Rivastigmine tartrate - Generic Drug Details
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What are the generic sources for rivastigmine tartrate and what is the scope of patent protection?
Rivastigmine tartrate
is the generic ingredient in two branded drugs marketed by 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 twelve NDAs. Additional information is available in the individual branded drug profile pages.There are fifteen drug master file entries for rivastigmine tartrate. Thirteen suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for rivastigmine tartrate
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 11 |
NDAs: | 12 |
Drug Master File Entries: | 15 |
Finished Product Suppliers / Packagers: | 13 |
Raw Ingredient (Bulk) Api Vendors: | 130 |
Clinical Trials: | 2 |
Patent Applications: | 4,357 |
Drug Prices: | Drug price trends for rivastigmine tartrate |
What excipients (inactive ingredients) are in rivastigmine tartrate? | rivastigmine tartrate excipients list |
DailyMed Link: | rivastigmine tartrate at DailyMed |
Recent Clinical Trials for rivastigmine tartrate
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Taishoff Family Foundation | Phase 1/Phase 2 |
Hugo W. Moser Research Institute at Kennedy Krieger, Inc. | Phase 1/Phase 2 |
Duke University | Phase 1/Phase 2 |
Generic filers with tentative approvals for RIVASTIGMINE TARTRATE
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 tartrate
Drug Class | Cholinesterase Inhibitor |
Mechanism of Action | Cholinesterase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for rivastigmine tartrate
Paragraph IV (Patent) Challenges for RIVASTIGMINE TARTRATE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
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 rivastigmine tartrate
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sun Pharm | RIVASTIGMINE TARTRATE | rivastigmine tartrate | CAPSULE;ORAL | 077131-001 | Oct 22, 2007 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Chartwell Rx | RIVASTIGMINE TARTRATE | rivastigmine tartrate | CAPSULE;ORAL | 207797-004 | Sep 28, 2017 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Watson Labs | RIVASTIGMINE TARTRATE | rivastigmine tartrate | CAPSULE;ORAL | 077129-001 | Jan 8, 2008 | AB | RX | No | 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 rivastigmine tartrate
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Novartis | EXELON | rivastigmine tartrate | SOLUTION;ORAL | 021025-001 | Apr 21, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | EXELON | rivastigmine tartrate | CAPSULE;ORAL | 020823-004 | Apr 21, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | EXELON | rivastigmine tartrate | CAPSULE;ORAL | 020823-006 | Apr 21, 2000 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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