Risperdal Consta Patent Expiration

Risperdal Consta is a drug owned by Janssen Pharmaceuticals Inc. It is protected by 24 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Nov 25, 2020. Details of Risperdal Consta's patents and their expiration are given in the table below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US6667061

(Pediatric)

Preparation of injectable suspensions having improved injectability
Nov, 2020

(4 years ago)

Expired
US6667061 Preparation of injectable suspensions having improved injectability
May, 2020

(4 years ago)

Expired
US6596316

(Pediatric)

Preparation of microparticles having a selected release profile
Jun, 2019

(5 years ago)

Expired
US6379703

(Pediatric)

Preparation of microparticles having a selected release profile
Jun, 2019

(5 years ago)

Expired
US6194006

(Pediatric)

Preparation of microparticles having a selected release profile
Jun, 2019

(5 years ago)

Expired
US6194006 Preparation of microparticles having a selected release profile
Dec, 2018

(5 years ago)

Expired
US6379703 Preparation of microparticles having a selected release profile
Dec, 2018

(5 years ago)

Expired
US6596316 Preparation of microparticles having a selected release profile
Dec, 2018

(5 years ago)

Expired
US5792477

(Pediatric)

Preparation of extended shelf-life biodegradable, biocompatible microparticles containing a biologically active agent
Nov, 2017

(7 years ago)

Expired
US5916598

(Pediatric)

Preparation of biodegradable, biocompatible microparticles containing a biologically active agent
Nov, 2017

(7 years ago)

Expired
US6403114

(Pediatric)

Preparation of biodegradable, biocompatible microparticles containing a biologically active agent
Nov, 2017

(7 years ago)

Expired
US5916598 Preparation of biodegradable, biocompatible microparticles containing a biologically active agent
May, 2017

(7 years ago)

Expired
US6403114 Preparation of biodegradable, biocompatible microparticles containing a biologically active agent
May, 2017

(7 years ago)

Expired
US5792477 Preparation of extended shelf-life biodegradable, biocompatible microparticles containing a biologically active agent
May, 2017

(7 years ago)

Expired
US5688801

(Pediatric)

Method of inhibiting neurotransmitter activity using microencapsulated 3-piperidiny2-substituted 1,2-benzisoxazoles and 1,2-benzisothiazoles
May, 2015

(9 years ago)

Expired
US5688801 Method of inhibiting neurotransmitter activity using microencapsulated 3-piperidiny2-substituted 1,2-benzisoxazoles and 1,2-benzisothiazoles
Nov, 2014

(10 years ago)

Expired
US7547452

(Pediatric)

Microencapsulated 3-piperidinyl-substituted 1,2-benzisoxazoles and 1,2-benzisothiazoles
May, 2014

(10 years ago)

Expired
US6110921

(Pediatric)

Microencapsulated 3-piperidinyl-substituted 1,2-benzisoxazoles and 1,2-benzisothiazoles
May, 2014

(10 years ago)

Expired
US6368632

(Pediatric)

Microencapsulated 3-piperidinyl-substituted 1,2-benzisoxazoles and 1,2-benzisothiazoles
May, 2014

(10 years ago)

Expired
US5965168

(Pediatric)

Microencapsulated 3-piperidinyl-substituted 1,2-benzisoxazoles and 1,2-benzisothiazoles
May, 2014

(10 years ago)

Expired
US5965168 Microencapsulated 3-piperidinyl-substituted 1,2-benzisoxazoles and 1,2-benzisothiazoles
Nov, 2013

(11 years ago)

Expired
US7547452 Microencapsulated 3-piperidinyl-substituted 1,2-benzisoxazoles and 1,2-benzisothiazoles
Nov, 2013

(11 years ago)

Expired
US6110921 Microencapsulated 3-piperidinyl-substituted 1,2-benzisoxazoles and 1,2-benzisothiazoles
Nov, 2013

(11 years ago)

Expired
US6368632 Microencapsulated 3-piperidinyl-substituted 1,2-benzisoxazoles and 1,2-benzisothiazoles
Nov, 2013

(11 years ago)

Expired


A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Risperdal Consta's patents.

Given below is the list of recent legal activities going on the following patents of Risperdal Consta.

Activity Date Patent Number
Patent litigations
Expire Patent 17 Jul, 2017 US7547452
Recordation of Patent Grant Mailed 16 Jun, 2009 US7547452
Patent Issue Date Used in PTA Calculation 16 Jun, 2009 US7547452
Issue Notification Mailed 27 May, 2009 US7547452
Dispatch to FDC 20 May, 2009 US7547452
Application Is Considered Ready for Issue 12 May, 2009 US7547452
Issue Fee Payment Received 11 May, 2009 US7547452
Issue Fee Payment Verified 11 May, 2009 US7547452
Mail Notice of Allowance 03 Apr, 2009 US7547452
Case Docketed to Examiner in GAU 18 Mar, 2009 US7547452


While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Risperdal Consta and ongoing litigations to help you estimate the early arrival of Risperdal Consta generic.

