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Generated: May 29, 2017

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Risperidone - Generic Drug Details

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What are the generic sources for risperidone and what is the scope of risperidone patent protection?

is the generic ingredient in three branded drugs marketed by Ajanta Pharma Ltd, West-ward Pharms Int, Prinston Inc, Teva, Bio Pharm Inc, Sandoz, Zydus Pharms Usa, Apotex Inc, Dr Reddys Labs Ltd, Jubilant Cadista, Sun Pharm Inds Inc, Mylan Pharms Inc, Jubilant Generics, Ani Pharms Inc, West Ward Pharms, Zydus Pharms Usa Inc, Sun Pharm Inds Ltd, Cipla, Wockhardt, Janssen Pharms, Taro, Lifestar Pharma, Vintage, Tris Pharma Inc, Watson Labs, Aurobindo Pharma, Pliva Hrvatska Doo, Oxford Pharms, Amneal Pharms, Ratiopharm, Silarx Pharms Inc, Synthon Pharms, Mylan, Torrent Pharms, Par Pharm, Actavis Labs Fl Inc, and Precision Dose, and is included in forty-eight NDAs. There are nine patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Risperidone has one hundred and thirty-four patent family members in thirty-four countries.

There are thirty drug master file entries for risperidone. Sixty suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: risperidone

Drug Master File Entries: see list30
Suppliers / Packagers: see list60
Bulk Api Vendors: see list82
Clinical Trials: see list106
Patent Applications: see list5,246
Therapeutic Class:Bipolar Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:risperidone at DailyMed

Pharmacology for Ingredient: risperidone

Tentative approvals for RISPERIDONE

Applicant Application No. Strength Dosage Form
► Subscribe► Subscribe1MG/MLSOLUTION; ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apotex Inc
TABLET;ORAL077953-006Sep 15, 2008ABRXNoNo► Subscribe► Subscribe
Sun Pharm Inds Ltd
TABLET, ORALLY DISINTEGRATING;ORAL078474-001Aug 6, 2010ABRXNoNo► Subscribe► Subscribe
TABLET, ORALLY DISINTEGRATING;ORAL076908-003Mar 12, 2012ABRXNoNo► Subscribe► Subscribe
Janssen Pharms
INJECTABLE;INTRAMUSCULAR021346-004Apr 12, 2007RXYesNo5,916,598*PED► SubscribeY► Subscribe
TABLET;ORAL076228-001Jun 30, 2008ABRXNoNo► Subscribe► Subscribe
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