SELEGILINE HYDROCHLORIDE - Generic Drug Details

What are the generic drug sources for selegiline hydrochloride and what is the scope of freedom to operate?

Selegiline hydrochloride is the generic ingredient in three branded drugs marketed by Norvium Bioscience, Apotex, Lannett Co Inc, Novitium Pharma, Rising, Bausch, Apotex Inc, Chartwell Molecules, Cosette, Dash Pharms Natco, G And W Labs Inc, I3 Pharms, and Kenton, and is included in sixteen NDAs. Additional information is available in the individual branded drug profile pages.

There are twelve drug master file entries for selegiline hydrochloride. Eleven suppliers are listed for this compound.

Summary for SELEGILINE HYDROCHLORIDE

US Patents:	0
Tradenames:	3
Applicants:	13
NDAs:	16
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	11
Raw Ingredient (Bulk) Api Vendors:	67
Clinical Trials:	38
Patent Applications:	969
What excipients (inactive ingredients) are in SELEGILINE HYDROCHLORIDE?	SELEGILINE HYDROCHLORIDE excipients list
DailyMed Link:	SELEGILINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for SELEGILINE HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Ibadan	Phase 1/Phase 2
E-Group ICT Software Informatikai Zrt.	Phase 2
László Mangel	Phase 2

See all SELEGILINE HYDROCHLORIDE clinical trials

Pharmacology for SELEGILINE HYDROCHLORIDE

Drug Class	Monoamine Oxidase Inhibitor Monoamine Oxidase Type B Inhibitor
Mechanism of Action	Monoamine Oxidase Inhibitors Monoamine Oxidase-B Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for SELEGILINE HYDROCHLORIDE

N04BD	Monoamine oxidase B inhibitors
N04B	DOPAMINERGIC AGENTS
N04	ANTI-PARKINSON DRUGS
N	Nervous system

US Patents and Regulatory Information for SELEGILINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
I3 Pharms	SELEGILINE HYDROCHLORIDE	selegiline hydrochloride	TABLET;ORAL	074672-001	Apr 1, 1997	AB	RX	No	No
Norvium Bioscience	SELEGILINE HYDROCHLORIDE	selegiline hydrochloride	TABLET;ORAL	019334-001	Jun 5, 1989		DISCN	Yes	No
Chartwell Molecules	SELEGILINE HYDROCHLORIDE	selegiline hydrochloride	TABLET;ORAL	074641-001	Aug 2, 1996		DISCN	No	No
Cosette	SELEGILINE HYDROCHLORIDE	selegiline hydrochloride	TABLET;ORAL	074756-001	Nov 25, 1998		DISCN	No	No
G And W Labs Inc	SELEGILINE HYDROCHLORIDE	selegiline hydrochloride	TABLET;ORAL	074537-001	Aug 2, 1996		DISCN	No	No
Chartwell Molecules	SELEGILINE HYDROCHLORIDE	selegiline hydrochloride	TABLET;ORAL	074565-001	Aug 2, 1996		DISCN	No	No
Apotex	SELEGILINE HYDROCHLORIDE	selegiline hydrochloride	CAPSULE;ORAL	075321-001	Dec 4, 1998	AB	RX	No	Yes

Expired US Patents for SELEGILINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	ZELAPAR	selegiline hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	021479-001	Jun 14, 2006
Bausch	ZELAPAR	selegiline hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	021479-001	Jun 14, 2006