Risperdal Consta's Litigations

Risperdal Consta been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on May 31, 2016, against patent number US6667061. The petitioner Luye Pharma Group Ltd., challenged the validity of this patent, with Alkermes Controlled Therapeutics, Inc. as the respondent. Click below to track the latest information on how companies are challenging Risperdal Consta's patents.

Last updated on December 10, 2024
Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US6667061 May, 2016 FWD Entered
(28 Nov, 2017)
Alkermes Controlled Therapeutics, Inc. Luye Pharma Group Ltd.
US6667061 May, 2016 Terminated-Denied
(30 Nov, 2016)
Alkermes Controlled Therapeutics, Inc. Luye Pharma Group Ltd.


FDA has granted some exclusivities to Risperdal Consta. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Risperdal Consta, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Risperdal Consta.

Exclusivity Information

Risperdal Consta holds 2 exclusivities. All of its exclusivities have expired in 2012. Details of Risperdal Consta's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Indication(I-596) May 15, 2012
New Indication(I-597) May 15, 2012

Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years.

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US patents provide insights into the exclusivity only within the United States, but Risperdal Consta is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Risperdal Consta's family patents as well as insights into ongoing legal events on those patents.

Risperdal Consta's Family Patents


Family Patents

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Generic Launch

Generic Release Date:

Risperdal Consta's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Nov 25, 2020 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Risperdal Consta Generic API suppliers:

Risperidone is the generic name for the brand Risperdal Consta. 39 different companies have already filed for the generic of Risperdal Consta, with Heritage Pharma Avet having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Risperdal Consta's generic

Alternative Brands for Risperdal Consta

Risperdal Consta which is used for maintenance treatment of bipolar I disorder and treatment of schizophrenia., has several other brand drugs in the same treatment category and using the same active ingredient (Risperidone). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.

Drug Owner Drug Name Treatment Area
Alkermes Inc
Aristada Used for managing symptoms of schizophrenia through various methods of administration.
Aristada Initio Kit Used for managing symptoms of schizophrenia.
Indivior
Perseris Kit

(uses Risperidone)

Used for treating schizophrenia.
Intra-cellular
Caplyta Used for treating schizophrenia, bipolar depression, and bipolar disorder by modulating serotonin and dopamine receptor activity.
Janssen Pharms
Invega Trinza used for managing symptoms of schizophrenia in patients who have missed doses or need to restart treatment.
Invega Sustenna used for treating schizophrenia and schizoaffective disorder.
Otsuka
Abilify Used for treating manic episodes in bipolar disorder, major depressive disorder, irritability in autistic disorder, and maintaining stability in schizophrenia.
Rexulti used for treating major depressive disorder (MDD) and schizophrenia in adults and pediatric patients ages 13 years and older.
Abilify Asimtufii Used for managing symptoms of bipolar I disorder and schizophrenia with extended-release injectable suspension.
Abilify Mycite Kit used for acute treatment of manic and mixed episodes associated with bipolar I disorder, adjunctive treatment of major depressive disorder (MDD), and treatment of schizophrenia.
Otsuka Pharm Co Ltd
Abilify Maintena Kit Used for treating bipolar 1 disorder and schizophrenia, including during acute episodes.
Sunovion Pharms Inc
Latuda used for treating bipolar depression, major depressive episodes, and schizophrenia with improvement in attention function, negative symptoms, and cognitive dysfunction.
Teva
Uzedy

(uses Risperidone)

Used for managing symptoms of schizophrenia.

Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Risperidone. Given below is the list of those drugs and companies owning them.

Drug Owner Drug Name
Janssen Pharms
Risperdal
Labs Farms Rovi Sa
Risvan
Shandong Luye
Rykindo


Apart from brand drugs containing the same ingredient, some generics have also been filed for Risperidone, Risperdal Consta's active ingredient. Check the complete list of approved generic manufacturers for Risperdal Consta





About Risperdal Consta

Risperdal Consta is a drug owned by Janssen Pharmaceuticals Inc. It is used for maintenance treatment of bipolar I disorder and treatment of schizophrenia. Risperdal Consta uses Risperidone as an active ingredient. Risperdal Consta was launched by Janssen Pharms in 2007.

Approval Date:

Risperdal Consta was approved by FDA for market use on 12 April, 2007.

Active Ingredient:

Risperdal Consta uses Risperidone as the active ingredient. Check out other Drugs and Companies using Risperidone ingredient

Treatment:

Risperdal Consta is used for maintenance treatment of bipolar I disorder and treatment of schizophrenia.

Dosage:

Risperdal Consta is available in injectable form for intramuscular use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
37.5MG/VIAL INJECTABLE Prescription INTRAMUSCULAR
25MG/VIAL INJECTABLE Prescription INTRAMUSCULAR
50MG/VIAL INJECTABLE Prescription INTRAMUSCULAR
12.5MG/VIAL INJECTABLE Prescription INTRAMUSCULAR