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Rivastigmine - Generic Drug Details
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What are the generic sources for rivastigmine and what is the scope of patent protection?
Rivastigmine
is the generic ingredient in three branded drugs marketed by Novartis, Alvogen, Amneal Pharms, Breckenridge, Mylan Technologies, Zydus Noveltech Inc, Alembic Pharms Ltd, Apotex Inc, Aurobindo Pharma Ltd, Cadila Pharms Ltd, Chartwell Rx, Dr Reddys Labs Inc, Macleods Pharms Ltd, Orchid Hlthcare, 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: | 16 |
NDAs: | 18 |
Drug Master File Entries: | 32 |
Suppliers / Packagers: | 10 |
Bulk Api Vendors: | 73 |
Clinical Trials: | 90 |
Patent Applications: | 7,037 |
Formulation / Manufacturing: | see details |
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 |
---|---|
University of Maryland, Baltimore | Phase 2 |
Royal United Hospitals Bath NHS Foundation Trust | Phase 3 |
University of Bristol | Phase 3 |
Generic filers with tentative approvals for RIVASTIGMINE
Applicant | Application No. | Strength | Dosage Form |
Start Trial | Start Trial | 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
Paragraph IV (Patent) Challenges for RIVASTIGMINE
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 |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Zydus Noveltech Inc | RIVASTIGMINE | rivastigmine | FILM, EXTENDED RELEASE;TRANSDERMAL | 206318-003 | Mar 4, 2019 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Apotex Inc | RIVASTIGMINE TARTRATE | rivastigmine tartrate | CAPSULE;ORAL | 091072-002 | May 16, 2013 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
Aurobindo Pharma Ltd | RIVASTIGMINE TARTRATE | rivastigmine tartrate | CAPSULE;ORAL | 204572-002 | Mar 25, 2016 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Zydus Noveltech Inc | RIVASTIGMINE | rivastigmine | FILM, EXTENDED RELEASE;TRANSDERMAL | 206318-002 | Mar 4, 2019 | AB | RX | No | 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 | ||||
Sun Pharm | RIVASTIGMINE TARTRATE | rivastigmine tartrate | CAPSULE;ORAL | 077131-004 | Oct 22, 2007 | AB | RX | 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 rivastigmine
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 | FILM, EXTENDED RELEASE;TRANSDERMAL | 022083-001 | Jul 6, 2007 | Start Trial | Start Trial |
Novartis | EXELON | rivastigmine | FILM, EXTENDED RELEASE;TRANSDERMAL | 022083-002 | Jul 6, 2007 | Start Trial | Start Trial |
Novartis | EXELON | rivastigmine | FILM, EXTENDED RELEASE;TRANSDERMAL | 022083-005 | Aug 31, 2012 | Start Trial | Start Trial |
Novartis | EXELON | rivastigmine | FILM, EXTENDED RELEASE;TRANSDERMAL | 022083-001 | Jul 6, 2007 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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