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NITHIODOTE

NDA

SODIUM NITRITE; SODIUM THIOSULFATE | N201444 | HOPE PHARMACEUTICALS

1 strength8 unique patents0 unique exclusivities

Patent Timeline

8 unique patents by expiration date

Active (8)Today

2027

2028

2029

2030

2031

2032

Today

Mar. 29, 2031

Dec. 24, 2031

Jul. 7, 2030

Jul. 7, 2030

Feb. 10, 2030

Jul. 7, 2030

Feb. 10, 2030

Feb. 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

1 case on OB patents (1 active) from PACER

Case	Court	Filed	Status	Judge
Hope Medical Enterprises, Inc. v. Accord Healthcare, Inc. 1:2022cv00978 4 patentsANDA 217214Sodium Thiosulfate	D. Del.	2022-07-26	Active	—

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

3 letters from Drugs@FDA

Date	Submission	Document
Jan 14, 2021	SUPPL -26	View Letter (PDF)
Oct 23, 2017	SUPPL -19	View Letter (PDF)
Jan 20, 2011	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 300MG/10ML(30MG/ML),N/A;N/A,12.5GM/50ML(250MG/ML)

RLD

8 patents0 exclusivities▴

SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS | Approved: Jan 14, 2011

Patents (8) · 6 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8496973	Mar 29, 2031	—	Yes	Yes		—
8568793	Dec 24, 2031	—	Yes	Yes	—	—
9345724	Jul 7, 2030	—	Yes	Yes		—
9585912	Jul 7, 2030	—	Yes	Yes	—	—
9687506	Feb 10, 2030	—	—	Yes		—
10479686	Jul 7, 2030	—	—	Yes		—
11753301	Feb 10, 2030	—	Yes	Yes		—
12304813	Feb 10, 2030	—	—	Yes	—	—