Radicava Ors is a drug owned by Mitsubishi Tanabe Pharma Corp. It is protected by 5 US drug patents filed from 2022 to 2024 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Nov 01, 2039. Details of Radicava Ors'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). | |||
| US11478450 | Edaravone suspension for oral administration |
Nov, 2039
(14 years from now) | Active |
| US10987341 | Edaravone suspension for oral administration |
Nov, 2039
(14 years from now) | Active |
| US11241416 | Edaravone suspension for oral administration |
Nov, 2039
(14 years from now) | Active |
| US11957660 | Edaravone suspension for oral administration |
Nov, 2039
(14 years from now) | Active |
| US11826352 | Edaravone suspension for oral administration |
Nov, 2039
(14 years from now) | Active |
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 Radicava Ors's patents.
Latest Legal Activities on Radicava Ors's Patents
Given below is the list of recent legal activities going on the following patents of Radicava Ors.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Recordation of Patent Grant Mailed Critical | 16 Apr, 2024 | US11957660 |
| Patent eGrant Notification | 16 Apr, 2024 | US11957660 |
| Email Notification Critical | 16 Apr, 2024 | US11957660 |
| Mail Patent eGrant Notification | 16 Apr, 2024 | US11957660 |
| Recordation of Patent eGrant | 16 Apr, 2024 | US11957660 |
| Patent Issue Date Used in PTA Calculation Critical | 16 Apr, 2024 | US11957660 |
| Email Notification Critical | 28 Mar, 2024 | US11957660 |
| Issue Notification Mailed Critical | 27 Mar, 2024 | US11957660 |
| Dispatch to FDC | 21 Mar, 2024 | US11957660 |
| Application Is Considered Ready for Issue Critical | 21 Mar, 2024 | US11957660 |
FDA has granted several exclusivities to Radicava Ors. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Radicava Ors, 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 Radicava Ors.
Exclusivity Information
Radicava Ors holds 2 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2029. Details of Radicava Ors's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | May 12, 2025 |
| Orphan Drug Exclusivity(ODE-144) | May 12, 2029 |
US patents provide insights into the exclusivity only within the United States, but Radicava Ors 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 Radicava Ors's family patents as well as insights into ongoing legal events on those patents.
Radicava Ors's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Radicava Ors's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Nov 01, 2039 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Radicava Ors Generic API suppliers:
Edaravone is the generic name for the brand Radicava Ors. 5 different companies have already filed for the generic of Radicava Ors, with Gland Pharma Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Radicava Ors's generic
How can I launch a generic of Radicava Ors before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Radicava Ors's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Radicava Ors'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 Radicava Ors -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 105 mg/5 mL | 20 Apr, 2023 | 1 | 01 Nov, 2039 |
Alternative Brands for Radicava Ors
Radicava Ors which is used for treating amyotrophic lateral sclerosis., has several other brand drugs using the same active ingredient (Edaravone). 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 | |
|---|---|---|
| Mitsubishi Tanabe |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Edaravone, Radicava Ors's active ingredient. Check the complete list of approved generic manufacturers for Radicava Ors
About Radicava Ors
Radicava Ors is a drug owned by Mitsubishi Tanabe Pharma Corp. It is used for treating amyotrophic lateral sclerosis. Radicava Ors uses Edaravone as an active ingredient. Radicava Ors was launched by Mitsubishi Tanabe in 2022.
Approval Date:
Radicava Ors was approved by FDA for market use on 12 May, 2022.
Active Ingredient:
Radicava Ors uses Edaravone as the active ingredient. Check out other Drugs and Companies using Edaravone ingredient
Treatment:
Radicava Ors is used for treating amyotrophic lateral sclerosis.
Dosage:
Radicava Ors is available in suspension form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 105MG/5ML | SUSPENSION | Prescription | ORAL |