sodium nitrite Drug Patent Profile

Which patents cover Sodium Nitrite, and when can generic versions of Sodium Nitrite launch?

Sodium Nitrite is a drug marketed by Hope Pharms and is included in one NDA. There are two patents protecting this drug.

This drug has twenty-seven patent family members in fourteen countries.

The generic ingredient in SODIUM NITRITE is sodium nitrite. There are one thousand four hundred and seventy-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sodium nitrite profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Sodium Nitrite

A generic version of sodium nitrite was approved as sodium nitrite by HOPE PHARMS on February 14^th, 2012.

Summary for sodium nitrite

International Patents:	27
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	123
Clinical Trials:	58
Patent Applications:	1,397
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	Phase 1
University of Alabama at Birmingham	Early 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

Anatomical Therapeutic Chemical (ATC) Classes for sodium nitrite

V03AB	Antidotes
V03A	ALL OTHER THERAPEUTIC PRODUCTS
V03	ALL OTHER THERAPEUTIC PRODUCTS
V	Various

US Patents and Regulatory Information for sodium nitrite

sodium nitrite is protected by three US patents.

Patents protecting sodium nitrite

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hope Pharms	SODIUM NITRITE	sodium nitrite	SOLUTION;INTRAVENOUS	203922-001	Feb 14, 2012		RX	Yes	Yes			Y
Hope Pharms	SODIUM NITRITE	sodium nitrite	SOLUTION;INTRAVENOUS	203922-001	Feb 14, 2012		RX	Yes	Yes			Y	Y

International Patents for sodium nitrite

See the table below for patents covering sodium nitrite around the world.

Country	Patent Number	Title	Estimated Expiration
Portugal	3569237
Japan	5789519
Slovenia	2395834
Japan	2015199764	亜硝酸ナトリウムを含む医薬組成物 (SODIUM NITRITE-CONTAINING PHARMACEUTICAL COMPOSITIONS)
Japan	6059297

Supplementary Protection Certificates for sodium nitrite

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1912999	1490062-5	Sweden		PRODUCT NAME: SIMEPREVIR, OR A SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REG. NO/DATE: EU/1/14/924 20140516
2932970	SPC/GB18/041	United Kingdom		PRODUCT NAME: A COMBINATION COMPRISING DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF (E.G. DOLUTEGRAVIR SODIUM) AND RILPIVIRINE OR A PHARAMACEUTICALLY ACCEPTABLE SALT THEREOF (E.G. RILPIVIRINE HYDROCHLORIDE); REGISTERED: UK EU/1/18/1282 20180518; UK PLGB 35728/0055 20180518; UK PLGB 35728/0056 20180518; UK PLGB 35728/0057 20180518
2822954	LUC00083	Luxembourg		PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM; AUTHORISATION NUMBER AND DATE: EU/1/18/1289 20180625
1856135	SPC/GB20/016	United Kingdom		PRODUCT NAME: FOSTAMATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, OR A HYDRATE, SOLVATE OR N-OXIDE OF FOSTAMATINIB OR THE PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, ESPECIALLY FOSTAMATINIB DISODIUM, OPTIONALLY IN FORM OF A HYDRATE; REGISTERED: UK EU/1/19/1405 (NI) 20200113; UK PLGB 12930/0022 20200113; UK PLGB 12930/0023 20200113
2203431	2015/009	Ireland		PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REGISTRATION NO/DATE: EU/1/14/983 20150115