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Selegiline hydrochloride - Generic Drug Details

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

This ingredient has twelve patent family members in twelve countries.

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

Summary for Generic Name: selegiline hydrochloride

Tradenames:3
Patents:1
Applicants:11
NDAs:15
Drug Master File Entries: see list15
Suppliers / Packaging: see list10
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
ZELAPAR
selegiline hydrochloride
TABLET, ORALLY DISINTEGRATING;ORAL021479-001Jun 14, 2006RXYes6,423,342<disabled>Y <disabled>
Apotex
SELEGILINE HYDROCHLORIDE
selegiline hydrochloride
CAPSULE;ORAL075321-001Dec 4, 1998RXNo<disabled><disabled>
Lannett Holdings Inc
SELEGILINE HYDROCHLORIDE
selegiline hydrochloride
CAPSULE;ORAL075145-001Sep 15, 2003DISCNNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: selegiline hydrochloride

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant Pharm Intl
ZELAPAR
selegiline hydrochloride
TABLET, ORALLY DISINTEGRATING;ORAL021479-001Jun 14, 20065,648,093<disabled>
Valeant Pharm Intl
ZELAPAR
selegiline hydrochloride
TABLET, ORALLY DISINTEGRATING;ORAL021479-001Jun 14, 20066,423,342<disabled>
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International Patent Family for Ingredient: selegiline hydrochloride

Country Document Number Estimated Expiration
South Africa9601734<disabled in preview>
Spain2160232<disabled in preview>
JapanH10506408<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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