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Last Updated: October 29, 2020

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Rivastigmine tartrate - Generic Drug Details

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

Rivastigmine tartrate is the generic ingredient in two branded drugs marketed by Novartis, 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 twelve NDAs. Additional information is available in the individual branded drug profile pages.

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

Drug Prices for rivastigmine tartrate

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Recent Clinical Trials for rivastigmine tartrate

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

SponsorPhase
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.Phase 1/Phase 2
Taishoff Family FoundationPhase 1/Phase 2
Duke UniversityPhase 1/Phase 2

See all rivastigmine tartrate clinical trials

Generic filers with tentative approvals for RIVASTIGMINE TARTRATE
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 tartrate
Paragraph IV (Patent) Challenges for RIVASTIGMINE TARTRATE
Tradename Dosage Ingredient NDA Submissiondate
EXELON SOLUTION;ORAL rivastigmine tartrate 021025 2004-11-05
EXELON CAPSULE;ORAL rivastigmine tartrate 020823 2004-04-21

US Patents and Regulatory Information for rivastigmine tartrate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Alembic Pharms Ltd RIVASTIGMINE TARTRATE rivastigmine tartrate CAPSULE;ORAL 091689-004 Jun 12, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Watson Labs RIVASTIGMINE TARTRATE rivastigmine tartrate CAPSULE;ORAL 077129-002 Jan 8, 2008 AB RX No No   Start Trial   Start Trial   Start Trial
Orchid Hlthcare RIVASTIGMINE TARTRATE rivastigmine tartrate CAPSULE;ORAL 090879-003 Jun 10, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
Dr Reddys Labs Inc RIVASTIGMINE TARTRATE rivastigmine tartrate CAPSULE;ORAL 077130-002 Oct 31, 2007 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 tartrate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis EXELON rivastigmine tartrate CAPSULE;ORAL 020823-004 Apr 21, 2000   Start Trial   Start Trial
Novartis EXELON rivastigmine tartrate CAPSULE;ORAL 020823-003 Apr 21, 2000   Start Trial   Start Trial
Novartis EXELON rivastigmine tartrate CAPSULE;ORAL 020823-006 Apr 21, 2000   Start Trial   Start Trial
Novartis EXELON rivastigmine tartrate SOLUTION;ORAL 021025-001 Apr 21, 2000   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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