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CRENESSITY

NDA

CRINECERFONT | N218820 | NEUROCRINE BIOSCIENCES INC

1 strength5 unique patents2 unique exclusivities

Patent Timeline

5 unique patents, 2 exclusivities by expiration date

Active (5)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

2040

2041

2042

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

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

Approval Letters

1 letter from Drugs@FDA

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

Source: Drugs@FDA application documents.

Products (1)

#001 — 50MG/ML

RLD

5 patents2 exclusivities▴

SOLUTION;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