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
(5 years ago) |
Expired
|
|
US6596316 (Pediatric) | Preparation of microparticles having a selected release profile |
Jun, 2019
(6 years ago) |
Expired
|
|
US6379703 (Pediatric) | Preparation of microparticles having a selected release profile |
Jun, 2019
(6 years ago) |
Expired
|
|
US6194006 (Pediatric) | Preparation of microparticles having a selected release profile |
Jun, 2019
(6 years ago) |
Expired
|
| US6194006 | Preparation of microparticles having a selected release profile |
Dec, 2018
(6 years ago) |
Expired
|
| US6379703 | Preparation of microparticles having a selected release profile |
Dec, 2018
(6 years ago) |
Expired
|
| US6596316 | Preparation of microparticles having a selected release profile |
Dec, 2018
(6 years ago) |
Expired
|
|
US5792477 (Pediatric) | Preparation of extended shelf-life biodegradable, biocompatible microparticles containing a biologically active agent |
Nov, 2017
(8 years ago) |
Expired
|
|
US5916598 (Pediatric) | Preparation of biodegradable, biocompatible microparticles containing a biologically active agent |
Nov, 2017
(8 years ago) |
Expired
|
|
US6403114 (Pediatric) | Preparation of biodegradable, biocompatible microparticles containing a biologically active agent |
Nov, 2017
(8 years ago) |
Expired
|
| US5916598 | Preparation of biodegradable, biocompatible microparticles containing a biologically active agent |
May, 2017
(8 years ago) |
Expired
|
| US6403114 | Preparation of biodegradable, biocompatible microparticles containing a biologically active agent |
May, 2017
(8 years ago) |
Expired
|
| US5792477 | Preparation of extended shelf-life biodegradable, biocompatible microparticles containing a biologically active agent |
May, 2017
(8 years ago) |
Expired
|
|
US5688801 (Pediatric) | Method of inhibiting neurotransmitter activity using microencapsulated 3-piperidiny2-substituted 1,2-benzisoxazoles and 1,2-benzisothiazoles |
May, 2015
(10 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
(11 years ago) |
Expired
|
|
US6110921 (Pediatric) | Microencapsulated 3-piperidinyl-substituted 1,2-benzisoxazoles and 1,2-benzisothiazoles |
May, 2014
(11 years ago) |
Expired
|
|
US6368632 (Pediatric) | Microencapsulated 3-piperidinyl-substituted 1,2-benzisoxazoles and 1,2-benzisothiazoles |
May, 2014
(11 years ago) |
Expired
|
|
US5965168 (Pediatric) | Microencapsulated 3-piperidinyl-substituted 1,2-benzisoxazoles and 1,2-benzisothiazoles |
May, 2014
(11 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.
Latest 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 |
|---|---|---|
 | ||
| Expire Patent
Critical | 17 Jul, 2017 | US7547452 |
| Recordation of Patent Grant Mailed
Critical | 16 Jun, 2009 | US7547452 |
| Patent Issue Date Used in PTA Calculation
Critical | 16 Jun, 2009 | US7547452 |
| Issue Notification Mailed
Critical | 27 May, 2009 | US7547452 |
| Dispatch to FDC | 20 May, 2009 | US7547452 |
| Application Is Considered Ready for Issue
Critical | 12 May, 2009 | US7547452 |
| Issue Fee Payment Received
Critical | 11 May, 2009 | US7547452 |
| Issue Fee Payment Verified
Critical | 11 May, 2009 | US7547452 |
| Mail Notice of Allowance
Critical | 03 Apr, 2009 | US7547452 |
| Case Docketed to Examiner in GAU
Critical | 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.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US6667061 | May, 2016 |
Final Written Decision
(28 Nov, 2017) | Alkermes Controlled Therapeutics, Inc. et al. | Luye Pharma Group Ltd. et al. |
| US6667061 | May, 2016 |
FWD Entered
(28 Nov, 2017) | Alkermes Controlled Therapeutics, Inc. | Luye Pharma Group Ltd. |
| US6667061 | May, 2016 |
Institution Denied
(30 Nov, 2016) | Alkermes Controlled Therapeutics, Inc. et al. | Luye Pharma Group Ltd. et al. |
| 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 |
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
Explore Our Curated Drug Screens
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. 41 different companies have already filed for the generic of Risperdal Consta, with Dash Pharms 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 |
| |||||||||
| Indivior |
| |||||||||
| Intra-cellular |
| |||||||||
| Janssen Pharms |
| |||||||||
| Otsuka |
| |||||||||
| Otsuka Pharm Co Ltd |
| |||||||||
| Sunovion Pharms Inc |
| |||||||||
| Teva |
| |||||||||
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.
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 |