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EXELON Drug Profile
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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 list | 3 |
| Drug Prices: : | see details |
Pharmacology for Tradename: EXELON
| Drug Class | Cholinesterase Inhibitor |
| Mechanism of Action | Cholinesterase Inhibitors |
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;ORAL | 020823-003 | Apr 21, 2000 | RX | Yes | ||||||||||||||||||||||
Novartis | EXELON | rivastigmine | FILM, EXTENDED RELEASE;TRANSDERMAL | 022083-001 | Jul 6, 2007 | RX | No | 6,316,023 | Jan 8, 2019 | Y | |||||||||||||||||||
Novartis | EXELON | rivastigmine tartrate | CAPSULE;ORAL | 020823-006 | Apr 21, 2000 | RX | Yes | ||||||||||||||||||||||
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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;ORAL | 020823-004 | Apr 21, 2000 | 4,948,807 | <disabled> | ||||||||||||||||||||||
Novartis | EXELON | rivastigmine tartrate | SOLUTION;ORAL | 021025-001 | Apr 21, 2000 | 5,602,176 | <disabled> | ||||||||||||||||||||||
Novartis | EXELON | rivastigmine tartrate | CAPSULE;ORAL | 020823-004 | Apr 21, 2000 | 5,602,176 | <disabled> | ||||||||||||||||||||||
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Paragraph IV activity for: EXELON
| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| rivastigmine | Transdermal System Extended-release | 13.3 mg/24 hr | Exelon | 1/22/2013 |
| rivastigmine | Transdermal System Extended-release | 4.6 mg/24 hr and 9.5 mg/24 hr | Exelon Patch | 4/27/2011 |
| rivastigmine tartrate | Oral Solution | 2 mg/mL | Exelon | 11/5/2004 |
| rivastigmine tartrate | Capsules | 1.5 mg, 3 mg, 4.5 mg and 6 mg | Exelon | 4/21/2004 |
International Patent Family for Tradename: EXELON
| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Poland | 341347 | <disabled in preview> | |||||||||||||||||||||||||||
| World Intellectual Property Organization (WIPO) | 9934782 | <disabled in preview> | |||||||||||||||||||||||||||
| Hungary | 227159 | <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/GB98/041 | United 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 | ||||||||||||||||||||||||||
| C0038 | Belgium | <disabled> | PRODUCT NAME: RIVASTIGMINE; NAT. REGISTRATION NO/DATE: EU/1/98/066/001 19980512; FIRST REGISTRATION: CH 54275 01 19970731 | ||||||||||||||||||||||||||
| 80031 | Netherlands | <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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