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MEDIHALER-EPI

NDA

EPINEPHRINE BITARTRATE | N010374 | 3M PHARMACEUTICALS INC

1 strength0 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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

3 trials from ClinicalTrials.gov — 2 recruiting, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Vasopressor Agents in Pulmonary Hypertension Crisis NCT07667829	N/A	Not Yet Recruiting	China National Center for Cardiovascular Diseases	75	2026-06 → 2029-01-31
Randomized Trial of UI-EWD vs. Conventional Endoscopic Therapy for Nonvariceal Upper Gastrointestinal Bleeding NCT06188585	N/A	Recruiting	Medtronic - MITG	278	2024-06-21 → 2029-09
DEpth of EPinephrine Delivery With Auto-injectors Devices NCT02886468	N/A	Completed	Centre Hospitalier Régional Metz-Thionville	107	2016-08-26 → 2021-08-16

Source: ClinicalTrials.gov. Trials matched by ingredient name.

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.

Products (1)

#003 — 0.3MG/INH

0 patents0 exclusivities▴

AEROSOL, METERED;INHALATION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.