Rivastigmine - Generic Drug Details
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What are the generic sources for rivastigmine and what is the scope of freedom to operate?
Rivastigmine
is the generic ingredient in three branded drugs marketed by Sandoz, Alvogen, Amneal Pharms, Breckenridge, Mylan Technologies, Zydus Pharms, Novartis, Alembic Pharms Ltd, Apotex Inc, Aurobindo Pharma, Cadila Pharms Ltd, Chartwell Rx, Dr Reddys Labs Inc, Macleods Pharms Ltd, Orbion Pharms, Sun Pharm, and Watson Labs, and is included in eighteen NDAs. Additional information is available in the individual branded drug profile pages.There are thirty-two drug master file entries for rivastigmine. Ten suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for rivastigmine
US Patents: | 0 |
Tradenames: | 3 |
Applicants: | 17 |
NDAs: | 18 |
Drug Master File Entries: | 32 |
Finished Product Suppliers / Packagers: | 10 |
Raw Ingredient (Bulk) Api Vendors: | 94 |
Clinical Trials: | 101 |
Patent Applications: | 6,959 |
Drug Prices: | Drug price trends for rivastigmine |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for rivastigmine |
What excipients (inactive ingredients) are in rivastigmine? | rivastigmine excipients list |
DailyMed Link: | rivastigmine at DailyMed |
Recent Clinical Trials for rivastigmine
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
NeuroSense Therapeutics Ltd. | Phase 2 |
Luye Pharma Group Ltd. | Phase 1 |
Tergooi Hospital | Phase 4 |
Generic filers with tentative approvals for RIVASTIGMINE
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 2MG/ML | SOLUTION; ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for rivastigmine
Drug Class | Cholinesterase Inhibitor |
Mechanism of Action | Cholinesterase Inhibitors |
Medical Subject Heading (MeSH) Categories for rivastigmine
Anatomical Therapeutic Chemical (ATC) Classes for rivastigmine
Paragraph IV (Patent) Challenges for RIVASTIGMINE
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 |
US Patents and Regulatory Information for rivastigmine
Expired US Patents for rivastigmine
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Sandoz | EXELON | rivastigmine | FILM, EXTENDED RELEASE;TRANSDERMAL | 022083-001 | Jul 6, 2007 | ⤷ Sign Up | ⤷ Sign Up |
Sandoz | EXELON | rivastigmine | FILM, EXTENDED RELEASE;TRANSDERMAL | 022083-001 | 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 | 022083-002 | 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 | 022083-005 | Aug 31, 2012 | ⤷ Sign Up | ⤷ Sign Up |
Sandoz | EXELON | rivastigmine | FILM, EXTENDED RELEASE;TRANSDERMAL | 022083-005 | Aug 31, 2012 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for rivastigmine
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 | |
Novartis Europharm Limited | Prometax | rivastigmine | EMEA/H/C/000255 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 | 1998-12-03 | |
Sandoz GmbH | Rivastigmine Sandoz | rivastigmine | EMEA/H/C/001183 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 | 2009-12-10 | |
Hexal AGĀ | Rivastigmine Hexal | rivastigmine | EMEA/H/C/001182 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 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
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