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Details for Generic Name: rivastigmine

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Rivastigmine is the generic ingredient in two branded drugs marketed by Novartis, Alembic Pharms Ltd, Apotex Inc, Dr Reddys Labs Inc, Macleods Pharms Ltd, Orchid Hlthcare, Sun Pharm Inds, and Watson Labs, and is included in ten NDAs. There are two patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has thirty-two patent family members in twenty-six countries.

There are twenty-nine drug master file entries for rivastigmine. Three suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: rivastigmine

Tradenames:2
Patents:2
Applicants:8
NDAs:10
Drug Master File Entries: see list29
Suppliers / Packaging: see list6
Therapeutic Class:Antidementia Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: rivastigmine

Tentative approvals for RIVASTIGMINE

Applicant Application No. Form Dosage
<disabled><disabled>SOLUTION; ORAL2MG/ML

Clinical Trials for: rivastigmine

Rivastigmine and Huperzine A as Treatments for Cocaine Dependence
Status: Completed Condition: Cocaine Dependence; Cocaine Addiction; Cocaine Abuse; Substance Abuse

Rivastigmine as a Treatment for Methamphetamine Dependence
Status: Completed Condition: Methamphetamine Dependence; Substance Abuse; Methamphetamine Abuse

Effects of Rivastigmine Patch on Activities of Daily Living and Cognition in Patients With Severe Dementia of the Alzheimer's Type (ACTION) (Study Protocol CENA713DUS44, NCT00948766) and a 24 Week Open-label Extension to Study CENA713DUS44
Status: Completed Condition: Alzheimer's Disease

Effects of Exercise and Rivastigmine on Quality of Life of Alzheimer's Disease Patients
Status: Completed Condition: Alzheimer Disease

Long-term Safety of Rivastigmine Capsule and Patch in Patients With Mild to Moderately-severe Dementia Associated With Parkinson's Disease (PDD)
Status: Completed Condition: Parkinson's Disease Dementia

A Double-Blind, Placebo-controlled Crossover Study of Repeat Rivastigmine Administration in Healthy Male Volunteers
Status: Completed Condition: Rivastigmine Toxicity

Courtesy of ClinicalTrials.org
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
Alembic Pharms Ltd
RIVASTIGMINE TARTRATE
rivastigmine tartrate
CAPSULE;ORAL091689-003Jun 12, 2012RXNo<disabled><disabled>
Orchid Hlthcare
RIVASTIGMINE TARTRATE
rivastigmine tartrate
CAPSULE;ORAL090879-003Jun 10, 2015RXNo<disabled><disabled>
Orchid Hlthcare
RIVASTIGMINE TARTRATE
rivastigmine tartrate
CAPSULE;ORAL090879-004Jun 10, 2015RXNo<disabled><disabled>
Watson Labs
RIVASTIGMINE TARTRATE
rivastigmine tartrate
CAPSULE;ORAL077129-001Jan 8, 2008RXNo<disabled><disabled>
Alembic Pharms Ltd
RIVASTIGMINE TARTRATE
rivastigmine tartrate
CAPSULE;ORAL091689-001Jun 12, 2012RXNo<disabled><disabled>
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International Patent Family for Ingredient: rivastigmine

Country Document Number Publication Date
Poland341347Apr 09, 2001
Russian Federation2219926Dec 27, 2003
Norway20003472Aug 07, 2000
Hungary0004300May 28, 2001
Israel137100Dec 15, 2004
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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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