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DAYBUE

NDA

TROFINETIDE | N217026 | ACADIA PHARMACEUTICALS INC

1 strength4 unique patents3 unique exclusivities

Patent Timeline

4 unique patents, 2 exclusivities by expiration date

Active (4)TodayPED (+6 mo)Exclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

2040

2041

2042

2043

Today

Jul. 27, 2032

Feb. 3, 2041

Jan. 12, 2043

Jan. 12, 2043

NCE

Sep. 10, 2030

ODE-425

Sep. 10, 2030

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Daybue (2023)

Total Spending

$19.2M

Total Claims

320

Beneficiaries

Avg Cost/Unit

$21.91

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Mar 31, 2026	SUPPL -8	View Letter (PDF)
Aug 6, 2025	SUPPL -6	View Letter (PDF)
Aug 6, 2025	SUPPL -7	View Letter (PDF)
Oct 3, 2024	SUPPL -1	View Letter (PDF)
Oct 2, 2024	SUPPL -3	View Letter (PDF)
Mar 30, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 200MG/ML

RLD

4 patents3 exclusivities▴

SOLUTION;ORAL | Approved: Mar 10, 2023

Patents (4)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
9212204	Jan 27, 2032PED: Jul 27, 2032	PED	—	—		—
11370755	Aug 3, 2040PED: Feb 3, 2041	PED	Yes	Yes	—	—
11827600	Jul 12, 2042PED: Jan 12, 2043	PED	Yes	Yes		—
12492167	Jul 12, 2042PED: Jan 12, 2043	PED	Yes	Yes		—

Exclusivities (3)

Code	Date	Status
NCE	Mar 10, 2028	Active
ODE-425	Mar 10, 2030	Active
PED	Sep 10, 2030	Active