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Generated: December 15, 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?

Risperidone
is the generic ingredient in three branded drugs marketed by Janssen Pharms, Amneal Pharms, Ani Pharms Inc, Apotex Inc, Bio Pharm Inc, Lifestar Pharma, Precision Dose, Silarx Pharms Inc, Taro, Tris Pharma Inc, Vintage, West-ward Pharms Int, Wockhardt, Actavis Labs Fl Inc, Dr Reddys Labs Ltd, Jubilant Generics, Mylan Pharms Inc, Par Pharm, Sandoz, Sun Pharm Inds Ltd, Teva, Zydus Pharms Usa, Ajanta Pharma Ltd, Aurobindo Pharma, Cipla, Jubilant Cadista, Mylan, Oxford Pharms, Pliva Hrvatska Doo, Prinston Inc, Ratiopharm, Sun Pharm Inds Inc, Synthon Pharms, Torrent Pharms, Watson Labs, West Ward Pharms, and Zydus Pharms Usa Inc, 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.

Risperidone has one hundred and fifty-two patent family members in thirty-four countries and one supplementary protection certificate in one country.

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

Pharmacology for risperidone

Medical Subject Heading (MeSH) Categories for risperidone

Tentative approvals for RISPERIDONE

Applicant Application No. Strength Dosage Form
u► Subscribe1MG/MLSOLUTION; ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Mylan Pharms IncRISPERIDONErisperidoneTABLET, ORALLY DISINTEGRATING;ORAL091537-001Mar 30, 2011ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Jubilant GenericsRISPERIDONErisperidoneTABLET, ORALLY DISINTEGRATING;ORAL090839-004Nov 4, 2011ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Prinston IncRISPERIDONErisperidoneTABLET;ORAL077493-002Nov 29, 2011ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
CiplaRISPERIDONErisperidoneTABLET;ORAL077543-004May 18, 2011ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Aurobindo PharmaRISPERIDONErisperidoneTABLET;ORAL078269-004Oct 8, 2008ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Aurobindo PharmaRISPERIDONErisperidoneTABLET;ORAL078269-002Oct 8, 2008ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Janssen PharmsRISPERDAL CONSTArisperidoneINJECTABLE;INTRAMUSCULAR021346-001Oct 29, 2003RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Jubilant GenericsRISPERIDONErisperidoneTABLET, ORALLY DISINTEGRATING;ORAL090839-001Nov 4, 2011ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
TevaRISPERIDONErisperidoneTABLET;ORAL076228-001Jun 30, 2008ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
WockhardtRISPERIDONErisperidoneTABLET;ORAL078871-004Oct 9, 2008ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: risperidone

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen PharmsRISPERDALrisperidoneSOLUTION;ORAL020588-001Jun 10, 1996► Subscribe► Subscribe
Janssen PharmsRISPERDALrisperidoneTABLET, ORALLY DISINTEGRATING;ORAL021444-004Dec 23, 2004► Subscribe► Subscribe
Janssen PharmsRISPERDAL CONSTArisperidoneINJECTABLE;INTRAMUSCULAR021346-001Oct 29, 2003► Subscribe► Subscribe
Janssen PharmsRISPERDALrisperidoneTABLET, ORALLY DISINTEGRATING;ORAL021444-002Apr 2, 2003► Subscribe► Subscribe
Janssen PharmsRISPERDAL CONSTArisperidoneINJECTABLE;INTRAMUSCULAR021346-002Oct 29, 2003► Subscribe► Subscribe
Janssen PharmsRISPERDAL CONSTArisperidoneINJECTABLE;INTRAMUSCULAR021346-004Apr 12, 2007► Subscribe► Subscribe
Janssen PharmsRISPERDALrisperidoneTABLET;ORAL020272-007Jan 27, 1999► Subscribe► Subscribe
Janssen PharmsRISPERDALrisperidoneTABLET, ORALLY DISINTEGRATING;ORAL021444-001Apr 2, 2003► Subscribe► Subscribe
Janssen PharmsRISPERDAL CONSTArisperidoneINJECTABLE;INTRAMUSCULAR021346-003Oct 29, 2003► Subscribe► Subscribe
Janssen PharmsRISPERDALrisperidoneSOLUTION;ORAL020588-001Jun 10, 1996► Subscribe► Subscribe
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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► Subscribe
6,110,503 Preparation of biodegradable, biocompatible microparticles containing a biologically active agent► Subscribe
6,495,164 Preparation of injectable suspensions having improved injectability► Subscribe
6,290,983 Preparation of biodegradable, biocompatible microparticles containing a biologically active agent► Subscribe
7,371,406Preparation of injectable suspensions having improved injectability► Subscribe
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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
Bulgaria66023► Subscribe
World Intellectual Property Organization (WIPO)9741837► Subscribe
Slovakia154198► Subscribe
Denmark0910345► Subscribe
Spain2574823► Subscribe
China1226821► Subscribe
Russian Federation2201214► Subscribe
Czech Republic293578► Subscribe
Estonia9800383► Subscribe
Brazil0111060► Subscribe
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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► SubscribePRODUCT NAME: RISPERIDONE; NAT REG.: 2 S 414 F 3 19940527; FIRST REG.: GB 0242/0186 19921208
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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Teva
Merck
US Army
Colorcon
Federal Trade Commission
Medtronic
Baxter
Moodys
UBS

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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