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Last Updated: July 3, 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 freedom to operate?

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

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SponsorPhase
Royal United Hospitals Bath NHS Foundation TrustPhase 3
University of BristolPhase 3
Ain Shams UniversityPhase 1/Phase 2

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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
Orchid Hlthcare RIVASTIGMINE TARTRATE rivastigmine tartrate CAPSULE;ORAL 090879-002 Jun 10, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
Dr Reddys Labs Inc RIVASTIGMINE TARTRATE rivastigmine tartrate CAPSULE;ORAL 077130-001 Oct 31, 2007 AB RX No Yes   Start Trial   Start Trial   Start Trial
Cadila Pharms Ltd RIVASTIGMINE TARTRATE rivastigmine tartrate CAPSULE;ORAL 203844-003 Feb 13, 2017 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 022083-002 Jul 6, 2007   Start Trial   Start Trial
Novartis EXELON rivastigmine FILM, EXTENDED RELEASE;TRANSDERMAL 022083-001 Jul 6, 2007   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Baxter
Johnson and Johnson
Moodys
Express Scripts
Colorcon

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.