025-10-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215244-001	12268724	2034-02-28	U-4277		2025-10-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215244-001	9687519	2034-02-28	U-4277		2025-10-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215244-001	7576061	2026-01-20		Drug substance, Drug product	2025-10-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215244-001	11083771	2034-02-28	U-4277		2025-10-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215244-001	11083772	2034-02-28	U-4277		2025-10-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215244-001	11771734	2034-02-28	U-4277		2025-10-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215244-001	12268724	2034-02-28	U-4277		2025-10-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215244-001	9687519	2034-02-28	U-4277		2025-10-14	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215244-001	7576061	2027-01-20		Drug substance, Drug product	2025-10-14	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215244-001	11083771	2034-02-28	U-4277		2025-10-14	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215244-001	11083772	2034-02-28	U-4277		2025-10-14	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215244-001	11771734	2034-02-28	U-4277		2025-10-14	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215244-001	12268724	2034-02-28	U-4277		2025-10-14	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215244-001	9687519	2034-02-28	U-4277		2025-10-14	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N215244-001	NCE	2030-09-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215244-001	ODE-551	2032-09-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N215244-001	NCE	2030-09-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215244-001	ODE-551	2032-09-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N215244-001	NCE	2030-09-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215244-001	NCE	2030-09-19	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215244-001	NCE	2030-09-19	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215244-001	ODE-551	2032-09-19	`a50c72e98297…`

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
FORZINITY	ELAMIPRETIDE HYDROCHLORIDE	Stealth Biotherapeutics Inc.	146bf34c-76f2-48db-ac07-fb29cce2cd75	2025-12-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 215244 application number: NDA215244

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
83630	ORIG	2025-10-02
83415	ORIG	2025-09-23
83406	ORIG	2025-09-19