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Generated: October 21, 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, Alembic Pharms Ltd, and Ajanta Pharma Ltd, and is included in fourteen 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-five patent family members in twenty-six countries and three supplementary protection certificates in three 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

US Patents:2
Tradenames:3
Applicants:12
NDAs:14
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
u► 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
Alvogen Malta
RIVASTIGMINE
rivastigmine
FILM, EXTENDED RELEASE;TRANSDERMAL204403-003Aug 31, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Orchid Hlthcare
RIVASTIGMINE TARTRATE
rivastigmine tartrate
CAPSULE;ORAL090879-003Jun 10, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Alvogen Malta
RIVASTIGMINE
rivastigmine
FILM, EXTENDED RELEASE;TRANSDERMAL204403-002Sep 3, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Sun Pharm Inds Ltd
RIVASTIGMINE TARTRATE
rivastigmine tartrate
CAPSULE;ORAL077131-003Oct 22, 2007ABRXNoNo► Subscribe► Subscribe► Subscribe
Watson Labs
RIVASTIGMINE TARTRATE
rivastigmine tartrate
CAPSULE;ORAL077129-003Jan 8, 2008ABRXNoNo► Subscribe► Subscribe► Subscribe
Aurobindo Pharma Ltd
RIVASTIGMINE TARTRATE
rivastigmine tartrate
CAPSULE;ORAL204572-001Mar 25, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Apotex Inc
RIVASTIGMINE TARTRATE
rivastigmine tartrate
CAPSULE;ORAL091072-003May 16, 2013ABRXNoNo► Subscribe► Subscribe► Subscribe
Cadila Pharms Ltd
RIVASTIGMINE TARTRATE
rivastigmine tartrate
CAPSULE;ORAL203844-003Feb 13, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Novartis
EXELON
rivastigmine
FILM, EXTENDED RELEASE;TRANSDERMAL022083-002Jul 6, 2007ABRXYesYes► Subscribe► SubscribeY ► Subscribe
Dr Reddys Labs Inc
RIVASTIGMINE TARTRATE
rivastigmine tartrate
CAPSULE;ORAL077130-001Oct 31, 2007ABRXNoNo► 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;TRANSDERMAL022083-002Jul 6, 2007► Subscribe► Subscribe
Novartis
EXELON
rivastigmine
FILM, EXTENDED RELEASE;TRANSDERMAL022083-001Jul 6, 2007► Subscribe► Subscribe
Novartis
EXELON
rivastigmine
FILM, EXTENDED RELEASE;TRANSDERMAL022083-005Aug 31, 2012► Subscribe► Subscribe
Novartis
EXELON
rivastigmine
FILM, EXTENDED RELEASE;TRANSDERMAL022083-002Jul 6, 2007► Subscribe► Subscribe
Novartis
EXELON
rivastigmine
FILM, EXTENDED RELEASE;TRANSDERMAL022083-001Jul 6, 2007► Subscribe► Subscribe
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International Patent Family for Ingredient: rivastigmine

Country Document Number Estimated Expiration
Australia745661► Subscribe
Australia2278599► Subscribe
Japan2002500178► Subscribe
United Kingdom9800526► Subscribe
Turkey200001688► Subscribe
Slovakia10532000► Subscribe
Hungary0004300► Subscribe
MexicoPA00006438► Subscribe
Norway328390► Subscribe
Poland201328► 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
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
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
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Serving leading biopharmaceutical companies globally:

Medtronic
Deloitte
Fish and Richardson
Daiichi Sankyo
Cerilliant
Chinese Patent Office
Merck
Accenture
Farmers Insurance
Healthtrust

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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