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Last Updated: April 14, 2021

DrugPatentWatch Database Preview

Selegiline hydrochloride - Generic Drug Details

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What are the generic sources for selegiline hydrochloride and what is the scope of patent protection?

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

There are seventeen drug master file entries for selegiline hydrochloride. Six suppliers are listed for this compound.

Summary for selegiline hydrochloride
US Patents:0
Tradenames:3
Applicants:13
NDAs:16
Drug Master File Entries: 17
Suppliers / Packagers: 6
Bulk Api Vendors: 53
Clinical Trials: 35
Patent Applications: 906
Formulation / Manufacturing:see details
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

SponsorPhase
E-Group ICT Software Informatikai Zrt.Phase 2
László MangelPhase 2
University of OxfordN/A

See all selegiline hydrochloride clinical trials

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
Somerset SELEGILINE HYDROCHLORIDE selegiline hydrochloride TABLET;ORAL 019334-001 Jun 5, 1989 DISCN Yes No   Start Trial   Start Trial   Start Trial
Bausch ZELAPAR selegiline hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 021479-001 Jun 14, 2006 RX Yes Yes   Start Trial   Start Trial   Start Trial
Mylan SELEGILINE HYDROCHLORIDE selegiline hydrochloride TABLET;ORAL 074866-001 Nov 26, 1997 DISCN No No   Start Trial   Start Trial   Start Trial
Chartwell Molecules SELEGILINE HYDROCHLORIDE selegiline hydrochloride TABLET;ORAL 074565-001 Aug 2, 1996 DISCN No No   Start Trial   Start Trial   Start Trial
G And W Labs Inc SELEGILINE HYDROCHLORIDE selegiline hydrochloride TABLET;ORAL 074537-001 Aug 2, 1996 DISCN No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

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