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Rivastigmine - Generic Drug Details

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

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

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

Summary for Generic Name: rivastigmine

Tradenames:3
Patents:2
Applicants:10
NDAs:12
Drug Master File Entries: see list32
Suppliers / Packaging: see list4
Therapeutic Class:Antidementia Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: rivastigmine

Tentative approvals for RIVASTIGMINE

Applicant Application No. Form Dosage
<disabled><disabled>SOLUTION; ORAL2MG/ML

Clinical Trials for: rivastigmine

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis
EXELON
rivastigmine
FILM, EXTENDED RELEASE;TRANSDERMAL022083-005Aug 31, 2012RXNo<disabled><disabled>
Macleods Pharms Ltd
RIVASTIGMINE TARTRATE
rivastigmine tartrate
CAPSULE;ORAL203148-002Aug 22, 2014RXNo<disabled><disabled>
Watson Labs
RIVASTIGMINE TARTRATE
rivastigmine tartrate
CAPSULE;ORAL077129-004Jan 8, 2008RXNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: rivastigmine

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
EXELON
rivastigmine
FILM, EXTENDED RELEASE;TRANSDERMAL022083-005Aug 31, 20125,602,176<disabled>
Novartis
EXELON
rivastigmine
FILM, EXTENDED RELEASE;TRANSDERMAL022083-001Jul 6, 20074,948,807<disabled>
Novartis
EXELON
rivastigmine
FILM, EXTENDED RELEASE;TRANSDERMAL022083-002Jul 6, 20074,948,807<disabled>
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International Patent Family for Ingredient: rivastigmine

Country Document Number Estimated Expiration
Germany69902875<disabled in preview>
Norway328390<disabled in preview>
Israel137100<disabled in preview>
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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<disabled>PRODUCT 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<disabled>PRODUCT NAME: RIVASTIGMINE; NAT. REGISTRATION NO/DATE: EU/1/98/066/001 19980512; FIRST REGISTRATION: CH 54275 01 19970731
C/GB98/041United Kingdom<disabled>PRODUCT 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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