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RISPERIDONE Drug Profile
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When do Risperidone patents expire, and what generic alternatives are available?
Risperidone is a drug marketed by Amneal Pharms, Ani Pharms Inc, Aurobindo Pharma Ltd, Hikma, Lannett Co Inc, Pharm Assoc, Precision Dose, Taro, Torrent, Tris Pharma Inc, Wockhardt, Actavis Labs Fl Inc, Dr Reddys Labs Ltd, Heritage Pharma, Jubilant Generics, Mylan Pharms Inc, Par Pharm, Sandoz, Sun Pharm Inds Ltd, Zydus Pharms Usa, Ajanta Pharma Ltd, Amneal, Apotex Inc, Celltrion, Chartwell Molecular, Jubilant Cadista, Mylan, Prinston Inc, Ratiopharm, Renata, Rising, Sun Pharm Inds Inc, Synthon Pharms, Torrent Pharms, Watson Labs, West Ward Pharms, and Zydus Pharms Usa Inc. and is included in forty-four NDAs.
The generic ingredient in RISPERIDONE is risperidone. There are thirty drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the risperidone profile page.
US ANDA Litigation and Generic Entry Outlook for Risperidone
A generic version of RISPERIDONE was approved as risperidone by APOTEX INC on September 15th, 2008.
Summary for RISPERIDONE
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Recent Clinical Trials for RISPERIDONE
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| Sponsor | Phase |
|---|---|
| University of Georgia | Phase 4 |
| Hartford Hospital | Phase 4 |
| University of Texas Southwestern Medical Center | Phase 4 |
Pharmacology for RISPERIDONE
| Drug Class | Atypical Antipsychotic |
Medical Subject Heading (MeSH) Categories for RISPERIDONE
Paragraph IV (Patent) Challenges for RISPERIDONE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| RISPERDAL | TABLET, ORALLY DISINTEGRATING;ORAL | risperidone | 021444 | 2005-04-11 |
| RISPERDAL | TABLET, ORALLY DISINTEGRATING;ORAL | risperidone | 021444 | 2005-03-23 |
| RISPERDAL | TABLET;ORAL | risperidone | 020272 | |
| RISPERDAL | SOLUTION;ORAL | risperidone | 020588 |
US Patents and Regulatory Information for RISPERIDONE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Apotex Inc | RISPERIDONE | risperidone | TABLET;ORAL | 077953-001 | Sep 15, 2008 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Heritage Pharma | RISPERIDONE | risperidone | TABLET;ORAL | 077769-003 | Oct 16, 2008 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Par Pharm | RISPERIDONE | risperidone | TABLET, ORALLY DISINTEGRATING;ORAL | 077494-005 | Apr 30, 2009 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Mylan Pharms Inc | RISPERIDONE | risperidone | TABLET, ORALLY DISINTEGRATING;ORAL | 091537-001 | Mar 30, 2011 | DISCN | 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 |
