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Details for Generic Name: rivastigmine

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Rivastigmine is the generic ingredient in three branded drugs marketed by Novartis, Alvogen Pine Brook, Alembic Pharms Ltd, Apotex Inc, Dr Reddys Labs Inc, Macleods Pharms Ltd, Orchid Hlthcare, Sun Pharm Inds, and Watson Labs, and is included in eleven 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 thirty 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

Drug Master File Entries: see list30
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
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
Orchid Hlthcare
rivastigmine tartrate
CAPSULE;ORAL090879-002Jun 10, 2015RXNo<disabled><disabled>
rivastigmine tartrate
CAPSULE;ORAL020823-004Apr 21, 2000RXNo<disabled><disabled>
Apotex Inc
rivastigmine tartrate
CAPSULE;ORAL091072-004May 16, 2013RXNo<disabled><disabled>
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International Patent Family for Ingredient: rivastigmine

Country Document Number Publication Date
New Zealand505650Oct 25, 2002
Slovakia284622Aug 04, 2005
Czech Republic300598Jun 24, 2009
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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.

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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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