Details for New Drug Application (NDA): 219285
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NDA 219285 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 219285
| Tradename: | EVRYSDI |
| Applicant: | Genentech Inc |
| Ingredient: | risdiplam |
| Patents: | 6 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 219285
Generic Entry Date for 219285*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;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: 219285
Suppliers and Packaging for NDA: 219285
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| EVRYSDI | risdiplam | TABLET;ORAL | 219285 | NDA | Genentech, Inc. | 50242-202 | 50242-202-01 | 1 BOTTLE, PLASTIC in 1 CARTON (50242-202-01) / 30 TABLET in 1 BOTTLE, PLASTIC |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Feb 11, 2025 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Oct 3, 2026 | ||||||||
| Regulatory Exclusivity Use: | INFORMATION ADDED TO CLINICAL PHARMACOLOGY SECTION | ||||||||
| Patent: | 11,534,444 | Patent Expiration: | Oct 4, 2038 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF SPINAL MUSCULAR ATROPHY | ||||||||
| Patent: | 11,827,646 | Patent Expiration: | Jan 25, 2036 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF SPINAL MUSCULAR ATROPHY | ||||||||
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