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Details for Generic Name: selegiline hydrochloride

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Selegiline hydrochloride is the generic ingredient in three branded drugs marketed by Somerset, Apotex, Dava Pharms Inc, Lannett Holdings Inc, Valeant Pharm Intl, Apotex Inc, G And W Labs Inc, Mylan, Siegfried, Stason, and Vintage Pharms Llc, and is included in fifteen NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has sixty-five patent family members in thirty-three countries.

There are fifteen drug master file entries for selegiline hydrochloride. Two suppliers are listed for this compound.

Summary for Generic Name: selegiline hydrochloride

Drug Master File Entries: see list15
Suppliers / Packaging: see list3
Therapeutic Class:Antiparkinson Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: selegiline hydrochloride

Clinical Trials for: selegiline hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Valeant Pharm Intl
selegiline hydrochloride
TABLET, ORALLY DISINTEGRATING;ORAL021479-001Jun 14, 2006RXYes6,423,342<disabled>Y<disabled>
selegiline hydrochloride
TABLET;ORAL074672-001Apr 1, 1997DISCNNo<disabled><disabled>
G And W Labs Inc
selegiline hydrochloride
TABLET;ORAL074756-001Nov 25, 1998DISCNNo<disabled><disabled>
selegiline hydrochloride
CAPSULE;ORAL020647-001May 15, 1996RXYes<disabled><disabled>
selegiline hydrochloride
TABLET;ORAL019334-001Jun 5, 1989DISCNNo<disabled><disabled>
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International Patent Family for Ingredient: selegiline hydrochloride

Country Document Number Publication Date
Greece3029555Jun 30, 1999
Chile2004001180Jun 03, 2005
United Kingdom9504201Apr 19, 1995
Greece3036516Dec 31, 2001
Spain2160232Nov 01, 2001
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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