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CRENESSITY

NDA

CRINECERFONT | N218808 | NEUROCRINE BIOSCIENCES INC

3 strengths5 unique patents2 unique exclusivities

Patent Timeline

5 unique patents, 2 exclusivities by expiration date

Active (5)TodayExclusivity

2026

2027

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2029

2030

2031

2032

2033

2034

2035

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2038

2039

2040

2041

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2043

Today

Jan. 21, 2035

Jan. 21, 2035

Jan. 21, 2035

Jun. 9, 2041

Jan. 12, 2043

NCE

Dec. 13, 2029

ODE-503

Dec. 13, 2031

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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Neurocrine Biosciences, Inc. v. Spruce Biosciences, Inc. 1:2025cv00059 4 patentscrinecerfont	D. Del.	2025-01-14	Terminated 2025-06-09	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Dec 16, 2024	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 25MG

RLD

5 patents2 exclusivities▴

CAPSULE;ORAL | Approved: Dec 13, 2024

Patents (5)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
10905690	Jan 21, 2035	—	—	—		—
11311544	Jan 21, 2035	—	—	—		—
11730739	Jan 21, 2035	—	—	—		—
12128033	Jun 9, 2041	—	Yes	—		—
12582634	Jan 12, 2043	—	Yes	—	—	—

Exclusivities (2)

Code	Date	Status
NCE	Dec 13, 2029	Active
ODE-503	Dec 13, 2031	Active

#002 — 50MG

RLD

5 patents2 exclusivities▾

CAPSULE;ORAL | Approved: Dec 13, 2024

#003 — 100MG

RLD

5 patents2 exclusivities▾

CAPSULE;ORAL | Approved: Dec 13, 2024