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Last Updated: November 4, 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

See drug prices for rivastigmine

Recent Clinical Trials for rivastigmine

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

SponsorPhase
NeuroSense Therapeutics Ltd.Phase 2
Luye Pharma Group Ltd.Phase 1
St. Antonius HospitalPhase 4

See all rivastigmine clinical trials

Generic filers with tentative approvals for RIVASTIGMINE
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up2MG/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
Anatomical Therapeutic Chemical (ATC) Classes 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
Cadila Pharms Ltd RIVASTIGMINE TARTRATE rivastigmine tartrate CAPSULE;ORAL 203844-003 Feb 13, 2017 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sun Pharm RIVASTIGMINE TARTRATE rivastigmine tartrate CAPSULE;ORAL 077131-004 Oct 22, 2007 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Macleods Pharms Ltd RIVASTIGMINE TARTRATE rivastigmine tartrate CAPSULE;ORAL 203148-002 Aug 22, 2014 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Alembic Pharms Ltd RIVASTIGMINE TARTRATE rivastigmine tartrate CAPSULE;ORAL 091689-002 Jun 12, 2012 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Novartis EXELON rivastigmine tartrate SOLUTION;ORAL 021025-001 Apr 21, 2000 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Chartwell Rx RIVASTIGMINE TARTRATE rivastigmine tartrate CAPSULE;ORAL 207797-003 Sep 28, 2017 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 022083-005 Aug 31, 2012 ⤷  Sign Up ⤷  Sign Up
Sandoz EXELON rivastigmine FILM, EXTENDED RELEASE;TRANSDERMAL 022083-001 Jul 6, 2007 ⤷  Sign Up ⤷  Sign Up
Sandoz EXELON rivastigmine FILM, EXTENDED RELEASE;TRANSDERMAL 022083-002 Jul 6, 2007 ⤷  Sign Up ⤷  Sign Up
Sandoz EXELON rivastigmine FILM, EXTENDED RELEASE;TRANSDERMAL 022083-005 Aug 31, 2012 ⤷  Sign Up ⤷  Sign Up
Sandoz EXELON rivastigmine FILM, EXTENDED RELEASE;TRANSDERMAL 022083-001 Jul 6, 2007 ⤷  Sign Up ⤷  Sign Up
Sandoz EXELON rivastigmine FILM, EXTENDED RELEASE;TRANSDERMAL 022083-005 Aug 31, 2012 ⤷  Sign Up ⤷  Sign Up
>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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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