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SELEGILINE HYDROCHLORIDE

NDA

SELEGILINE HYDROCHLORIDE | N019334 | QUAGEN PHARMACEUTICALS LLC

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 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study to Assess the Bioavailability and Adhesion of Selegiline TDS in Healthy Subjects NCT07571824	Phase 1	Completed	Corium Innovations, Inc.	92	2026-03-23 → 2026-06-16

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

API Supply Chain3 active DMFs8 inactive

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

EUROAPI HUNGARY LTDSELEGILINE HYDROCHLORIDE

DMF 51611983

DIPHARMA FRANCIS SRLSELEGILINE HYDROCHLORIDE

DMF 92751991

CATALENT UK SWINDON ZYDIS LTDSELEGILINE HYDROCHLORIDE ZYDIS TABLET 1.25MG

DMF 159142002

WYCKOFF CHEMICAL CO INCInactiveSELEGILINE HYDROCHLORIDE

DMF 92301991

ALCHYMARS SPAInactiveSELEGILINE HYDROCHLORIDE

DMF 97341992

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveSELEGILINE HYDROCHLORIDE

DMF 102351993

SIEGFRIED PHARMACHEMIKALIEN MINDEN GMBHInactiveSELEGILINE HYDROCHLORIDE

DMF 103401993

IROTEC LABORATORIESInactiveSELEGILINE HYDROCHLORIDE

DMF 105291993

SIEGFRIED LTDInactiveSELEGILINE HYDROCHLORIDE

DMF 111041994

RESOLUTION CHEMICALS LTDInactiveSELEGILINE HYDROCHLORIDE

DMF 113561995

FARMAK ASInactiveSELEGILINE HYDROCHLORIDE USP

DMF 310242016

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Jan 6, 2009	SUPPL -19	View Letter (PDF)
Jan 6, 2009	SUPPL -20	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jun 5, 1989

No patent or exclusivity listings for this strength.