Risperidone is the generic ingredient in three branded drugs marketed by Janssen Pharms, Amneal Pharms, Ani Pharms Inc, Apotex Inc, Aurobindo Pharma, Bio Pharm Inc, Precision Dose, Roxane, Taro, Tris Pharma Inc, Vintage, Wockhardt, Actavis Labs Fl Inc, Dr Reddys Labs Ltd, Jubilant Generics, Mylan Pharms Inc, Par Pharm, Ranbaxy, Sandoz, Sun Pharm Inds Ltd, Teva, Zydus Pharms Usa, Ajanta Pharma Ltd, Cadista Pharms, Cipla, Mylan, Pliva Hrvatska Doo, Prinston Inc, Prosam Labs, Ratiopharm, Sun Pharm Inds Inc, Synthon Pharms, Torrent Pharms, Watson Labs, West Ward Pharms, and Zydus Pharms Usa Inc, and is included in fourty-seven NDAs. There are sixteen patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.
There are twenty-nine drug master file entries for risperidone. Six suppliers are listed for this compound. There is one tentative approval for this compound.
|Drug Class||Atypical Antipsychotic |
|Applicant||Tradename||Generic Name||Dosage||NDA||Approval Date||Type||RLD||Patent No.||Patent Expiration||Product||Substance||Delist Req.||Exclusivity Expiration|
|INJECTABLE;INTRAMUSCULAR||021346||Oct 29, 2003||RX||No||5,965,168*PED||<disabled>||Y||<disabled>|
|SOLUTION;ORAL||020588||Jun 10, 1996||RX||Yes||5,453,425*PED||<disabled>||Y||<disabled>|
|TABLET, ORALLY DISINTEGRATING;ORAL||021444||Dec 23, 2004||RX||No||5,648,093*PED||<disabled>||Y||<disabled>|
West Ward Pharms
|TABLET;ORAL||078740||May 29, 2009||DISCN||No||<disabled>||<disabled>|
|TABLET;ORAL||078187||Oct 22, 2009||DISCN||No||<disabled>||<disabled>|
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