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NDA

COPPER CU-64 DOTATATE | N213227 | CURIUM US LLC

1 strength4 unique patents1 unique exclusivity

Patent Timeline

4 unique patents, 1 exclusivity by expiration date

Active (4)TodayExclusivity

2026

2027

2028

2029

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2032

2033

2034

2035

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2042

Today

Aug. 23, 2032

Jul. 2, 2033

Aug. 23, 2032

Sep. 3, 2041

ODE-317

Sep. 3, 2027

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

2 letters from Drugs@FDA

Date	Submission	Document
Dec 27, 2021	SUPPL -1	View Letter (PDF)
Sep 4, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 4mL (1mCi/ML)

RLD

4 patents1 exclusivity▴

SOLUTION;INTRAVENOUS | Approved: Sep 3, 2020

Patents (4)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
10159759	Aug 23, 2032	—	—	—		—
10383961	Jul 2, 2033	—	—	—		—
11160888	Aug 23, 2032	—	—	—		—
12102696	Sep 3, 2041	—	—	Yes	—	—

Exclusivities (1)

Code	Date	Status
ODE-317	Sep 3, 2027	Active