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Last Updated: April 24, 2024

SODIUM NITRITE - Generic Drug Details

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What are the generic sources for sodium nitrite and what is the scope of freedom to operate?

Sodium nitrite is the generic ingredient in two branded drugs marketed by Hope Pharms and is included in two NDAs. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Sodium nitrite has twenty-seven patent family members in fourteen countries.

There is one drug master file entry for sodium nitrite. One supplier is listed for this compound.

Summary for SODIUM NITRITE

International Patents:	27
US Patents:	7
Tradenames:	2
Applicants:	1
NDAs:	2
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	123
Clinical Trials:	58
Patent Applications:	2,128
Formulation / Manufacturing:	see details
What excipients (inactive ingredients) are in SODIUM NITRITE?	SODIUM NITRITE excipients list
DailyMed Link:	SODIUM NITRITE at DailyMed

Recent Clinical Trials for SODIUM NITRITE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Alabama at Birmingham	Early Phase 1
University of Alabama at Birmingham	Phase 1
National Institutes of Health (NIH)	Phase 1

See all SODIUM NITRITE clinical trials

Medical Subject Heading (MeSH) Categories for SODIUM NITRITE

Food Preservatives
Indicators and Reagents

US Patents and Regulatory Information for SODIUM NITRITE

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hope Pharms	NITHIODOTE	sodium nitrite; sodium thiosulfate	SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS	201444-001	Jan 14, 2011		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Hope Pharms	NITHIODOTE	sodium nitrite; sodium thiosulfate	SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS	201444-001	Jan 14, 2011		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y	Y		⤷ Try a Trial
Hope Pharms	NITHIODOTE	sodium nitrite; sodium thiosulfate	SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS	201444-001	Jan 14, 2011		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y	Y		⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for SODIUM NITRITE

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Country	Patent Number	Title	Estimated Expiration
Slovenia	2395834		⤷ Try a Trial
Lithuania	3569237		⤷ Try a Trial
Denmark	2395834		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for SODIUM NITRITE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2563920	CR 2019 00001	Denmark	⤷ Try a Trial	PRODUCT NAME: INOTERSEN AND SALT THEREOF, INCLUDING SODIUM SALTS; REG. NO/DATE: EU/1/18/1296 20180710
0957929	SPC/GB06/021	United Kingdom	⤷ Try a Trial	PRODUCT NAME: PEGAPTANIB, PREFERABLY IN THE FORM OF ITS SODIUM SALT; REGISTERED: UK EU/1/05/325/001 20060201
1874117	2014/032	Ireland	⤷ Try a Trial	PRODUCT NAME: DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING DOLUTEGRAVIR SODIUM; REGISTRATION NO/DATE: EU/1/13/892/001-002 20140121
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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