Question 1

Is there a generic for Sodium nitrite; sodium thiosulfate?

Accepted Answer

The FDA Orange Book does not currently list an approved generic (ANDA) for Sodium nitrite; sodium thiosulfate. It is available as 1 brand (NDA) application.

Question 2

What is the reference-listed drug for Sodium nitrite; sodium thiosulfate?

Accepted Answer

NITHIODOTE (NDA 201444, HOPE PHARMS) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Sodium nitrite; sodium thiosulfate?

Accepted Answer

The Orange Book lists 8 patents against Sodium nitrite; sodium thiosulfate products, with the earliest listed expiry in 2030. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Question 4

What dosage forms of Sodium nitrite; sodium thiosulfate are approved?

Accepted Answer

Sodium nitrite; sodium thiosulfate is approved in the following dosage form: solution, solution.

Patent	Expires	In	Type
11753301	Feb 10, 2030	in 3 yr 8 mo	SubstanceProductU-3681
9687506	Feb 10, 2030	in 3 yr 8 mo	ProductU-3394
12304813	Feb 10, 2030	in 3 yr 8 mo	Product
9345724	Jul 07, 2030	in 4 yr 1 mo	SubstanceProductU-2015
10479686	Jul 07, 2030	in 4 yr 1 mo	ProductU-3390
9585912	Jul 07, 2030	in 4 yr 1 mo	SubstanceProduct
8496973	Mar 29, 2031	in 4 yr 10 mo	SubstanceProductU-1419
8568793	Dec 24, 2031	in 5 yr 7 mo	SubstanceProduct

Sodium nitrite; sodium thiosulfate

Brand (NDA) products · solution, solution

Listed patents (8)

Sodium nitrite; sodium thiosulfate — frequently asked questions

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