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Serving leading biopharmaceutical companies globally:

Colorcon
Novartis
Argus Health
Covington
Medtronic
Queensland Health
Teva
QuintilesIMS
Citi
Cipla

Generated: January 24, 2018

DrugPatentWatch Database Preview

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.

There are thirty drug master file entries for risperidone. Sixty 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
➤ Subscribe➤ Subscribe1MG/MLSOLUTION; ORAL

US Patents and Regulatory Information for RISPERIDONE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Pharms RISPERDAL CONSTA risperidone INJECTABLE;INTRAMUSCULAR 021346-003 Oct 29, 2003 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Sun Pharm Inds Ltd RISPERIDONE risperidone TABLET, ORALLY DISINTEGRATING;ORAL 077542-002 Aug 6, 2010 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
West Ward Pharms RISPERIDONE risperidone TABLET;ORAL 078740-002 May 29, 2009 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Aurobindo Pharma RISPERIDONE risperidone TABLET;ORAL 078269-004 Oct 8, 2008 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
West Ward Pharms RISPERIDONE risperidone TABLET;ORAL 078740-005 May 29, 2009 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Janssen Pharms RISPERDAL risperidone TABLET;ORAL 020272-003 Dec 29, 1993 AB RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Prinston Inc RISPERIDONE risperidone TABLET;ORAL 078707-006 Dec 29, 2008 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
West-ward Pharms Int RISPERIDONE risperidone SOLUTION;ORAL 076904-001 Jul 29, 2009 AA RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Torrent Pharms RISPERIDONE risperidone TABLET;ORAL 079088-004 Oct 30, 2008 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Janssen Pharms RISPERDAL CONSTA risperidone INJECTABLE;INTRAMUSCULAR 021346-003 Oct 29, 2003 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for RISPERIDONE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms RISPERDAL risperidone TABLET, ORALLY DISINTEGRATING;ORAL 021444-005 Dec 23, 2004 ➤ Subscribe ➤ Subscribe
Janssen Pharms RISPERDAL risperidone TABLET, ORALLY DISINTEGRATING;ORAL 021444-003 Apr 2, 2003 ➤ Subscribe ➤ Subscribe
Janssen Pharms RISPERDAL risperidone TABLET, ORALLY DISINTEGRATING;ORAL 021444-001 Apr 2, 2003 ➤ Subscribe ➤ Subscribe
Janssen Pharms RISPERDAL CONSTA risperidone INJECTABLE;INTRAMUSCULAR 021346-001 Oct 29, 2003 ➤ Subscribe ➤ Subscribe
Janssen Pharms RISPERDAL risperidone TABLET, ORALLY DISINTEGRATING;ORAL 021444-002 Apr 2, 2003 ➤ Subscribe ➤ Subscribe
Janssen Pharms RISPERDAL CONSTA risperidone INJECTABLE;INTRAMUSCULAR 021346-001 Oct 29, 2003 ➤ Subscribe ➤ Subscribe
Janssen Pharms RISPERDAL CONSTA risperidone INJECTABLE;INTRAMUSCULAR 021346-004 Apr 12, 2007 ➤ Subscribe ➤ Subscribe
Janssen Pharms RISPERDAL CONSTA risperidone INJECTABLE;INTRAMUSCULAR 021346-002 Oct 29, 2003 ➤ Subscribe ➤ Subscribe
Janssen Pharms RISPERDAL risperidone TABLET, ORALLY DISINTEGRATING;ORAL 021444-005 Dec 23, 2004 ➤ Subscribe ➤ Subscribe
Janssen Pharms RISPERDAL CONSTA risperidone INJECTABLE;INTRAMUSCULAR 021346-003 Oct 29, 2003 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for 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
6,110,503 Preparation of biodegradable, biocompatible microparticles containing a biologically active agent ➤ Subscribe
7,799,345 Preparation of injectable suspensions having improved injectability ➤ 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
7,371,406 Preparation of injectable suspensions having improved injectability ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for RISPERIDONE

Supplementary Protection Certificates for RISPERIDONE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0008 Belgium ➤ Subscribe PRODUCT NAME: RISPERIDONE; NAT REG.: 2 S 414 F 3 19940527; FIRST REG.: GB 0242/0186 19921208
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

Dow
Boehringer Ingelheim
Moodys
Fish and Richardson
McKesson
UBS
Argus Health
Cipla
Daiichi Sankyo

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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