Radicava is a drug owned by Mitsubishi Tanabe Pharma Corp. It is protected by 1 US drug patent filed in 2018 out of which all have expired. Radicava's patents have been open to challenges since 05 May, 2021. Based on its patents and exclusivities, its generic launch date is estimated to be May 05, 2024. Details of Radicava'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). | |||
| US6933310 | Therapeutic agent for amyotrophic lateral sclerosis (ALS) |
Nov, 2020
(4 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 Radicava's patents.
Latest Legal Activities on Radicava's Patents
Given below is the list of recent legal activities going on the following patents of Radicava.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Recordation of Patent Grant Mailed
Critical | 23 Aug, 2005 | US6933310 |
| Patent Issue Date Used in PTA Calculation
Critical | 23 Aug, 2005 | US6933310 |
| Issue Notification Mailed
Critical | 03 Aug, 2005 | US6933310 |
| Dispatch to FDC | 29 Jun, 2005 | US6933310 |
| Application Is Considered Ready for Issue
Critical | 23 Jun, 2005 | US6933310 |
| Issue Fee Payment Received
Critical | 07 Jun, 2005 | US6933310 |
| Issue Fee Payment Verified
Critical | 07 Jun, 2005 | US6933310 |
| Mail Notice of Allowance
Critical | 24 Mar, 2005 | US6933310 |
| Notice of Allowance Data Verification Completed
Critical | 23 Mar, 2005 | US6933310 |
| Miscellaneous Incoming Letter | 14 Dec, 2004 | US6933310 |
FDA has granted several exclusivities to Radicava. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Radicava, 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.
Exclusivity Information
Radicava holds 4 exclusivities. All of its exclusivities have expired in 2024. Details of Radicava's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | May 05, 2022 |
| Orphan Drug Exclusivity(ODE) | May 05, 2024 |
| ODE*(ODE*) | May 05, 2024 |
| Orphan Drug Exclusivity(ODE-144) | May 05, 2024 |
US patents provide insights into the exclusivity only within the United States, but
Radicava 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's family patents as well as insights into
ongoing legal events
on those patents.
Radicava's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Radicava's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 05, 2024 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Radicava Generic API suppliers:
Edaravone is the generic name for the brand Radicava. 6 different companies have already filed for the generic of Radicava, with Gland having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Radicava's generic
Alternative Brands for Radicava
Radicava which is used for the treatment of amyotrophic lateral sclerosis (ALS)., 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 | |
|---|---|---|
| Kk Bcj-94 |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Edaravone, Radicava's active ingredient. Check the complete list of approved generic manufacturers for Radicava
About Radicava
Radicava is a drug owned by Mitsubishi Tanabe Pharma Corp. It is used for the treatment of amyotrophic lateral sclerosis (ALS). Radicava uses Edaravone as an active ingredient. Radicava was launched by Mitsubishi Tanabe in 2017.
Approval Date:
Radicava was approved by FDA for market use on 05 May, 2017.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Radicava is 05 May, 2017, its NCE-1 date is estimated to be 05 May, 2021.
Active Ingredient:
Radicava uses Edaravone as the active ingredient. Check out other Drugs and Companies using Edaravone ingredient
Treatment:
Radicava is used for the treatment of amyotrophic lateral sclerosis (ALS).
Dosage:
Radicava is available in solution form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 30MG/100ML (0.3MG/ML) | SOLUTION | Prescription | INTRAVENOUS |
| 60MG/100ML (0.6MG/ML) | SOLUTION | Prescription | INTRAVENOUS |