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Details for Generic Name: rivastigmine tartrate

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Rivastigmine tartrate 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 nine NDAs. Additional information is available in the individual branded drug profile pages.

There are thirty-two drug master file entries for rivastigmine tartrate. Three suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: rivastigmine tartrate

Tradenames:2
Patents:0
Applicants:8
NDAs:9
Drug Master File Entries: see list32
Suppliers / Packaging: see list25
Therapeutic Class:Antidementia Agents

Pharmacology for Ingredient: rivastigmine tartrate

Tentative approvals for RIVASTIGMINE TARTRATE

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

Clinical Trials for: rivastigmine tartrate

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

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

A 24-Week Efficacy, Safety and Tolerability of Rivastigmine Patch Study in Patients With Probable Alzheimer's Disease
Status: Completed Condition: Alzheimer's Disease

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
Apotex Inc
RIVASTIGMINE TARTRATE
rivastigmine tartrate
CAPSULE;ORAL091072-002May 16, 2013RXNo<disabled><disabled>
Macleods Pharms Ltd
RIVASTIGMINE TARTRATE
rivastigmine tartrate
CAPSULE;ORAL203148-001Aug 22, 2014RXNo<disabled><disabled>
Dr Reddys Labs Inc
RIVASTIGMINE TARTRATE
rivastigmine tartrate
CAPSULE;ORAL077130-002Oct 31, 2007RXNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: rivastigmine tartrate

These historical archives are available as an add-on to one-year subscriptions

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
EXELON
rivastigmine tartrate
CAPSULE;ORAL020823-003Apr 21, 20004,948,807<disabled>
Novartis
EXELON
rivastigmine tartrate
CAPSULE;ORAL020823-006Apr 21, 20005,602,176<disabled>
Novartis
EXELON
rivastigmine tartrate
CAPSULE;ORAL020823-006Apr 21, 20004,948,807<disabled>
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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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