Viewing data from:

REGITINE

NDA

PHENTOLAMINE MESYLATE | N008278 | NOVARTIS PHARMACEUTICALS CORP

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

1 trial from ClinicalTrials.gov, 1 active

Trial	Phase	Status	Sponsor	Enrollment	Dates
OPI-NXYDLD-303 Safety and Efficacy of Phentolamine Ophthalmic Solution in Keratorefractive Surgery Participants With Decreased Mesopic Visual Acuity NCT07140783	Phase 3	Active	Ocuphire Pharma, Inc.	200	2025-09-02 → 2026-06

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

API Supply Chain3 active DMFs1 inactive

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

JIANGSU LIANHUAN PHARMACEUTICAL CO LTDPHENTOLAMINE MESYLATE

DMF 395782024

APICORE LLC (A WHOLLY OWNED SUB OF RK PHARMA INC)PHENTOLAMINE MESYLATE USP

DMF 399482024

MATRIX PHARMACORP PRIVATE LTDPHENTOLAMINE MESYLATE USP (PROCESS II)

DMF 421122025

SYNKEM DIV PLASTO SAInactivePHENTOLAMINE MESYLATE

DMF 119361996

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

Products (1)

#003 — 5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.