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Last Updated: December 3, 2022

Rivastigmine - Generic Drug Details


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What are the generic sources for rivastigmine and what is the scope of patent protection?

Rivastigmine is the generic ingredient in three branded drugs marketed by Novartis, Alvogen, Amneal Pharms, Breckenridge, Mylan Technologies, Zydus Pharms, Alembic Pharms Ltd, Apotex Inc, Aurobindo Pharma, Cadila Pharms Ltd, Chartwell Rx, Dr Reddys Labs Inc, Macleods Pharms Ltd, Orbion Pharms, Sun Pharm, and Watson Labs, and is included in eighteen NDAs. Additional information is available in the individual branded drug profile pages.

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

Drug Prices for rivastigmine

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Recent Clinical Trials for rivastigmine

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SponsorPhase
Shahid Sadoughi University of Medical Sciences and Health ServicesPhase 3
National Institute for Medical Research Development (NIMAD), IranPhase 3
McMaster UniversityPhase 3

See all rivastigmine clinical trials

Generic filers with tentative approvals for RIVASTIGMINE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing2MG/MLSOLUTION; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for rivastigmine
Medical Subject Heading (MeSH) Categories for rivastigmine
Paragraph IV (Patent) Challenges for RIVASTIGMINE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
EXELON Transdermal System Extended-release rivastigmine 13.3 mg/24 hr 022083 1 2013-01-22
EXELON Transdermal System Extended-release rivastigmine 4.6 mg/24 hr and 9.5 mg/24 hr 022083 1 2011-04-27

US Patents and Regulatory Information for rivastigmine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Watson Labs RIVASTIGMINE TARTRATE rivastigmine tartrate CAPSULE;ORAL 077129-001 Jan 8, 2008 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Apotex Inc RIVASTIGMINE TARTRATE rivastigmine tartrate CAPSULE;ORAL 091072-002 May 16, 2013 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sun Pharm RIVASTIGMINE TARTRATE rivastigmine tartrate CAPSULE;ORAL 077131-002 Oct 22, 2007 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for rivastigmine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis EXELON rivastigmine FILM, EXTENDED RELEASE;TRANSDERMAL 022083-005 Aug 31, 2012 See Plans and Pricing See Plans and Pricing
Novartis EXELON rivastigmine FILM, EXTENDED RELEASE;TRANSDERMAL 022083-002 Jul 6, 2007 See Plans and Pricing See Plans and Pricing
Novartis EXELON rivastigmine FILM, EXTENDED RELEASE;TRANSDERMAL 022083-002 Jul 6, 2007 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for rivastigmine

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Actavis Group PTC ehf Rivastigmine Actavis rivastigmine EMEA/H/C/002036
Symptomatic treatment of mild to moderately severe Alzheimer's dementia.Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson's disease.
Authorised yes no no 2011-06-16
Krka, d.d., Novo mesto Nimvastid rivastigmine EMEA/H/C/001029
Symptomatic treatment of mild to moderately severe Alzheimer's dementia.Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson's disease.
Authorised yes no no 2009-05-11
1 A Pharma GmbH Rivastigmine 1 A Pharma rivastigmine EMEA/H/C/001181
Symptomatic treatment of mild to moderately severe Alzheimer's dementia.Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson's disease.
Authorised no no no 2009-12-11
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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