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Serving 500+ biopharmaceutical companies globally:

Chinese Patent Office
Healthtrust
Deloitte
Cerilliant
Dow
Accenture
Cipla
Cantor Fitzgerald
McKinsey
Covington

Generated: September 22, 2017

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Rivastigmine - Generic Drug Details

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

Rivastigmine
is the generic ingredient in three branded drugs marketed by Alvogen Malta, Novartis, Watson Labs, Dr Reddys Labs Inc, Sun Pharm Inds Ltd, Cadila Pharms Ltd, Macleods Pharms Ltd, Apotex Inc, Aurobindo Pharma Ltd, Orchid Hlthcare, and Alembic Pharms Ltd, and is included in thirteen NDAs. There are two patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Rivastigmine has thirty-two patent family members in twenty-six countries.

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

Summary for Generic Name: rivastigmine

Tradenames:3
Patents:2
Applicants:11
NDAs:13
Drug Master File Entries: see list32
Suppliers / Packagers: see list5
Bulk Api Vendors: see list45
Clinical Trials: see list78
Patent Applications: see list6,333
Therapeutic Class:Antidementia Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:rivastigmine at DailyMed

Pharmacology for Ingredient: rivastigmine

Tentative approvals for RIVASTIGMINE

Applicant Application No. Strength Dosage Form
► Subscribe► Subscribe2MG/MLSOLUTION; ORAL
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;ORAL091689-004Jun 12, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe
Sun Pharm Inds Ltd
RIVASTIGMINE TARTRATE
rivastigmine tartrate
CAPSULE;ORAL077131-004Oct 22, 2007ABRXNoNo► Subscribe► Subscribe► Subscribe
Novartis
EXELON
rivastigmine
FILM, EXTENDED RELEASE;TRANSDERMAL022083-002Jul 6, 2007ABRXYesYes► Subscribe► SubscribeY ► Subscribe
Macleods Pharms Ltd
RIVASTIGMINE TARTRATE
rivastigmine tartrate
CAPSULE;ORAL203148-002Aug 22, 2014ABRXNoNo► Subscribe► Subscribe► Subscribe
Alembic Pharms Ltd
RIVASTIGMINE TARTRATE
rivastigmine tartrate
CAPSULE;ORAL091689-001Jun 12, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe
Macleods Pharms Ltd
RIVASTIGMINE TARTRATE
rivastigmine tartrate
CAPSULE;ORAL203148-004Aug 22, 2014ABRXNoNo► Subscribe► Subscribe► Subscribe
Sun Pharm Inds Ltd
RIVASTIGMINE TARTRATE
rivastigmine tartrate
CAPSULE;ORAL077131-001Oct 22, 2007ABRXNoNo► Subscribe► Subscribe► Subscribe
Dr Reddys Labs Inc
RIVASTIGMINE TARTRATE
rivastigmine tartrate
CAPSULE;ORAL077130-001Oct 31, 2007ABRXNoNo► Subscribe► Subscribe► Subscribe
Cadila Pharms Ltd
RIVASTIGMINE TARTRATE
rivastigmine tartrate
CAPSULE;ORAL203844-001Feb 13, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Watson Labs
RIVASTIGMINE TARTRATE
rivastigmine tartrate
CAPSULE;ORAL077129-001Jan 8, 2008ABRXNoNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: rivastigmine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
EXELON
rivastigmine
FILM, EXTENDED RELEASE;TRANSDERMAL022083-001Jul 6, 2007► Subscribe► Subscribe
Novartis
EXELON
rivastigmine
FILM, EXTENDED RELEASE;TRANSDERMAL022083-002Jul 6, 2007► Subscribe► Subscribe
Novartis
EXELON
rivastigmine
FILM, EXTENDED RELEASE;TRANSDERMAL022083-005Aug 31, 2012► Subscribe► Subscribe
Novartis
EXELON
rivastigmine
FILM, EXTENDED RELEASE;TRANSDERMAL022083-001Jul 6, 2007► Subscribe► Subscribe
Novartis
EXELON
rivastigmine
FILM, EXTENDED RELEASE;TRANSDERMAL022083-002Jul 6, 2007► Subscribe► Subscribe
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International Patent Family for Ingredient: rivastigmine

Country Document Number Estimated Expiration
Japan3820103► Subscribe
Poland201328► Subscribe
Portugal1047409► Subscribe
Israel137100► Subscribe
Hungary0004300► Subscribe
MexicoPA00006438► Subscribe
Austria223711► Subscribe
European Patent Office1047409► Subscribe
Hungary227159► Subscribe
China1129427► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: RIVASTIGMINE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB98/041United Kingdom► SubscribePRODUCT NAME: RIVASTIGMINE, AS FREE BASE OR PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: CH 5427501 19970731; CH 5427502 19970731; CH 5427503 19970731; CH 5427504 19970731; CH 5427505 19970731; CH 5427506 19970731; UK EU/1/98/066/001 19980512; UK EU/1/98/066/002 19980512; UK EU/1/98/066/003 19980512; UK EU/1/98/066/004 19980512; UK EU/1/98/066/005 19980512; UK EU/1/98/066/006 19980512; UK EU/1/98/092/023 19980512; UK EU/1/98/092/024 19980512; UK EU/1/98/092/025 19980512; UK EU/1/98/092/026 19980512; UK EU/1/98/066/025 19980512; UK EU/1/98/066/026 19980512; UK EU/1/98/092/019 19980512; UK EU/1/98/092/020 19980512; UK EU/1/98/092/021 19980512; UK EU/1/98/092/022 19980512; UK EU/1/98/0
C0038Belgium► SubscribePRODUCT NAME: RIVASTIGMINE; NAT. REGISTRATION NO/DATE: EU/1/98/066/001 19980512; FIRST REGISTRATION: CH 54275 01 19970731
80031Netherlands► SubscribePRODUCT NAME: RIVASTIGMINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER RIVASTIGMINE WATERSTOFTAR- TRAAT; REGISTRATION NO/DATE: EU/1/98/066/001 - EU/1/98/066/012 19980512
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Serving 500+ biopharmaceutical companies globally:

Boehringer Ingelheim
McKinsey
Cerilliant
Chubb
Medtronic
QuintilesIMS
Chinese Patent Office
Moodys
Harvard Business School
McKesson

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.

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