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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, Sun Pharm Inds, and Watson Labs, and is included in nine 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 are two tentative approvals for this compound.

Summary for Generic Name: rivastigmine

Tradenames:2
Patents:2
Applicants:7
NDAs:9
Drug Master File Entries: see list29
Suppliers: see list3
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
<disabled><disabled>CAPSULE; ORALEQ 1.5MG BASE
<disabled><disabled>CAPSULE; ORALEQ 3MG BASE

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;ORAL091689-001Jun 12, 2012RXNo<disabled><disabled>
Novartis
EXELON
rivastigmine
FILM, EXTENDED RELEASE;TRANSDERMAL022083-005Aug 31, 2012RXNo6,335,031<disabled>Y<disabled>
Sun Pharm Inds
RIVASTIGMINE TARTRATE
rivastigmine tartrate
CAPSULE;ORAL077131-001Oct 22, 2007RXNo<disabled><disabled>
Macleods Pharms Ltd
RIVASTIGMINE TARTRATE
rivastigmine tartrate
CAPSULE;ORAL203148-004Aug 22, 2014RXNo<disabled><disabled>
Alembic Pharms Ltd
RIVASTIGMINE TARTRATE
rivastigmine tartrate
CAPSULE;ORAL091689-003Jun 12, 2012RXNo<disabled><disabled>
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International Patent Family for Ingredient: rivastigmine

Country Document Number Publication Date
European Patent Office1047409Sep 11, 2002
New Zealand505650Oct 25, 2002
Russian Federation2219926Dec 27, 2003
Norway20003472Jul 05, 2000
Denmark1047409Dec 30, 2002
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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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