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EXELON Drug Profile
» See Plans and Pricing
When do Exelon patents expire, and when can generic versions of Exelon launch?
Exelon is a drug marketed by Novartis and is included in three NDAs.
The generic ingredient in EXELON is rivastigmine. There are thirty-two drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the rivastigmine profile page.
US ANDA Litigation and Generic Entry Outlook for Exelon
A generic version of EXELON was approved as rivastigmine by ALVOGEN on August 31st, 2015.
Summary for EXELON
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 3 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 70 |
| Clinical Trials: | 29 |
| Patent Applications: | 5,409 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for EXELON |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for EXELON |
| DailyMed Link: | EXELON at DailyMed |
Recent Clinical Trials for EXELON
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Ain Shams University | Phase 1/Phase 2 |
| SocraMetrics GmbH | Phase 1 |
| SocraTec R&D GmbH | Phase 1 |
Pharmacology for EXELON
| Drug Class | Cholinesterase Inhibitor |
| Mechanism of Action | Cholinesterase Inhibitors |
Paragraph IV (Patent) Challenges for EXELON
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| EXELON | FILM, EXTENDED RELEASE;TRANSDERMAL | rivastigmine | 022083 | 2013-01-22 |
| EXELON | FILM, EXTENDED RELEASE;TRANSDERMAL | rivastigmine | 022083 | 2011-04-27 |
| EXELON | SOLUTION;ORAL | rivastigmine tartrate | 021025 | 2004-11-05 |
| EXELON | CAPSULE;ORAL | rivastigmine tartrate | 020823 | 2004-04-21 |
US Patents and Regulatory Information for EXELON
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Novartis | EXELON | rivastigmine tartrate | CAPSULE;ORAL | 020823-003 | Apr 21, 2000 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Novartis | EXELON | rivastigmine | FILM, EXTENDED RELEASE;TRANSDERMAL | 022083-005 | Aug 31, 2012 | AB | RX | Yes | No | Start Trial | Start Trial | Start Trial | |||
| Novartis | EXELON | rivastigmine tartrate | CAPSULE;ORAL | 020823-006 | Apr 21, 2000 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Novartis | EXELON | rivastigmine tartrate | SOLUTION;ORAL | 021025-001 | Apr 21, 2000 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for EXELON
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Novartis | EXELON | rivastigmine | FILM, EXTENDED RELEASE;TRANSDERMAL | 022083-002 | Jul 6, 2007 | Start Trial | Start Trial |
| Novartis | EXELON | rivastigmine | FILM, EXTENDED RELEASE;TRANSDERMAL | 022083-001 | Jul 6, 2007 | Start Trial | Start Trial |
| Novartis | EXELON | rivastigmine tartrate | CAPSULE;ORAL | 020823-005 | Apr 21, 2000 | Start Trial | Start Trial |
| Novartis | EXELON | rivastigmine tartrate | CAPSULE;ORAL | 020823-003 | Apr 21, 2000 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for EXELON
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Poland | 146301 | Start Trial |
| Spain | 552627 | Start Trial |
| Japan | 2625478 | Start Trial |
| Malaysia | 137602 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for EXELON
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0193926 | C980031 | Netherlands | Start Trial | 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 |
| 0193926 | 98C0038 | Belgium | Start Trial | PRODUCT NAME: RIVASTIGMINE; NAT. REGISTRATION NO/DATE: EU/1/98/066/001 19980512; FIRST REGISTRATION: CH 54275 01 19970731 |
| 0193926 | SPC/GB98/041 | United Kingdom | Start Trial | 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
