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FORZINITY

NDA

ELAMIPRETIDE HYDROCHLORIDE | N215244 | STEALTH BIOTHERAPEUTICS INC

1 strength6 unique patents2 unique exclusivities

Patent Timeline

6 unique patents, 2 exclusivities by expiration date

Expiring < 1yr (1)Active (5)TodayExclusivity

2027

2028

2029

2030

2031

2032

2033

2034

Today

Jan. 20, 2027

Feb. 28, 2034

Feb. 28, 2034

Feb. 28, 2034

Feb. 28, 2034

Feb. 28, 2034

NCE

Sep. 19, 2030

ODE-551

Sep. 19, 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

No clinical trials found on ClinicalTrials.gov for this drug

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Sep 23, 2025	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 280MG BASE/3.5ML (EQ 80MG BASE/ML)

RLD

6 patents2 exclusivities▴

SOLUTION;SUBCUTANEOUS | Approved: Sep 19, 2025

Patents (6)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7576061	Jan 20, 2027	—	Yes	Yes	—	—
9687519	Feb 28, 2034	—	—	—		—
11083771	Feb 28, 2034	—	—	—		—
11083772	Feb 28, 2034	—	—	—		—
11771734	Feb 28, 2034	—	—	—		—
12268724	Feb 28, 2034	—	—	—		—

Exclusivities (2)

Code	Date	Status
NCE	Sep 19, 2030	Active
ODE-551	Sep 19, 2032	Active

Change History (1)

Recent changes detected for this application.

ADDED7/1/2026

Stealth BioTherapeutics' Forzinity (elamipretide hydrochloride) received orphan drug exclusivity designation for application NDA 215244.

New: New record