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Risperidone - Generic Drug Details

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

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

There are twenty-nine drug master file entries for risperidone. Sixty-three suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: risperidone

Tradenames:3
Patents:8
Applicants:36
NDAs:48
Drug Master File Entries: see list29
Suppliers / Packaging: see list63
Therapeutic Class:Antipsychotics
Bipolar Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: risperidone

Tentative approvals for RISPERIDONE

Applicant Application No. Form Dosage
<disabled><disabled>SOLUTION; ORAL1MG/ML

Clinical Trials for: risperidone

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apotex Inc
RISPERIDONE
risperidone
TABLET;ORAL077953-002Sep 15, 2008RXNo<disabled><disabled>
Vintage
RISPERIDONE
risperidone
SOLUTION;ORAL079158-001Dec 3, 2010RXNo<disabled><disabled>
Synthon Pharms
RISPERIDONE
risperidone
TABLET;ORAL078187-004Oct 22, 2009DISCNNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: risperidone

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms
RISPERDAL
risperidone
SOLUTION;ORAL020588-001Jun 10, 19965,616,587*PED<disabled>
Janssen Pharms
RISPERDAL CONSTA
risperidone
INJECTABLE;INTRAMUSCULAR021346-002Oct 29, 20035,965,168*PED<disabled>
Janssen Pharms
RISPERDAL
risperidone
TABLET, ORALLY DISINTEGRATING;ORAL021444-004Dec 23, 20044,804,663*PED<disabled>
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Non-Orange Book Patents for Generic Ingredient: risperidone

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,799,345Preparation of injectable suspensions having improved injectability<disabled in preview>
6,110,503 Preparation of biodegradable, biocompatible microparticles containing a biologically active agent<disabled in preview>
6,495,164 Preparation of injectable suspensions having improved injectability<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: risperidone

Country Document Number Estimated Expiration
Austria308977<disabled in preview>
Japan3822909<disabled in preview>
Portugal1210942<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: RISPERIDONE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0008Belgium<disabled>PRODUCT NAME: RISPERIDONE; NAT REG.: 2 S 414 F 3 19940527; FIRST REG.: GB 0242/0186 19921208
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