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EPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE

NDA

EPINEPHRINE BITARTRATE | N218475 | BAXTER HEALTHCARE CORP

2 strengths0 unique patents0 unique exclusivities

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

2 cases on OB patents (1 active) from PACER

Case	Court	Filed	Status	Judge
PH Health Limited et al v. Baxter Healthcare Corporation 1:2025cv00861 5 patentsepinephrine	D. Del.	2025-07-10	Active	—
Endo USA, Inc. et al v. Baxter Healthcare Corporation 1:2025cv02365 3 patentsepinephrine	N.D. Ill.	2025-03-05	Terminated 2025-06-12	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain3 active DMFs

3 active API suppliers hold Drug Master Files for this ingredient.

CAMBREX PROFARMACO MILANO SRLEPINEPHRINE BITARTRATE

DMF 283852014

MATRIX PHARMACORP PRIVATE LTDEPINEPHRINE BITARTRATE USP

DMF 287502014

ZHEJIANG BOXIAO BIOPHARMACEUTICAL CO LTDEPINEPHRINE BITARTRATE

DMF 425752025

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Oct 3, 2025	SUPPL -1	View Letter (PDF)
Mar 4, 2025	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

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#001 — EQ 16MG BASE/250ML (EQ 64MCG BASE/ML)

RLD

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Feb 28, 2025

No patent or exclusivity listings for this strength.

#002 — EQ 4MG BASE/250ML (EQ 16MCG BASE/ML)

RLD

0 patents0 exclusivities▾

SOLUTION;INTRAVENOUS | Approved: Mar 16, 2026