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Serving leading biopharmaceutical companies globally:

Deloitte
Chinese Patent Office
Novartis
Cerilliant
Farmers Insurance
Harvard Business School
Fuji
Cantor Fitzgerald
Julphar
Cipla

Generated: December 16, 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 Novartis, Alvogen Malta, Ajanta Pharma Ltd, Alembic Pharms Ltd, Apotex Inc, Aurobindo Pharma Ltd, Cadila Pharms Ltd, Dr Reddys Labs Inc, Macleods Pharms Ltd, Orchid Hlthcare, Sun Pharm Inds Ltd, and Watson Labs, 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-seven patent family members in twenty-seven 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.

Pharmacology for rivastigmine

Medical Subject Heading (MeSH) Categories for 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 MaltaRIVASTIGMINErivastigmineFILM, EXTENDED RELEASE;TRANSDERMAL204403-002Sep 3, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Alvogen MaltaRIVASTIGMINErivastigmineFILM, EXTENDED RELEASE;TRANSDERMAL204403-003Aug 31, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Alvogen MaltaRIVASTIGMINErivastigmineFILM, EXTENDED RELEASE;TRANSDERMAL204403-001Sep 3, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Watson LabsRIVASTIGMINE TARTRATErivastigmine tartrateCAPSULE;ORAL077129-004Jan 8, 2008ABRXNoNo► Subscribe► Subscribe► Subscribe
NovartisEXELONrivastigmineFILM, EXTENDED RELEASE;TRANSDERMAL022083-005Aug 31, 2012ABRXYesNo► Subscribe► SubscribeY► Subscribe
Macleods Pharms LtdRIVASTIGMINE TARTRATErivastigmine tartrateCAPSULE;ORAL203148-001Aug 22, 2014ABRXNoNo► Subscribe► Subscribe► Subscribe
NovartisEXELONrivastigmine tartrateCAPSULE;ORAL020823-003Apr 21, 2000ABRXYesYes► Subscribe► Subscribe► Subscribe
NovartisEXELONrivastigmineFILM, EXTENDED RELEASE;TRANSDERMAL022083-005Aug 31, 2012ABRXYesNo► Subscribe► SubscribeY► Subscribe
Aurobindo Pharma LtdRIVASTIGMINE TARTRATErivastigmine tartrateCAPSULE;ORAL204572-002Mar 25, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
NovartisEXELONrivastigmineFILM, EXTENDED RELEASE;TRANSDERMAL022083-001Jul 6, 2007ABRXYesNo► Subscribe► SubscribeY► 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
NovartisEXELONrivastigmineFILM, EXTENDED RELEASE;TRANSDERMAL022083-001Jul 6, 2007► Subscribe► Subscribe
NovartisEXELONrivastigmineFILM, EXTENDED RELEASE;TRANSDERMAL022083-005Aug 31, 2012► Subscribe► Subscribe
NovartisEXELONrivastigmineFILM, EXTENDED RELEASE;TRANSDERMAL022083-002Jul 6, 2007► Subscribe► Subscribe
NovartisEXELONrivastigmineFILM, EXTENDED RELEASE;TRANSDERMAL022083-002Jul 6, 2007► Subscribe► Subscribe
NovartisEXELONrivastigmineFILM, EXTENDED RELEASE;TRANSDERMAL022083-001Jul 6, 2007► Subscribe► Subscribe
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International Patent Family for Ingredient: rivastigmine

Country Document Number Estimated Expiration
Japan3820103► Subscribe
Japan2002500178► Subscribe
South Korea20010033072► Subscribe
South Korea100569051► Subscribe
Slovenia1047409► Subscribe
Israel137100► Subscribe
MexicoPA00006438► Subscribe
China1288375► Subscribe
Norway328390► Subscribe
Australia2278599► 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
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
C0038Belgium► SubscribePRODUCT NAME: RIVASTIGMINE; NAT. REGISTRATION NO/DATE: EU/1/98/066/001 19980512; FIRST REGISTRATION: CH 54275 01 19970731
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:

Dow
Express Scripts
McKesson
Medtronic
Baxter
Merck
Teva
Argus Health
Chinese Patent Office
Accenture

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