EXELON Drug Patent Profile
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When do Exelon patents expire, and when can generic versions of Exelon launch?
Exelon is a drug marketed by Novartis and Sandoz and is included in three NDAs.
The generic ingredient in EXELON is rivastigmine. There are thirty-two drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the rivastigmine profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Exelon
A generic version of EXELON was approved as rivastigmine by ALVOGEN on August 31st, 2015.
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Questions you can ask:
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Summary for EXELON
US Patents: | 0 |
Applicants: | 2 |
NDAs: | 3 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 94 |
Clinical Trials: | 41 |
Patent Applications: | 4,767 |
Drug Prices: | Drug price information for EXELON |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for EXELON |
What excipients (inactive ingredients) are in EXELON? | EXELON excipients list |
DailyMed Link: | EXELON at DailyMed |
Recent Clinical Trials for EXELON
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Luye Pharma Group Ltd. | Phase 1 |
Ain Shams University | Phase 1/Phase 2 |
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 | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
EXELON | Transdermal System Extended-release | rivastigmine | 13.3 mg/24 hr | 022083 | 1 | 2013-01-22 |
EXELON | Transdermal System Extended-release | rivastigmine | 4.6 mg/24 hr and 9.5 mg/24 hr | 022083 | 1 | 2011-04-27 |
EXELON | Oral Solution | rivastigmine tartrate | 2 mg/mL | 021025 | 1 | 2004-11-05 |
EXELON | Capsules | rivastigmine tartrate | 1.5 mg, 3 mg, 4.5 mg and 6 mg | 020823 | 3 | 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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Sandoz | EXELON | rivastigmine | FILM, EXTENDED RELEASE;TRANSDERMAL | 022083-005 | Aug 31, 2012 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Novartis | EXELON | rivastigmine tartrate | CAPSULE;ORAL | 020823-006 | Apr 21, 2000 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Novartis | EXELON | rivastigmine tartrate | SOLUTION;ORAL | 021025-001 | Apr 21, 2000 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>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 |
---|---|---|---|---|---|---|---|
Sandoz | EXELON | rivastigmine | FILM, EXTENDED RELEASE;TRANSDERMAL | 022083-002 | Jul 6, 2007 | ⤷ Sign Up | ⤷ Sign Up |
Sandoz | EXELON | rivastigmine | FILM, EXTENDED RELEASE;TRANSDERMAL | 022083-002 | Jul 6, 2007 | ⤷ Sign Up | ⤷ Sign Up |
Sandoz | EXELON | rivastigmine | FILM, EXTENDED RELEASE;TRANSDERMAL | 022083-001 | Jul 6, 2007 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | EXELON | rivastigmine tartrate | CAPSULE;ORAL | 020823-003 | Apr 21, 2000 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for EXELON
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Actavis Group PTC ehf | Rivastigmine Actavis | rivastigmine | EMEA/H/C/002036 Symptomatic treatment of mild to moderately severe Alzheimer's dementia.Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson's disease. |
Authorised | yes | no | no | 2011-06-16 | |
Krka, d.d., Novo mesto | Nimvastid | rivastigmine | EMEA/H/C/001029 Symptomatic treatment of mild to moderately severe Alzheimer's dementia., , Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson's disease., |
Authorised | yes | no | no | 2009-05-11 | |
1 A Pharma GmbH | Rivastigmine 1 A Pharma | rivastigmine | EMEA/H/C/001181 Symptomatic treatment of mild to moderately severe Alzheimer's dementia.Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson's disease. |
Authorised | no | no | no | 2009-12-11 | |
Novartis Europharm Limited | Exelon | rivastigmine | EMEA/H/C/000169 Symptomatic treatment of mild to moderately severe Alzheimer's dementia.Symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson's disease. |
Authorised | no | no | no | 1998-05-11 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for EXELON
See the table below for patents covering EXELON around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Norway | 20003472 | ⤷ Sign Up | |
Denmark | 99186 | ⤷ Sign Up | |
Poland | 201328 | ⤷ Sign Up | |
Austria | 394190 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for EXELON
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0193926 | C980031 | Netherlands | ⤷ Sign Up | 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 | ⤷ Sign Up | 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 | ⤷ Sign Up | 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 |