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Last Updated: March 28, 2024

Rivastigmine - Generic Drug Details


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What are the generic sources for rivastigmine and what is the scope of freedom to operate?

Rivastigmine is the generic ingredient in three branded drugs marketed by Sandoz, Alvogen, Amneal Pharms, Breckenridge, Mylan Technologies, Zydus Pharms, Novartis, 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. Eleven 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

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Luye Pharma Group Ltd.Phase 1
Tergooi HospitalPhase 4
St. Antonius HospitalPhase 4

See all rivastigmine clinical trials

Generic filers with tentative approvals for RIVASTIGMINE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial2MG/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
Apotex Inc RIVASTIGMINE TARTRATE rivastigmine tartrate CAPSULE;ORAL 091072-004 May 16, 2013 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Alembic Pharms Ltd RIVASTIGMINE TARTRATE rivastigmine tartrate CAPSULE;ORAL 091689-004 Jun 12, 2012 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Orbion Pharms RIVASTIGMINE TARTRATE rivastigmine tartrate CAPSULE;ORAL 090879-002 Jun 10, 2015 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Apotex Inc RIVASTIGMINE TARTRATE rivastigmine tartrate CAPSULE;ORAL 091072-002 May 16, 2013 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novartis EXELON rivastigmine tartrate CAPSULE;ORAL 020823-004 Apr 21, 2000 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Watson Labs RIVASTIGMINE TARTRATE rivastigmine tartrate CAPSULE;ORAL 077129-001 Jan 8, 2008 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Alembic Pharms Ltd RIVASTIGMINE TARTRATE rivastigmine tartrate CAPSULE;ORAL 091689-001 Jun 12, 2012 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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
Sandoz EXELON rivastigmine FILM, EXTENDED RELEASE;TRANSDERMAL 022083-001 Jul 6, 2007 ⤷  Try a Trial ⤷  Try a Trial
Sandoz EXELON rivastigmine FILM, EXTENDED RELEASE;TRANSDERMAL 022083-005 Aug 31, 2012 ⤷  Try a Trial ⤷  Try a Trial
Sandoz EXELON rivastigmine FILM, EXTENDED RELEASE;TRANSDERMAL 022083-002 Jul 6, 2007 ⤷  Try a Trial ⤷  Try a Trial
Sandoz EXELON rivastigmine FILM, EXTENDED RELEASE;TRANSDERMAL 022083-005 Aug 31, 2012 ⤷  Try a Trial ⤷  Try a Trial
Sandoz EXELON rivastigmine FILM, EXTENDED RELEASE;TRANSDERMAL 022083-005 Aug 31, 2012 ⤷  Try a Trial ⤷  Try a Trial
Sandoz EXELON rivastigmine FILM, EXTENDED RELEASE;TRANSDERMAL 022083-002 Jul 6, 2007 ⤷  Try a Trial ⤷  Try a Trial
Sandoz EXELON rivastigmine FILM, EXTENDED RELEASE;TRANSDERMAL 022083-001 Jul 6, 2007 ⤷  Try a Trial ⤷  Try a Trial
>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
Novartis Europharm Limited Exelon rivastigmine EMEA/H/C/000169
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 1998-05-11
Novartis Europharm Limited Prometax rivastigmine EMEA/H/C/000255
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 1998-12-03
Sandoz GmbH Rivastigmine Sandoz rivastigmine EMEA/H/C/001183
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 2009-12-10
Hexal AG  Rivastigmine Hexal rivastigmine EMEA/H/C/001182
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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