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RIVASTIGMINE TARTRATE Drug Profile
When do Rivastigmine Tartrate patents expire, and what generic alternatives are available?
Rivastigmine Tartrate is a drug marketed by 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 ten NDAs.
The generic ingredient in RIVASTIGMINE TARTRATE is rivastigmine tartrate. There are thirty-two drug master file entries for this compound. Fourteen suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the rivastigmine tartrate profile page.
Summary for RIVASTIGMINE TARTRATE
Recent Clinical Trials for RIVASTIGMINE TARTRATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Duke University | Phase 1/Phase 2 |
| Hugo W. Moser Research Institute at Kennedy Krieger, Inc. | Phase 1/Phase 2 |
| Taishoff Family Foundation | Phase 1/Phase 2 |
Recent Litigation for RIVASTIGMINE TARTRATE
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Novartis Pharmaceuticals Corporation v. Par Pharmaceutical Inc. | 2013-08-22 |
| Novartis Pharmaceuticals Corporation v. Noven Pharmaceuticals Inc. | 2013-04-03 |
| Novartis Pharmaceuticals Corporation v. Watson Laboratories, Inc. | 2011-11-10 |
Pharmacology for RIVASTIGMINE TARTRATE
| Drug Class | Cholinesterase Inhibitor |
| Mechanism of Action | Cholinesterase Inhibitors |
Paragraph IV (Patent) Challenges for RIVASTIGMINE TARTRATE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| EXELON | SOLUTION;ORAL | rivastigmine tartrate | 021025 | 2004-11-05 |
| EXELON | CAPSULE;ORAL | rivastigmine tartrate | 020823 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Orchid Hlthcare | RIVASTIGMINE TARTRATE | rivastigmine tartrate | CAPSULE;ORAL | 090879-004 | Jun 10, 2015 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Macleods Pharms Ltd | RIVASTIGMINE TARTRATE | rivastigmine tartrate | CAPSULE;ORAL | 203148-004 | Aug 22, 2014 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Sun Pharm | RIVASTIGMINE TARTRATE | rivastigmine tartrate | CAPSULE;ORAL | 077131-001 | Oct 22, 2007 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Orchid Hlthcare | RIVASTIGMINE TARTRATE | rivastigmine tartrate | CAPSULE;ORAL | 090879-001 | Jun 10, 2015 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Alembic Pharms Ltd | RIVASTIGMINE TARTRATE | rivastigmine tartrate | CAPSULE;ORAL | 091689-001 | Jun 12, 2012 | 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 |
