Details for New Drug Application (NDA): 217026
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NDA 217026 describes DAYBUE, which is a drug marketed by Acadia Pharms Inc and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the DAYBUE profile page.
The generic ingredient in DAYBUE is trofinetide. One supplier is listed for this compound. Additional details are available on the trofinetide profile page.
The generic ingredient in DAYBUE is trofinetide. One supplier is listed for this compound. Additional details are available on the trofinetide profile page.
Summary for 217026
| Tradename: | DAYBUE |
| Applicant: | Acadia Pharms Inc |
| Ingredient: | trofinetide |
| Patents: | 3 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 217026
Generic Entry Date for 217026*:
Constraining patent/regulatory exclusivity:
TREATMENT OF RETT SYNDROME IN ADULTS AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER Dosage:
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.
Suppliers and Packaging for NDA: 217026
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DAYBUE | trofinetide | SOLUTION;ORAL | 217026 | NDA | Acadia Pharmaceuticals Inc. | 63090-660 | 63090-660-01 | 1 BOTTLE, PLASTIC in 1 CARTON (63090-660-01) / 450 mL in 1 BOTTLE, PLASTIC |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 200MG/ML | ||||
| Approval Date: | Mar 10, 2023 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Mar 10, 2028 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Regulatory Exclusivity Expiration: | Mar 10, 2030 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF RETT SYNDROME IN ADULTS AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER | ||||||||
| Patent: | ⤷ Subscribe | Patent Expiration: | Aug 3, 2040 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
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