RIVASTIGMINE Drug Patent Profile
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Which patents cover Rivastigmine, and when can generic versions of Rivastigmine launch?
Rivastigmine is a drug marketed by Alvogen, Amneal Pharms, Breckenridge, Mylan Technologies, Zydus Pharms, 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 fifteen NDAs.
The generic ingredient in RIVASTIGMINE is rivastigmine tartrate. There are thirty-two drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the rivastigmine tartrate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Rivastigmine
A generic version of RIVASTIGMINE was approved as rivastigmine tartrate by SUN PHARM on October 22nd, 2007.
Summary for RIVASTIGMINE
US Patents: | 0 |
Applicants: | 15 |
NDAs: | 15 |
Finished Product Suppliers / Packagers: | 9 |
Raw Ingredient (Bulk) Api Vendors: | 94 |
Clinical Trials: | 100 |
Patent Applications: | 5,168 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information 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 |
---|---|
Luye Pharma Group Ltd. | Phase 1 |
St. Antonius Hospital | Phase 4 |
Tergooi Hospital | Phase 4 |
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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Macleods Pharms Ltd | RIVASTIGMINE TARTRATE | rivastigmine tartrate | CAPSULE;ORAL | 203148-002 | Aug 22, 2014 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Chartwell Rx | RIVASTIGMINE TARTRATE | rivastigmine tartrate | CAPSULE;ORAL | 207797-001 | Sep 28, 2017 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Sun Pharm | RIVASTIGMINE TARTRATE | rivastigmine tartrate | CAPSULE;ORAL | 077131-002 | Oct 22, 2007 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Orbion Pharms | RIVASTIGMINE TARTRATE | rivastigmine tartrate | CAPSULE;ORAL | 090879-002 | Jun 10, 2015 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity 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 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |