Details for New Drug Application (NDA): 219884
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NDA 219884 describes DAYBUE STIX, which is a drug marketed by Acadia Pharms Inc and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the DAYBUE STIX profile page.
The generic ingredient in DAYBUE STIX is trofinetide. One supplier is listed for this compound. Additional details are available on the trofinetide profile page.
The generic ingredient in DAYBUE STIX is trofinetide. One supplier is listed for this compound. Additional details are available on the trofinetide profile page.
Summary for 219884
| Tradename: | DAYBUE STIX |
| Applicant: | Acadia Pharms Inc |
| Ingredient: | trofinetide |
| Patents: | 4 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 219884
Generic Entry Date for 219884*:
Constraining patent/regulatory exclusivity:
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) 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: 219884
Suppliers and Packaging for NDA: 219884
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DAYBUE STIX | trofinetide | FOR SOLUTION;ORAL | 219884 | NDA | Acadia Pharmaceuticals Inc. | 63090-663 | 63090-663-60 | 60 PACKET in 1 CARTON (63090-663-60) / 1 FOR SOLUTION in 1 PACKET (63090-663-01) |
| DAYBUE STIX | trofinetide | FOR SOLUTION;ORAL | 219884 | NDA | Acadia Pharmaceuticals Inc. | 63090-664 | 63090-664-60 | 60 PACKET in 1 CARTON (63090-664-60) / 1 FOR SOLUTION in 1 PACKET (63090-664-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SOLUTION;ORAL | Strength | 5000MG/PACKET | ||||
| Approval Date: | Dec 11, 2025 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Mar 10, 2030 | ||||||||
| 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) | ||||||||
| Regulatory Exclusivity Expiration: | Mar 10, 2028 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | 11,370,755 | Patent Expiration: | Aug 3, 2040 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
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