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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

Evaluation of Adhesion and Dermal Tolerability of EMSAM
Status: Completed Condition: Healthy

PK Comparison of 6mg and 12mg EMSAM in Elderly vs. Non-Elderly
Status: Completed Condition: Healthy

Tolerability and Efficacy of Switch From Oral Selegiline to Orally Disintegrating Selegiline (Zelapar) in Patients With Parkinson's Disease
Status: Completed Condition: Parkinson's Disease

Phase IV:Safety and Efficacy of EMSAM in Adolescents With Major Depression
Status: Completed Condition: Major Depressive Disorder

A Pilot Study Assessing EmSam in Bipolar Depression
Status: Terminated Condition: Bipolar Depression

A Study of Thioctic Acid and Deprenyl in HIV-Infected Patients With Dementia
Status: Completed Condition: Cognitive Disorders; HIV Infections

Effectiveness of Selegiline in Treating Marijuana Dependent Individuals - 1
Status: Completed Condition: Marijuana Abuse

Efficacy of Orally Disintegrating Selegiline in Parkinson's Patients Experiencing Adverse Effects With Dopamine Agonists
Status: Completed Condition: Parkinson's Disease

A Study of RO4602522 in Patients With Alzheimer Disease and in Healthy Volunteers
Status: Completed Condition: Alzheimer Disease, Healthy Volunteer

Safety and Effectiveness of the Selegiline "Patch" for Decreased Mental Function in HIV Patients
Status: Completed Condition: Cognition Disorders; HIV Infections

A Study of Decreased Mental Function Associated With HIV
Status: Completed Condition: Cognitive Disorders; HIV Infections

Role of Preoperative Carbohydrates Drinks, Dichloroacetate and Exercise on Postoperative Muscle Insulin Resistance
Status: Recruiting Condition: Insulin Resistance

Impact of Physical Activity on Blood Glucose Stability and Energy Stores in Individuals With Type 1 Diabetes
Status: Enrolling by invitation Condition: Type 1 Diabetes Mellitus; Exercise; Hypoglycemia; Carbohydrate Metabolism

Sagene 2014 - Parkinson's Disease and Erectile Dysfunction
Status: Recruiting Condition: Parkinson's Disease; Erectile Dysfunction

Clinical Research Study to Evaluate Selegiline in the Treatment of Borderline Personality Disorder
Status: Completed Condition: Borderline Personality Disorder

Combined Donepezil and Selegiline Effects on Cocaine-Reinforced Behavior
Status: Completed Condition: Cocaine Use Disorders

Selegiline Patch for Treatment of Nicotine Dependence
Status: Completed Condition: Tobacco Use Disorder

Usefulness of Selegiline as an Aid to Quit Smoking - 1
Status: Completed Condition: Tobacco Use Cessation

Pioglitazone in Early Parkinson's Disease
Status: Completed Condition: Parkinson's Disease

Courtesy of
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
selegiline hydrochloride
TABLET;ORAL019334-001Jun 5, 1989DISCNNo<disabled><disabled>
Vintage Pharms Llc
selegiline hydrochloride
TABLET;ORAL074565-001Aug 2, 1996DISCNNo<disabled><disabled>
Valeant Pharm Intl
selegiline hydrochloride
TABLET, ORALLY DISINTEGRATING;ORAL021479-001Jun 14, 2006RXYes6,423,342<disabled>Y <disabled>
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International Patent Family for Ingredient: selegiline hydrochloride

Country Document Number Publication Date
European Patent Office0642334Aug 18, 1999
Spain2160232Nov 01, 2001
Germany69326063Mar 16, 2000
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Preferred citation:

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

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