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Selegiline - Generic Drug Details

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Selegiline is the generic ingredient in four branded drugs marketed by Somerset, Stason, Apotex, 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 sixteen NDAs. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has three patent family members in two countries.

There are fifteen drug master file entries for selegiline. One supplier is listed for this compound.

Summary for Generic Name: selegiline

Tradenames:4
Patents:4
Applicants:11
NDAs:16
Drug Master File Entries: see list15
Suppliers / Packaging: see list1
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details
Drug Prices:see low prices
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
G And W Labs Inc
SELEGILINE HYDROCHLORIDE
selegiline hydrochloride
TABLET;ORAL074744-001Jan 27, 1997DISCNNo► subscribe► subscribe
Mylan
SELEGILINE HYDROCHLORIDE
selegiline hydrochloride
TABLET;ORAL074866-001Nov 26, 1997RXNo► subscribe► subscribe
Somerset
EMSAM
selegiline
FILM, EXTENDED RELEASE;TRANSDERMAL021336-003Feb 27, 2006RXNo7,070,808► subscribeYY ► subscribe
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Expired Orange Book Patents for Generic Ingredient: selegiline

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Somerset
EMSAM
selegiline
FILM, EXTENDED RELEASE;TRANSDERMAL021336-001Feb 27, 2006RE34579► subscribe
Somerset
EMSAM
selegiline
FILM, EXTENDED RELEASE;TRANSDERMAL021336-003Feb 27, 2006RE34579► subscribe
Somerset
EMSAM
selegiline
FILM, EXTENDED RELEASE;TRANSDERMAL021336-002Feb 27, 2006RE34579► subscribe
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Non-Orange Book Patents for Generic Ingredient: selegiline

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,846,093Adhesive mixture for transdermal delivery of highly plasticizing drugs► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: selegiline

Country Document Number Estimated Expiration
European Patent Office1561461► subscribe
JapanH1160475► subscribe
European Patent Office0887075► subscribe
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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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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