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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
Drug Prices:see low prices

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
Par Pharm
RISPERIDONE
risperidone
TABLET, ORALLY DISINTEGRATING;ORAL077494-003Oct 26, 2009RXNo
Janssen Pharms
RISPERDAL CONSTA
risperidone
INJECTABLE;INTRAMUSCULAR021346-002Oct 29, 2003RXNo6,379,703*PEDJun 30, 2019Y
Cipla
RISPERIDONE
risperidone
TABLET;ORAL077543-006May 18, 2011RXNo
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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 CONSTA
risperidone
INJECTABLE;INTRAMUSCULAR021346-003Oct 29, 20034,804,663*PED<disabled>
Janssen Pharms
RISPERDAL
risperidone
TABLET;ORAL020272-005Dec 29, 19935,158,952*PED<disabled>
Janssen Pharms
RISPERDAL CONSTA
risperidone
INJECTABLE;INTRAMUSCULAR021346-003Oct 29, 20035,688,801*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>
6,290,983 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
Slovakia173798<disabled in preview>
Brazil0111060<disabled in preview>
Canada2406536<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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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