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EXELON Drug Profile

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Exelon is a drug marketed by Novartis and is included in three NDAs. It is available from three suppliers. There are two patents protecting this drug and four Paragraph IV challenges.

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

The generic ingredient in EXELON is rivastigmine. There are thirty-two drug master file entries for this compound. Four suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the rivastigmine profile page.

Summary for Tradename: EXELON

Patents:2
Applicants:1
NDAs:3
Suppliers / Packagers: see list3

Pharmacology for Tradename: EXELON

Clinical Trials for: EXELON

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis
EXELON
rivastigmine tartrate
CAPSULE;ORAL020823-003Apr 21, 2000RXYes<disabled><disabled>
Novartis
EXELON
rivastigmine
FILM, EXTENDED RELEASE;TRANSDERMAL022083-001Jul 6, 2007RXNo6,316,023<disabled>Y <disabled>
Novartis
EXELON
rivastigmine tartrate
CAPSULE;ORAL020823-006Apr 21, 2000RXYes<disabled><disabled>
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Expired Patents for Tradename: EXELON

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
EXELON
rivastigmine tartrate
CAPSULE;ORAL020823-004Apr 21, 20004,948,807<disabled>
Novartis
EXELON
rivastigmine tartrate
CAPSULE;ORAL020823-006Apr 21, 20004,948,807<disabled>
Novartis
EXELON
rivastigmine tartrate
CAPSULE;ORAL020823-003Apr 21, 20004,948,807<disabled>
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Paragraph IV activity for: EXELON

Drugname Dosage Strength RLD Submissiondate
rivastigmineTransdermal System Extended-release13.3 mg/24 hrExelon1/22/2013
rivastigmineTransdermal System Extended-release4.6 mg/24 hr and 9.5 mg/24 hrExelon Patch4/27/2011
rivastigmine tartrateOral Solution2 mg/mLExelon11/5/2004
rivastigmine tartrateCapsules1.5 mg, 3 mg, 4.5 mg and 6 mgExelon4/21/2004

International Patent Family for Tradename: EXELON

Country Document Number Estimated Expiration
European Patent Office1047409<disabled in preview>
World Intellectual Property Organization (WIPO)9934782<disabled in preview>
Austria223711<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: EXELON

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
C0038Belgium<disabled>PRODUCT NAME: RIVASTIGMINE; NAT. REGISTRATION NO/DATE: EU/1/98/066/001 19980512; FIRST REGISTRATION: CH 54275 01 19970731
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
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