Risperdal is a drug owned by Janssen Pharmaceuticals Inc. It is protected by 8 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 Dec 10, 2017. Details of Risperdal'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). | |||
|
US6224905 (Pediatric) | Biconvex rapidly disintegrating dosage forms |
Dec, 2017
(7 years ago) |
Expired
|
| US6224905 | Biconvex rapidly disintegrating dosage forms |
Jun, 2017
(7 years ago) |
Expired
|
|
US5648093 (Pediatric) | Pharmaceutical and other dosage forms |
Jan, 2015
(9 years ago) |
Expired
|
|
US5453425 (Pediatric) | Risperidone oral formulation |
Jan, 2015
(9 years ago) |
Expired
|
|
USRE39181 (Pediatric) | Aqueous risperidone formulations |
Jan, 2015
(9 years ago) |
Expired
|
| US5648093 | Pharmaceutical and other dosage forms |
Jul, 2014
(10 years ago) |
Expired
|
| USRE39181 | Aqueous risperidone formulations |
Jul, 2014
(10 years ago) |
Expired
|
| US5453425 | Risperidone oral formulation |
Jul, 2014
(10 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Risperdal 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's family patents as well as insights into ongoing legal events on those patents.
Risperdal's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Risperdal's generic launch date based on the expiry of its last outstanding patent is estimated to be Dec 10, 2017 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Risperdal Generic API suppliers:
Risperidone is the generic name for the brand Risperdal. 39 different companies have already filed for the generic of Risperdal, 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's generic
How can I launch a generic of Risperdal before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Risperdal's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Risperdal's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Risperdal -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 1 mg/mL | |||||
| 0.25 mg, 1 mg, 2 mg, 3 mg and 4 mg | |||||
| 0.25 mg | 11 Apr, 2005 | 1 | 30 Apr, 2009 | 10 Jun, 2017 | Eligible |
| 0.5 mg, 1 mg and 2 mg | |||||
| 3 mg and 4 mg | 23 Mar, 2005 | 1 | 30 Apr, 2009 | 10 Jun, 2017 | Eligible |
Alternative Brands for Risperdal
Risperdal which is used for treating various conditions such as depression, anxiety, and obsessive-compulsive disorder., has several other brand drugs 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 | |
|---|---|---|
| Indivior |
| |
| Janssen Pharms |
| |
| Labs Farms Rovi Sa |
| |
| Shandong Luye |
| |
| Teva |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Risperidone, Risperdal's active ingredient. Check the complete list of approved generic manufacturers for Risperdal
About Risperdal
Risperdal is a drug owned by Janssen Pharmaceuticals Inc. It is used for treating various conditions such as depression, anxiety, and obsessive-compulsive disorder. Risperdal uses Risperidone as an active ingredient. Risperdal was launched by Janssen Pharms in 2003.
Approval Date:
Risperdal was approved by FDA for market use on 02 April, 2003.
Active Ingredient:
Risperdal uses Risperidone as the active ingredient. Check out other Drugs and Companies using Risperidone ingredient
Treatment:
Risperdal is used for treating various conditions such as depression, anxiety, and obsessive-compulsive disorder.
Dosage:
Risperdal is available in the following dosage forms - solution form for oral use, tablet, orally disintegrating form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING | Discontinued | ORAL |
| 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING | Discontinued | ORAL |
| 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING | Discontinued | ORAL |
| 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING | Discontinued | ORAL |
| 3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING | Discontinued | ORAL |
| 1MG/ML | SOLUTION | Prescription | ORAL |