Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 21, 2019

DrugPatentWatch Database Preview

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. Fourteen 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

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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

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Recent Litigation for rivastigmine tartrate

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District Court Litigation
Case NameDate
Novartis Pharmaceuticals Corporation v. Par Pharmaceutical Inc.2013-08-22
Novartis Pharmaceuticals Corporation v. Noven Pharmaceuticals Inc.2013-04-03
Novartis Pharmaceuticals Corporation v. Watson Laboratories, Inc.2011-11-10

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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
Cadila Pharms Ltd RIVASTIGMINE TARTRATE rivastigmine tartrate CAPSULE;ORAL 203844-004 Feb 13, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Novartis EXELON rivastigmine tartrate SOLUTION;ORAL 021025-001 Apr 21, 2000 DISCN 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
Orchid Hlthcare RIVASTIGMINE TARTRATE rivastigmine tartrate CAPSULE;ORAL 090879-001 Jun 10, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
Sun Pharm RIVASTIGMINE TARTRATE rivastigmine tartrate CAPSULE;ORAL 077131-004 Oct 22, 2007 AB RX No No   Start Trial   Start Trial   Start Trial
Alembic Pharms Ltd RIVASTIGMINE TARTRATE rivastigmine tartrate CAPSULE;ORAL 091689-003 Jun 12, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Novartis EXELON rivastigmine tartrate CAPSULE;ORAL 020823-003 Apr 21, 2000 DISCN Yes 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 020823-003 Apr 21, 2000   Start Trial   Start Trial
Novartis EXELON rivastigmine tartrate CAPSULE;ORAL 020823-004 Apr 21, 2000   Start Trial   Start Trial
Novartis EXELON rivastigmine tartrate CAPSULE;ORAL 020823-005 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 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
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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Serving leading biopharmaceutical companies globally:

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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 verifification 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.