Details for New Drug Application (NDA): 209176
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NDA 209176 describes RADICAVA, which is a drug marketed by Mitsubishi Tanabe and is included in two NDAs. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the RADICAVA profile page.
The generic ingredient in RADICAVA is edaravone. One supplier is listed for this compound. Additional details are available on the edaravone profile page.
The generic ingredient in RADICAVA is edaravone. One supplier is listed for this compound. Additional details are available on the edaravone profile page.
Summary for 209176
| Tradename: | RADICAVA |
| Applicant: | Mitsubishi Tanabe |
| Ingredient: | edaravone |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 209176
Generic Entry Date for 209176*:
Constraining patent/regulatory exclusivity:
TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS) Dosage:
SOLUTION;INTRAVENOUS |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Suppliers and Packaging for NDA: 209176
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| RADICAVA | edaravone | SOLUTION;INTRAVENOUS | 209176 | NDA | Mitsubishi Tanabe Pharma America, Inc. | 70510-2171 | 70510-2171-2 | 2 BAG in 1 CARTON (70510-2171-2) / 100 mL in 1 BAG (70510-2171-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 30MG/100ML (0.3MG/ML) | ||||
| Approval Date: | May 5, 2017 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | May 5, 2024 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS) | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 60MG/100ML (0.6MG/ML) | ||||
| Approval Date: | Nov 15, 2018 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | May 5, 2024 | ||||||||
| Regulatory Exclusivity Use: | FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S).AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S) | ||||||||
Expired US Patents for NDA 209176
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Mitsubishi Tanabe | RADICAVA | edaravone | SOLUTION;INTRAVENOUS | 209176-001 | May 5, 2017 | ⤷ Try a Trial | ⤷ Try a Trial |
| Mitsubishi Tanabe | RADICAVA | edaravone | SOLUTION;INTRAVENOUS | 209176-002 | Nov 15, 2018 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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