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Last Updated: August 14, 2020

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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 Noveltech Inc, Alembic Pharms Ltd, Apotex Inc, Aurobindo Pharma Ltd, Cadila Pharms Ltd, Chartwell Rx, Dr Reddys Labs Inc, Macleods Pharms Ltd, Orchid Hlthcare, 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. Nine 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
University of BristolPhase 3
Royal United Hospitals Bath NHS Foundation TrustPhase 3
Ain Shams UniversityPhase 1/Phase 2

See all RIVASTIGMINE clinical trials

Generic filers with tentative approvals for RIVASTIGMINE
Applicant Application No. Strength Dosage Form
  Start Trial  Start 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 NDA Submissiondate
EXELON FILM, EXTENDED RELEASE;TRANSDERMAL rivastigmine 022083 2013-01-22
EXELON FILM, EXTENDED RELEASE;TRANSDERMAL rivastigmine 022083 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
Sun Pharm RIVASTIGMINE TARTRATE rivastigmine tartrate CAPSULE;ORAL 077131-002 Oct 22, 2007 AB RX No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd RIVASTIGMINE TARTRATE rivastigmine tartrate CAPSULE;ORAL 204572-003 Mar 25, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Novartis EXELON rivastigmine tartrate CAPSULE;ORAL 020823-006 Apr 21, 2000 DISCN Yes No   Start Trial   Start Trial   Start Trial
Apotex Inc RIVASTIGMINE TARTRATE rivastigmine tartrate CAPSULE;ORAL 091072-001 May 16, 2013 DISCN No No   Start Trial   Start Trial   Start Trial
Chartwell Rx RIVASTIGMINE TARTRATE rivastigmine tartrate CAPSULE;ORAL 207797-004 Sep 28, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Watson Labs RIVASTIGMINE TARTRATE rivastigmine tartrate CAPSULE;ORAL 077129-004 Jan 8, 2008 AB RX No No   Start Trial   Start Trial   Start Trial
Macleods Pharms Ltd RIVASTIGMINE TARTRATE rivastigmine tartrate CAPSULE;ORAL 203148-002 Aug 22, 2014 AB RX No No   Start Trial   Start Trial   Start 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
Novartis EXELON rivastigmine FILM, EXTENDED RELEASE;TRANSDERMAL 022083-002 Jul 6, 2007   Start Trial   Start Trial
Novartis EXELON rivastigmine FILM, EXTENDED RELEASE;TRANSDERMAL 022083-001 Jul 6, 2007   Start Trial   Start Trial
Novartis EXELON rivastigmine FILM, EXTENDED RELEASE;TRANSDERMAL 022083-002 Jul 6, 2007   Start Trial   Start Trial
Novartis EXELON rivastigmine FILM, EXTENDED RELEASE;TRANSDERMAL 022083-005 Aug 31, 2012   Start Trial   Start Trial
Novartis EXELON rivastigmine FILM, EXTENDED RELEASE;TRANSDERMAL 022083-001 Jul 6, 2007   Start Trial   Start Trial
Novartis EXELON rivastigmine FILM, EXTENDED RELEASE;TRANSDERMAL 022083-005 Aug 31, 2012   Start Trial   Start Trial
Novartis EXELON rivastigmine FILM, EXTENDED RELEASE;TRANSDERMAL 022083-002 Jul 6, 2007   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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