Details for New Drug Application (NDA): 213535
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NDA 213535 describes EVRYSDI, which is a drug marketed by Genentech Inc and is included in two NDAs. It is available from one supplier. There are seven patents protecting this drug. Additional details are available on the EVRYSDI profile page.
The generic ingredient in EVRYSDI is risdiplam. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the risdiplam profile page.
The generic ingredient in EVRYSDI is risdiplam. There is one drug master file entry for this compound. 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: | 7 |
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, 2027 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF SPINAL MUSCULAR ATROPHY (SMA) IN PATIENTS 2 MONTHS OF AGE AND OLDER | ||||||||
| Regulatory Exclusivity Expiration: | May 27, 2029 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF SPINAL MUSCULAR ATROPHY (SMA) IN PEDIATRIC PATIENTS BETWEEN BIRTH AND 2 MONTHS OF AGE | ||||||||
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