Details for New Drug Application (NDA): 213535
✉ Email this page to a colleague
The generic ingredient in EVRYSDI is risdiplam. One supplier is listed for this compound. Additional details are available on the risdiplam profile page.
Summary for 213535
Tradename: | EVRYSDI |
Applicant: | Genentech Inc |
Ingredient: | risdiplam |
Patents: | 5 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 213535
Generic Entry Date for 213535*:
Constraining patent/regulatory exclusivity:
Dosage:
FOR SOLUTION;ORAL |
*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.
Pharmacology for NDA: 213535
Suppliers and Packaging for NDA: 213535
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
EVRYSDI | risdiplam | FOR SOLUTION;ORAL | 213535 | NDA | Genentech Inc. | 50242-175 | 50242-175-07 | 1 BOTTLE, GLASS in 1 CARTON (50242-175-07) / 80 mL in 1 BOTTLE, GLASS |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SOLUTION;ORAL | Strength | 0.75MG/ML | ||||
Approval Date: | Aug 7, 2020 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Oct 3, 2026 | ||||||||
Regulatory Exclusivity Use: | INFORMATION ADDED TO CLINICAL PHARMACOLOGY SECTION | ||||||||
Regulatory Exclusivity Expiration: | Aug 7, 2025 | ||||||||
Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
Regulatory Exclusivity Expiration: | May 27, 2025 | ||||||||
Regulatory Exclusivity Use: | NEW PATIENT POPULATION |
Complete Access Available with Subscription